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Patient and physician views on the quality of care for inflammatory bowel disease after one-year follow-up: Results from SOLUTION-2, a prospective IG-IBD study

Digestive and Liver Disease, September 2017, Volume 49, Issue 9, Pages 997-1002

1 Introduction

Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory disorders occurring most often in early age; they require long-term and sometimes intensive health care based on the disease course, complications, and extra-intestinal symptoms. The quality of provided health care deeply influences quality of life in chronically ill patients; the identification and appropriate measurement of key dimensions of healthcare service delivery is an important requisite to improving quality in health care [1] . Discrepant views exist between patients and care providers with regard to the definition and prioritisation of quality issues 2 3 4 5 .

The S tudio O sservazionale qua L ità c U re malat TI e cr O niche intesti N ali observational study (SOLUTION, observational study of quality of care for inflammatory bowel disease) is an Italian multicentre study on the quality of care provided to Italian patients with IBD. The study was conducted at 36 clinical centres participating in the network of the Italian Group for Inflammatory Bowel Disease (IG-IBD), and it had a special focus on the differences in patient and physician perspectives. The study included a cross-sectional phase and a 12-month prospective phase to assess the variation in the quality of care (QoC) from the patient's point of view during one-year follow-up.

Based on the results of the cross-sectional study (SOLUTION 1), the perceived quality of care was overall satisfactory for the patients and the physicians, except for the subdomain of continuity of care. Patients scored total care significantly higher than the physicians, and the following conflicting perceptions were reported: physicians tended to underestimate their competence in the management of patients' problems and to consider the costs of medical management problematic, whereas the patients were more critical regarding the continuity of care and information provided [6] . Moreover the repeated analysis of QUOTE-IBD questionnaire allowed to explore the stability of the instrument used.

This paper reports the 12-month prospective phase results of the SOLUTION study (SOLUTION 2), focusing on the variations in quality of care perception during the cohort follow-up.

2 Materials and methods

The cohort of patients with IBD enrolled in the SOLUTION 1 study had a 12-month follow-up from March 2011 to February 2012 and was instructed to complete the second part of the study questionnaire.

All the patients were diagnosed based on commonly accepted clinical, endoscopic, and histological criteria at baseline [7 8] .

Each patient provided written, informed consent to participate in the SOLUTION study. At the 12-months follow-up visit, the patients, either outpatient or inpatient, were interviewed by their attending physicians. Demographic and clinical data were enquired and updated, including proximal extension or change in localization of the disease.

All the relevant data on healthcare resources related to IBD (hospitalization, surgery, outpatient visits, and diagnostic procedures) during the preceding year were recorded. IBD-specific medical treatments undertaken in the previous year and on-going treatments were recorded.

Clinical disease activity was assessed by using the Harvey–Bradshaw index [9] and the Lichtiger index [10] (modified Truelove and Witts) for patients with CD and UC, respectively.

Quality of care was evaluated by using the Quality of Care through the Patients' Eyes questionnaire (QUOTE-IBD) [11 12] , consisting of 10 generic and 13 disease-specific questions that allow assessment of the following:

  • -

    Performance (meant as the experiences concerning the functioning of medical practices and healthcare workers for each care aspect);

  • -

    Importance (defined as the weight that patients assign to various care aspects) of eight care dimensions: competence, autonomy, courtesy, accessibility, information, costs, continuity of care, and accommodation.

 

Importance and performance were measured for all the items on a four-point response scale. The combined effect of importance and performance is defined as the Quality Impact (QI). All the questionnaires with at least seven parameters evaluated (of the eight considered) were assessed for the total QI. The mean of the scores was calculated for the parameters evaluated. A detailed list of QUOTE-IBD questions is provided in Appendix A [13] .

The physicians' perspective on the quality of care provided was investigated using a similar questionnaire (Doctor's QUOTE-IBD), administered to physicians treating patients with IBD in the participating centres, which includes all the previous care dimensions of the previously developed questionnaire, excluding the dimension “accommodation” 11 12 13 . The scoring system was the same as for the patients.

The local ethic committees approved the SOLUTION 2 study.

3 Statistical analysis

For the QUOTE-IBD questionnaire, only fully completed scales were considered evaluable for the statistical analysis, i.e., no re-coding or interpolation of missing data was performed. For every QUOTE IBD category, a QI score [11] was calculated based on the importance and performance scores. The QI score ranged between 0 and 10. The QI for total care was calculated as the mean of the QIs from each category. In this case, patients with scores on at least seven of eight categories calculated were considered eligible for the analyses. For every care dimension (total care, accessibility, costs, accommodation, continuity of care, courtesy, information, competence, and autonomy), a QI score equal to or greater than nine was considered as patient satisfaction [12] . Wilcoxon test was used to test significance of differences in the QI scores for different subgroups:

  • Patients at basal versus final evaluation.

  • CD versus UC.

  • Patients in remission versus patients with active disease.

  • Patients in different age groups (≤30 years old, age between 30 and 50 years old, >50 years old).

  • Patients accessing the University or General Hospital.

 

4 Results

4.1 Patients’ characteristics

Of 992 patients evaluated in the cross-sectional phase of the SOLUTION I study, 936 completed the 12-month longitudinal phase of the study with the final follow-up visit. Fifty-six patients (6%) were lost to follow-up (no significant difference was found compared with patients with available follow-up data, including no difference in basal disease activity). Therefore, 936 patients were fully evaluable in the SOLUTION 2 study. Investigators documented a change in diagnosis during the follow-up from UC to CD (n = 4) or from CD to UC (n = 3) in seven patients (0.7%), and the final diagnosis was considered for subgroup analyses.

The mean follow-up duration was 12.2 months (SD, 1.04). The majority of patients were males (55%; 49% CD, 51% UC). Most of the subjects were outpatients (98%), and with inactive disease (68%). The mean value of the Harvey–Bradshaw index for patients with CD was 2.92 (range, 0–22). The mean value of the Lichtiger score index for UC was 2.68 (range, 0–15).

As previously reported [6] , the mean age at disease onset was 34.3 years (SD, 13.7), which was significantly lower for patients with CD (31.9 years; SD, 13) compared with patients with UC (p < 0.001), and majority of patients was diagnosed more than 3 years before the study enrolment (78%). Detailed patients’ characteristics are reported in Table 1 .

  Patients
  Ulcerative colitis (UC) Crohn’s disease (CD) Total
Number of patients, n (%) 474 (51%) 462 (49%) 936 (100%)
Female/male ratio, n 214/260 208/254 422/514
Median age, years (range)     44.2 (18–85)
Extent of CD, n (%)
Ileum NA 157 (34%) NA
Ileocolon NA 190 (41%) NA
Colon NA 82 (18%) NA
Other NA 28 (6%) NA
Location of UC, n (%)
Pancolitis 199 (42%) NA NA
Left-sided 194 (41%) NA NA
Proctitis 74 (16%) NA NA
Disease activity, N (%)
Yes 115 (25%) 106 (23%) 221 (24%)
No 350 (75%) 345 (77%) 695 (76%)
Hospitalised for IBD in the previous 12 months, n (%) 29 (6%) 65 (14%) 94 (10%)
Hospitalised at the follow-up visit, n (%) 5 (1%) 8 (2%) 13 (1%)
IBD-related surgery in the previous 12 months, n (%) 16 (3%) 42 (9%) 58 (6%)
Extraintestinal manifestations, n (%) 81 (17%) 140 (30%) 221 (24%)
Assisted by, n (%)
University hospital 136 (29%) 174 (38%) 310 (33%)
Regional hospital 338 (71%) 288 (62%) 626 (67%)

Table 1

 

During the longitudinal study, almost all patients (97% and 95% of patients with CD and UC, respectively, p = NS) underwent outpatient visits. The number of visits was significantly higher among patients with active disease at the end of the follow-up (n = 217; median, 4; IQR, 2–6) than among patients in remission at the 12-month follow-up (n = 660; median, 2; IQR, 1–4; p < 0.0001). Overall, 10% of patients were admitted as inpatients during the observation year (14% and 6% for patients with CD and UC, respectively; p = 0.0001), and a surgical procedure was required in 6% of cases (9% and 3% among patients with CD and UC, respectively, p < 0.001). Blood tests were performed at least once during the study period in 95% of cases (97% and 93% among patients with CD and UC, respectively, p < 0.005). During the observation period, 571 (61%) patients underwent at least one diagnostic imaging (70% CD and 52% UC, p < 0.0001); bowel loop ultrasound was the most common procedure (56% CD and 21% UC, p < 0.0001) followed by lower endoscopy (31% CD and 40% UC, p < 0.0001), and by CT/MRI enterography (24% CD and 2% UC, p < 0.0001).

Almost all patients with IBD (97%) were on medical treatment (no difference between patients with CD and UC, p = NS) at the end of the study. More than 50% of patients (n = 515), mostly UC patients (69% vs. 41% CD, p < 0.0001), were on aminosalicylates; no significant difference was recorded for steroid use (overall 7%, 6% and 8% among patients with CD and UC patients, respectively, p = NS) or immunosuppressants (overall 37%, 36% and 38% among patients with CD and UC, respectively, p = NS). Biological treatments were actively used at the end of the study overall by 23% of patients (34% and 11% among patients with CD and UC patients, respectively, p < 0.0001). The use of non-pharmacological or complimentary medicine was reported by 2% of patients, with no difference between patients with CD and UC, whereas nutrient/vitamin supplement use was reported by 21% of patients (26% and 17% among patients with CD and UC patients, respectively, p = 0.0005).

4.2 Physicians’ characteristics

Of the 72 physicians enrolled at basal, 63 (88%) completed the follow-up questionnaire. Physicians were mainly gastroenterologists (59/63, 94%), with median experience of 12 years (range, 1–35 years) in IBD care. Their IBD workload was of 50 consultations per month (median; range, 15–560).

4.3 QUOTE-IBD analysis

4.3.1 Patients’ evaluations

A QI score higher than 9.0 points, regarded as patient satisfaction, was reported overall at the end of the follow-up by 80% of patients; all the care sub-dimensions considered in the QUOTE-IBD score were satisfactory well more than 80%, except for “Continuity of Care” (mean, 8.3; SD, 1.49) which was scored satisfactory only by 34% of the patients. Compared with the basal scores, satisfaction was confirmed in 71% of patients, and 9% of patients were unsatisfied at basal. In contrast, 9% of patients unsatisfied at basal evaluation replicated their score, and 11% downgraded their positive basal score to unsatisfactory after the follow-up (p = NS). Variations from basal to final scores were not significant in any care sub-dimension explored by the QUOTE-IBD score clinical subgroups as disease type (CD vs. UC), sex, disease activity, or age (p = NS for all comparisons). Detailed results of basal and final QUOTE-IBD scores for patients based on different clinical subgroups are plotted in Fig. 1 (A–D).

gr1
 

Fig 1
(A–D). QUOTE-IBD results overall and according to sub-dimensions, at basal and final evaluations based on the disease type (crohn’s disease [CD] versus ulcerative colitis [UC], (A)), to disease activity (active or remitting disease, (B)), age subgroup (18–30, 30–50, and >50 years, (C)) and sex (female or male, (D)). Differences for all comparisons between basal and final observations were not statistically significant.

 

No cross-correlation was observed between the QI scores and frequency of outpatient visits, medical treatments undertaken during the 12-month follow-up period, or disease activity measured at the final observation (p = NS for all comparisons). No difference was found for QUOTE-IBD score among the centres in the North, Central, and South Italy, and variations in satisfaction were not associated to the geographical location of the centre.

A univariate logistic regression of QUOTE-IBD score based on number of visits was used to rule out the potential effects of the number of visits during the previous year, but the results were not significant either for UC (odds ratio [OR], 1.023; 95% confidence intervals [CI], 0.919–1.137) or CD (OR, 1.028; 95% CI, 0.947–1.116).

4.3.2 Physicians’ evaluations and comparison with patient’s evaluations

At the follow-up visit, the QUOTE score of the 63 responders was not significantly different from that of the 72 physicians responding at basal visit, either considering the complete QUOTE questionnaire or the individual score sub-dimension (p = NS for all comparisons). In addition, the analysis based on the frequency of score/subscore equal or greater than 9 points did not outline significant differences (p = NS for all comparisons).

Physicians’ and patients’ evaluations for QUOTE-IBD score were again significantly different. The QI score for total care of the physicians (9.01) was significantly lower than that of the patients (9.40; p = 0.0001). A satisfactory level of QI was reached in 63% of physicians and 81% of patients (p = 0.002). The sub-dimensions of “Competence” (p < 0.0001), “Accessibility” (p = 0.02), and “Costs” (p = 0.0003) were scored significantly lower by the physicians than by patients. The patients scored significantly lower in the “Continuity of Care” subdomain than the physicians (p < 0.0001). Results of basal and follow-up QUOTE-IBD results among patients and physicians are plotted in Fig. 2 .

gr2
 

Fig. 2
Results of the QUOTE-IBD scores overall and based on score sub-dimensions at basal and final evaluations for patients and physicians. Differences were not statistically significant when basal and final observations were considered.

 

The comparison of doctors below (n = 26, 41%) and above (n = 37/63, 59%) the median of 12 years of caring patients with IBD was not significantly different, both considering the total QUOTE score and sub-dimensions of care.

5 Discussion

The SOLUTION-2 study reports the longitudinal evolution of the perception of the IBD-specific quality of care, following the results of the SOLUTION-1 study [6] .

The study cohort of 992 patients enrolled at basal evaluation was available for final evaluation at 1 year in the majority of cases (936 completed cases, 94%), and no major clinical difference was noted comparing the two groups of patients.

The focus of the SOLUTION-2 was mainly on possible variations in the perceived quality of care, which was substantially identical to the basal one [6] , which was very good based on the standards previously set [11 12] . Similarly in the cross-sectional basal evaluation, the IBD-specific instrument used to measure perceived quality of life was the widely validated QUOTE-IBD questionnaire 11 12 13 , which was also recognised as a reliable and robust instrument in this field by the European Crohn’s and Colitis Organization [14] .

The study design, requiring to repeat the evaluation of the perception of quality of cares one year after the first analysis, allowed to find a remarkable stability of patients’ and physicians’ perceptions of the quality of cares, leading to an additional, indirect, validation of the QUOTE-IBD questionnaire in its repeated use. Actually in previous studies the questionnaire was used for cross-sectional evaluations only [11 12 15 16 17 18 .

The quality of care influences quality of life [19] , and a low quality of care is associated to adverse clinical outcomes [20] . However, the patient’s perception might differ from the “absolute” health care quality measured using quality indicators [21] , depending on the increasing utilization of health care resources.

We therefore expected to highlight in our study the differences of perception of quality of care based on activity or to health care utilization during the previous year. Nonetheless, the results were not significantly different comparing such subgroups. Similarly, disease type, age subgroup, or sex did not significantly affect perceived quality of care (substantially in line with the basal evaluation in the SOLUTION-1 study [6] ).

Perceived quality of care among this large cohort of patients was very high at the basal evaluation and remained very high at the final evaluation, not allowing any major/significant increase at the end of the observation period. Larger variations could be expected only if levels of satisfaction would have been much lower than observed.

The only significant differences in quality of care persisted in the comparison of physicians’ and patients’ views on quality of care. Consistent with the basal evaluation, physicians significantly over-rated their performance at least for the “Continuity of Cares” sub-domain of the QUOTE-IBD score compared with the patients’ judgement, whereas they under-rated other sub-domains, such as “Costs”, “Accessibility”, and “Competence” compared with patients’ views. Once more, the doctors tended to over-rate technical difficulties, which in their views the patients face in their contact with the Italian National Health System, whereas the only suboptimal quality domain perceived by patients relates to the chance of reaching their treating physicians with continuity, which doctors consider significantly less important.

During the observation year, the health consumption for outpatient visits, admissions, and treatments was elevated. Perceived quality of care for the intensity of care used had no chance of being corrected, if not measuring the absence of effects, but also of the number of visits on perceived quality of care (not significant). However, this item might become the focus of a comparative study among different countries with different health system organisations.

This study replicates very good results on measurement of perceived quality of care in a large cohort of Italian patients with IBD across the country. No new signal of low perceived quality of care emerged, and a very large amount of patients continued to score the care received high over the acceptable level.

Conflict of interest

None declared.

Funding

The SOLUTION 2 study was funded by IG-IBD . The Chiesi Pharmaceutical Group supported the study with an unrestricted grant which funded the CRO MEDIDATA.

Acknowledgements

The authors are indebted to the patients and to the Italian Association of Patients (AMICI Onlus Italia) for their great enthusiasm and important contributions to this study.

The authors are grateful to Mrs. Chiara Pennati for the statistical analysis.

The authors thank all collaborators from participating centres who contributed with the inclusion of patients:

Rita Monterubbianesi, San Camillo-Forlanini Hospital, Rome, Italy; Fabiana Castiglione, Federico II University, Naples, Italy; Ada Corbellini, Vizzolo Predabissi Hospital, AO Melegnano, MI, Italy; Manuela Merli, “La Sapienza” University, Rome, Italy; Giovanni Casella, Desio Hospital, Italy; Renata D’Incà, University of Padua, Italy; Ambrogio Orlando, “V. Cervello” Hospital, Ospedali Riuniti “Villa Sofia-Cervello” University of Palermo, Italy; Fabrizio Bossa, CSS-IRCCS Hospital, San Giovanni Rotondo, Italy; Patrizia Doldo, University of Catanzaro, Italy; Pierenrico Lecis, San Martino Hospital, Belluno, Italy; Daniela Valpiani, Morgagni Hospital, Forlì, Italy; Silvio Danese, Istituto Clinico Humanitas IRCCS, Rozzano,MI, Italy; Maurizio Vecchi, IRCCS Policlinico San Donato Milanese, Italy; Giorgio Zoli, Cento Hospital, Italy; Licia Snider, Sant'Anna Hospital, Italy; Gianni Imperiali, Valduce Hospital, Como, Italy; Ivano Lorenzini, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Italy; Vincenza Di Leo, Dolo Hospital, Italy; Guido Basilisco, IRCCS Ca' Granda Fondazione Policlinico, Milan, Italy; Gabriele Riegler, II Naples University, Italy; Claudia Cucino, Istituto Clinico Città Studi di Milano, Italy; Giovanni Fornaciari, Arcispedale Maria Nuova, Reggio Emilia, Italy; Rocco Spagnuolo, University of Catanzaro, Italy; Alberto Prada, A.O.G. Salvini, Rho Hospital, Italy; Angelo Zelante, Azienda Ospedaliero-Universitaria Ferrara, Italy; Ilaria Arena, Rho Hospital, ASST Rhodense, Italy.

Appendix A Supplementary data

The following are Supplementary data to this article: Attached file

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