Patient Satisfaction With Collagenase

Patient Satisfaction With Collagenase

EDITOR’S CHOICE Patient Satisfaction With Collagenase Jack Bradley,* David Warwick, MD* Purpose To establish patient satisfaction after collagenase ...

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EDITOR’S CHOICE

Patient Satisfaction With Collagenase Jack Bradley,* David Warwick, MD*

Purpose To establish patient satisfaction after collagenase clostridium histolyticum (CCH) injection. Methods In a cross-sectional study, 213 patients who had been treated for Dupuytren disease with CCH were reviewed between 37 and 1421 days after injection. Results A total of 73% of the patients were very satisfied or satisfied, and 21% were dissatisfied; 75% would probably or definitely have CCH again, whereas 17% probably or definitely would not. We found that satisfaction and willingness to undergo a second treatment decreased over time and had a negative relationship with recurrence. Dissatisfaction was greater in those with a poor initial outcome but not in those with an initial complication. Of 212 patients, 78 had previously experienced surgery for Dupuytren disease of whom 71% would prefer CCH to surgery and 15% the converse. Satisfaction shows a relationship with function as measured by both QuickDASH and the Southampton Dupuytren Scoring Scheme. Conclusions Patient satisfaction with CCH is generally high but deteriorates over time as the disease recurs. To manage patient expectation, this issue should be made explicit to patients in the consent process. Clinical relevance Overall satisfaction with CCH is high, with initial satisfaction rates especially good. Forewarning of complications and recurrence can help maintain satisfaction levels. (J Hand Surg Am. 2016;41(6):689e697. Copyright Ó 2016 by the American Society for Surgery of the Hand. All rights reserved.) Key words Collagenase, satisfaction, patient-related outcome measures, complications, collagenase clostridium histolyticum.

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(CCH) has been established as one of the options for treating Dupuytren disease (DD). Recent articles have reported its efficacy and relative safety.1e4 The presence of angular deformity in the digits only correlates weakly with hand function in DD.5e9 Patient-related outcome measures are generally more meaningful in assessing the real purpose of clinical medicine—patient function and satisfaction—than OLLAGENASE CLOSTRIDIAL HISTIOLYTICUM

From the *University Hospital Southampton and University of Southampton, Southampton, United Kingdom. Received for publication December 10, 2015; accepted in revised form March 7, 2016. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Corresponding author: David Warwick, MD, Orthopaedic Department, University Hospital Southampton and University of Southampton, Southampton SO16 6UY, UK; e-mail: [email protected] 0363-5023/16/4106-0005$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2016.03.003

more traditional objective surgeon-based measures. Scores specific to DD such as the Unité Rhumatologique des Affections de la Main Scale and the Southampton Dupuytren Scoring Scheme (SDSS) have been devised but have not been fully validated.5,10 Patient satisfaction is therefore a fundamental outcome measure that encompasses many aspects of treatment. Witthaut et al4 reported that 71% of 587 patients treated with CCH were “very satisfied” and 21% “quite satisfied” 9 months after treatment. Warwick et al1 reported that 87% of 254 patients were “very satisfied” or “satisfied” 6 months after injection. The simplicity of CCH and a median return to function in just of 4 days1 may prompt high patient satisfaction. However, drivers of reduced satisfaction may include expense, early complications such as pain, skin splitting, or bruising,2 and recurrence. By 3 years after CCH injection, 56% of proximal interphalangeal cords and 27% of metacarpophalangeal cords have recurred. This increases to 66% and 40% respectively by 5 years after treatment.11

Ó 2016 ASSH

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Published by Elsevier, Inc. All rights reserved.

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FIGURE 1: The questionnaire. (Continued.)

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Any Other Comments:

FIGURE 1: (Continued.)

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ParƟcipants (%)

100% 80% 60% 40% 20% 0%

Time Elapsed (days) UnsaƟsfied

SaƟsfied

Would not have CCH again

Would have CCH again

FIGURE 2: Proportion who are satisfied/dissatisfied and willing/unwilling to have CCH again over time between injection and assessment. For ease of interpretation, responses have been combined to satisfied/unsatisfied and willing/unwilling to have CCH again, whereas the “unsure” categories have been excluded.

We have studied a sample of patients who had been treated with CCH to determine their satisfaction with the treatment, to identify reasons for dissatisfaction, to determine whether satisfaction changes over time, and to consider whether satisfaction could be improved.

did not participate, 4 were deceased, 2 had developed dementia, 5 had withdrawn from follow-up, and 3 wanted to participate but could not do so before the end of data collection. The others could not be contacted. The median age was 68 years (range, 21e89 years). The median time elapsed between in injection and completing the questionnaire was 763 days (range, 37e1,421 days). Overall, 44.1% were very satisfied, 28.6% somewhat satisfied, 6.6% neither satisfied nor unsatisfied, 9.9% somewhat unsatisfied, and 10.8% very unsatisfied. A total of 45.7% would definitely have CCH again, 28.6% probably would, 9.0% were unsure whether they would or would not have CCH again, 6.7% probably would not, and 10.0% definitely would not. From the free text entries, reasons for those willing to have the treatment again (where more than 10% responded) were corrected deformity (26%), quick recovery (14%), and improved function (12%); reasons for not wishing to have the CCH again were concerns about the drug not having worked adequately (31%) and concerns about recurrence (29%), painful procedure (23%), and better outcome with surgery (11%). Satisfaction declined as more time passed between the injection and the questionnaire, whereas the willingness to have the treatment again remained fairly constant (Fig. 2). Of 212 patients, 78 had previously experienced surgery for DD. Among this subset, 46% would definitely prefer CCH over surgery, 24% probably would, 14% were not sure, 8% probably would not prefer

MATERIALS AND METHODS All patients who have been treated with CCH in our center are entered into a database. Data recorded included the QuickDASH and SDSS before treatment, the deformity before injection, the correction after injection, and any early complications associated with the injection and manipulation. The current study had approval from the Faculty of Medicine Ethics Committee. We contacted by telephone, post, or email all patients who had been treated between May 2011 and September 2014. The patient’s invitation included an explanation of the study and the option to withdraw at any time without prejudice. A questionnaire (Fig. 1) was competed by email or by post, or by telephone, and for some patients a combination. Patients were asked to complete the SDSS5 and the QuickDASH. Each score was compared with the preinjection score and the change used to correlate with satisfaction. RESULTS A total of 262 patients were entered into the database of whom 213 (81.3%) participated. Among those who J Hand Surg Am.

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80% 60% 40% 20% 0% Complete

Almost complete

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IniƟal correcƟon raƟng

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Would not have CCH again

Would have CCH again

FIGURE 3: A Satisfaction and B willingness to have CCH again according to the patient’s rating of initial correction. For ease of interpretation, responses have been combined to satisfied/unsatisfied and willing/unwilling to have CCH again, whereas the “unsure” categories have been excluded.

CCH over surgery, and 8% definitely would not. From the free text entries, reasons for preferring CCH included its minimally invasive nature (11.5%), absence of anesthesia (10.3%), and quicker recovery (33%). The main reason for preferring surgery was that surgery had been successful whereas CCH had not (10.3%). Satisfaction and willingness to retreat with CCH also appeared to show a relationship with the patient’s rating of the initial correction initial correction (Fig. 3A, B). The occurrence of complications after treatment (bruising, skin split, pain, and axillary pain) did not influence satisfaction (Table 1). J Hand Surg Am.

Patients were asked about their own opinion on whether the disease had recurred. In the patient’s opinion (notwithstanding the distinction between recurrence and extension), it had recurred to the original deformity in 17%, partially recurred in 11%, minimally in 13%, and no perceived recurrence in 59%. Perceived recurrence also showed a relationship with the satisfaction and willingness to have the treatment again (Fig. 4A, B). A total of 152 patients completed the SDSS and 187 the QuickDASH score, both before the injection and at follow-up. The greater the improvement in the functional scores, the greater the patients’ satisfaction (Fig. 5A, B). r

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The number/percentage in each column represents the number/percentage of participants with that particular complication.

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18 22%

48% 26

4 39%

30%

DISCUSSION In this study, we have concentrated on the patient’s perception of initial correction, recurrence, and satisfaction rather than objective measures of angulation. The issue of which is more important—patientrelated outcome measures or objective measures such as range of movement—is controversial. Once a treatment is established with clear data on efficacy, safety, and cost based on randomized comparison with existing treatments, then perhaps patient perception carries more weight. Otherwise, as remains the case with CCH, patient preference and perception may need to be tempered by objective data and by proper explanation of the uncertainty. The satisfaction scale was derived in an ad hoc manner; the reliability is unknown but the 5-point scale is widely used in surveys and appears to have face validity. This cross-sectional study shows that, as patients experience disease recurrence, they are more likely to become dissatisfied (Fig. 5). This is similar to the experience of needle fasciotomy.12 As expected, satisfaction is also related to whether or not the injection is perceived by the patient to be effective (Fig. 3A). However, it must be appreciated that the patient is unlikely to be able to distinguish between true recurrence (ie, the disease returning at the site of the previous treatment) and extension (disease appearing away from the site of treatment).13 We did not find that early complications such as bruising and skin tearing, albeit potentially alarming, affected later satisfaction (Table 1). This may reflect both the careful consent given to patients before injection whereby patients were clearly warned of these complications, and also the transient nature of these complications. We would therefore emphasize the need for a full discussion of these possible complications before treatment. The function measured by the QuickDASH and SDSS was also associated with satisfaction (Fig. 5A, B). The better the improvement in hand function after treatment with CCH, the higher the reported satisfaction. The smaller the improvement, or if function has deteriorated since treatment, the lower the reported satisfaction. Deteriorating function is likely to be driven by recurrence. Although the percentage willing to have CCH again appeared to remain fairly constant regardless of the time between injection and assessment, satisfaction declined (Fig. 2). Nevertheless, most people were still satisfied and thus would still choose to have the CCH again; even some of those dissatisfied with a poor initial result (Fig. 3B) or recurrence (Fig. 4B) would still choose CCH for the perceived advantages (quick recovery, avoiding surgery).

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16 13%

22% 4

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Armpit pain

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Skin split

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44% 41

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Complication

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Reported Complications and Patient Satisfaction TABLE1.

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Very Satisfied

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would not have CCH again

would have CCH again

FIGURE 4: A Relationship between perceived recurrence and satisfaction and B willingness to have CCH again. For ease of interpretation, responses have been combined to satisfied/unsatisfied and willing/unwilling to have CCH again, whereas the “unsure” categories have been excluded.

There are drawbacks in our study. Our response rate of more than 80% is probably adequate, but it is possible that those with lower satisfaction and thus disappointment might avoid participation thus skewing the results toward a more favorable outcome. Equally, it may be that those with low satisfaction are more likely to participate as an opportunity to vent their dissatisfaction. Our study was limited by its cross-sectional nature. This allows inferences about trends over time within a population, but further confirmation should be derived by a large cohort study with prospective assessment of each patient’s satisfaction and perception of recurrence at set time points. J Hand Surg Am.

Our study is also dependent on the design of the questionnaire. Patients may, when deciding whether they are satisfied or not, give different weight to aspects such as their perception of the doctor, the treatment environment, the complications, the meeting of expectations, the cost, and the appearance. For this reason, we used a leading question “How satisfied are you that the Xiapex injection has helped your problem?” with the supplementary question “Would you have Xiapex again?” and the opportunity for free text. As has been described in the previous literature,14 an adverse occurrence has a greater impact on overall r

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-10 to -6

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0

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Change in QuickDASH score

B

UnsaƟsfied

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FIGURE 5: The relationship between patient satisfaction and change in function as scored by A SDSS and B QuickDASH. For ease of interpretation, responses have been combined to satisfied/unsatisfied, whereas the “unsure” category has been excluded. A person with a high SDSS/QuickDASH score has poor hand function. Therefore, a negative change in score means that hand function has improved compared with pre-CCH injection, a score of zero equates to no change in function, and a positive change means that hand function is now worse.

ACKNOWLEDGMENT We would like to acknowledge Dr Daniel Graham who established the database on which this project was based.

satisfaction than an advantageous one. Therefore, the negative outcome of failing to meet expectations has a larger effect than exceeding them by the same magnitude. Accordingly, even if a patient experiences an excellent reduction in deformity with CCH, but then experiences a recurrence, they tend to report lower satisfaction levels than a patient who experiences less of an improvement but has no recurrence. Expectations have to be managed to maintain patient satisfaction and to avoid disappointment. We believe that our careful discussion before injection avoided dissatisfaction because of complications, but we now also believe that patients must be very clearly warned about the high incidence of recurrence. J Hand Surg Am.

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10. Beaudreuil J, Allard A, Zerkak D, et al. Unité Rhumatologique des Affections de la Main (URAM) scale: Development and validation of a tool to assess Dupuytren’s disease-specific disability. Arthritis Care Res (Hoboken). 2011;63(10):1448e1455. 11. Peimer C, Blazar P, Coleman S, Kaplan FT, Smith T, Lindau T. Dupuytren contracture recurrence following treatment with collagenase clostridium histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5-year data. J Hand Surg Am. 2015;40(8): 1597e1605. 12. van Rijssen AL, ter Linden H, Werker PM. Five-year results of a randomized clinical trial on treatment in Dupuytren’s disease: percutaneous needle fasciotomy versus limited fasciectomy. Plast Reconstr Surg. 2012;129(2):469e477. 13. Kan H, Verrijp FW, Huisstede BM, Hovius S, van Nieuwenhoven CA, Sulles RW. The consequences of different definitions for recurrence of Dupuytren’s disease. J Plast Reconstr Aesthet Surg. 2013;66(1):95e103. 14. Shankar V, Carpenter G. Handbook of Marketing Strategy. Cheltenham, England: Edward Elgar Publishing; 2013.

fasciectomy for Dupuytren’s contracture. J Hand Surg Eur Vol. 2015;40(2):141e149. Witthaut J, Jones G, Skrepnik N, Kushner H, Houston A, Lindau TR. Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren contracture: short-term results from 2 open-label studies. J Hand Surg Am. 2013;38(1):2e11. Arvind M, Vadher J, Ismail H, Warwick D. The Southampton Dupuytren’s Scoring Scheme. J Plast Surg Hand Surg. 2014;48(1):28e33. Budd HR, Larson D, Chojnowski A, Shepstone L. The QuickDASH score: a patient-reported outcome measure for Dupuytren’s surgery. J Hand Ther. 2011;24(1):15e20. Degreef I, Vererfve PB, De Smet L. Effect of severity of Dupuytren contracture on disability. Scand J Plast Reconstr Surg Hand Surg. 2009;43(1):41e42. Engstrand C, Borén L, Liedberg GM. Evaluation of activity limitation and digital extension in Dupuytren’s contracture three months after fasciectomy and hand therapy interventions. J Hand Ther. 2009;22(1):21e27. Zyluk A, Jagielski W. The effect of the severity of the Dupuytren’s contracture on the function of the hand before and after surgery. J Hand Surg Eur Vol. 2007;32(3):326e329.

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