ORIGINAL ARTICLE

Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse Hema D. Brazell, MD,* David M. O'Sullivan, PhD,† Allison Forrest, RN,* and John F. Greene, MD‡ Objectives: The aim of this study was to evaluate if the addition of a decision aid (DA) decreases decisional conflict in women presenting for the management and treatment of pelvic organ prolapse (POP). Methods: Women scheduled for the evaluation and management of POP were randomized into either of 2 groups: standard counseling (SC) alone (n = 51) or SC plus a DA (n = 53). Upon completion of their initial visit, patients filled out a 16-item decisional conflict scale and short form general health survey. Values were assessed for normality and compared between groups. Normally distributed, continuous data were evaluated with a Student t test. A χ2 test was used to compare selected categorical characteristics between groups. Differences in distributions of low and high decisional conflict were assessed with a Mann-Whitney U test. Results: One hundred four women were randomized for this analysis. Baseline characteristics, including pelvic prolapse examination measurements, did not significantly differ between groups. The addition of a DA to SC did not significantly lower the level decisional conflict patients faced when deciding on a treatment plan (P = 0.566). There were no significant differences between groups in the following subscores: uncertainty, values clarity, support, effective decision, and informed. In addition, there were no between-group differences in choice of treatment plan (conservative management, pelvic floor physical therapy, pessary, and surgery; P = 0.835). Conclusions: In this relatively small sample, the addition of a DA to SC for women with POP does not significantly decrease the level of decisional conflict in making treatment-related decisions. Key Words: decision aid, pelvic organ prolapse (Female Pelvic Med Reconstr Surg 2015;21: 231–235)

P

elvic organ prolapse (POP) is a common condition in the female population, and its prevalence increases with age. There are over 200,000 operations performed yearly for prolapse alone, and Wu et al1 predict that the number of women with POP will increase 46% from 2010 to 2050.2 Management options are plentiful and include conservative management, pelvic floor physical therapy, vaginal pessary, and/or surgery. The decision to proceed with surgery may be difficult, and counseling can be complex, especially if there is prolapse of multiple vaginal compartments. Factors contributing to uncertainty not only involve the perceived potential advantages and disadvantages of the procedure, but also include conflict in the form of unclear perceptions of others, lack of resources, and lack of knowledge.3 Previous studies conclude that decision aids (DAs) may improve patient knowledge, physician-patient communication, From the *Department of Obstetrics and Gynecology, Division of Urogynecology, †Department of Research Administration, and ‡Department of Hospital Administration, Hartford Hospital, Hartford, CT. Reprints: Hema D. Brazell, MD, 890 W. Faris Rd, Suite 510. Greenville, SC 29605. E-mail: [email protected]. Conflicts of interest and source of funding: The decision aid used for this study was developed by Healthwise and provided to the authors at no cost. No reprints available. Accepted as an oral presentation at the Society of Gynecologic Surgeons 40th Annual Scientific Meeting, March 23 to 26, 2014. Clinical trial registration: clinicaltrials.gov, www.clinicaltrials.gov, NCT01798082. Copyright © 2014 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/SPV.0000000000000149

decisional conflict, and patient satisfaction.4–6 However, to date, the role for a DA among women presenting for evaluation and management of prolapse is unknown. To this end, we sought to evaluate if the addition of a POP DA to the standard counseling (SC) process decreases the amount of decisional conflict women face when choosing a plan of care. As a secondary outcome, we sought to evaluate if the addition of a DA led to differences in choice of treatment plan between groups.

MATERIALS AND METHODS This was a randomized controlled trial involving women presenting to a female pelvic medicine and reconstructive surgery office at a tertiary care center for evaluation and management of POP. Upon obtaining institutional review board approval, the trial was registered with clinicaltrials.gov (NCT01798082), and recruitment occurred from November 2012 through May 2013. English-speaking female patients aged 18 years and older who were scheduled for a consultation visit for POP were eligible for inclusion in this study. Women who declined or expressed unwillingness to being contacted for participation, who did not answer their screening phone call, whose appointment was within 7 days of consult request, and those with a planned concomitant nongynecologic procedure were excluded. Consecutive new patients referred for the evaluation and management of POP were contacted via telephone before the initial consultation visit to ascertain interest for this study (screening phone call). Patients expressing interest in participating were randomized to 1 of 2 groups: those who received SC alone and those who received a DA in addition to their SC (SC + DA). In our practice, new patient visits last an average of 30 minutes. Nonsurgical and surgical options are always discussed with the patient, and pamphlets on pelvic prolapse are routinely reviewed every time. Flip chart diagrams are also readily available at the discretion of the provider; however, they are not always implemented. The DA is publicly available on the Internet,7 and a written version complete with images was provided at no cost by Healthwise for this study. The DA defines POP, provides details on nonsurgical and surgical options for the treatment of prolapse, describes risks associated with surgery, and briefly details postoperative expectations. There are also testimonials, both from women who choose surgery and those who opt for more conservative measures. Patients were randomized 1:1 using a random numbers table in blocks of 6. Standard office practice is to mail all new patients a personal health history form as well as pelvic floor disorder questionnaires, which are completed at home and brought with them to the initial visit. For patients in the DA arm, the aid was mailed along with these items for their review before the first visit. After the consultation, consenting patients completed a 16-item decisional conflict scale (DCS, Appendix 1) and short form general health survey (SF-12v2). The DA was given before the initial visit so that any questions that may have arisen as a result of reading the aid could have been addressed at that visit. In addition, most patients make their treatment plan decision at that first consultation visit. The DCS was developed and found to be psychometrically valid among individuals deciding whether or not to proceed with

Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 4, July/August 2015

www.fpmrs.net

231

Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Brazell et al

Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 4, July/August 2015

FIGURE 1. Flow chart of subjects in the study.

influenza vaccination or breast cancer screening. It assesses the extent to which patients report unresolved decisional needs and related deficits in knowledge pertaining to their care and treatment options.8 It has not yet been used in studies of women presenting for the evaluation and treatment of POP. The DCS comprises 3 subscales: decision uncertainty, factors contributing to uncertainty, and perceived effective decision making. These Likert scales use response categories of strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree, which are scored as 0 to 4, respectively. The 16 items are then (a) summed, (b) divided by 16, and (c) multiplied by 25. Scores range from 0 to 100, and DCS scores greater than 37.5 are associated with decision delay or feeling unsure, whereas scores less than 25 are associated with implementing decisions.9

232

www.fpmrs.net

Thus, subjects with scores greater than 37.5 were classified as having high decisional conflict. As a secondary outcome measure, we sought to determine rates of regret associated with choice of treatment plan. Subjects were contacted 3 months after their treatment decision had taken effect todetermine if they regretted their initial plan. Thus, subjects choosing conservative management were contacted 3 months after the initial visit, pessary subjects were contacted 3 months after initial pessary fitting, surgical subjects were contacted 3 months after their surgery, and pelvic floor physical therapy patients were contacted 3 months after their first session to complete a decision regret survey (DRS). The DRS was mailed to all subjects who then were asked to complete the survey and mail it back in a self-addressed stamped envelope. © 2014 Wolters Kluwer Health, Inc. All rights reserved.

Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 4, July/August 2015

The DRS measures remorse or regret after a certain decision is made. Similar to the DCS, it comprises a series of Likert scale statements. Scores range from 0 to 100, where 100 represents the highest amount of remorse/regret. This scale has been shown to correlate well with decisional conflict.10 For each participant, demographic information, medical history, and stage of pelvic prolapse based on the POP Quantification (POP-Q) system11 were collected. The SF-12v2 provides a measure of functional health and well-being and comprises 2 scales—physical and mental. Scores are computed and range from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health. Responses from the questionnaires were entered into a database, and the scores were tabulated according to the respective user manuals.9 Sample size calculation conducted for the primary outcome required 104 participants to detect a difference of 14 points in the DCS between the null hypothesis that both group means are 35.0 and the alternative hypothesis that the mean of the +DA group is 21.0, with estimated group SD of 25.0 each using a 2-sided t test with an α of 0.05 and 80% power. These values equate to an effect size of approximately 0.55 (a medium effect size), which according to Ottawa Research Hospital Institute's User Manual is a clinically meaningful difference.8 Values were assessed for normality and compared between groups. Normally distributed, continuous data were evaluated with a Student t test. Differences in distributions of low and high decisional conflict were assessed with a χ2 test. SPSS v. 19.0 (IBM, 2010) was used for all analyses, with an a priori α level set at 0.05 such that all results yielding P < 0.05 were deemed statistically significant.

RESULTS A total of 220 new patient consultation requests were made between November 2012 and May 2013. Sixty-one patients did not meet eligibility criteria, and 16 refused to participate. Thus, 72 subjects were randomized to the SC group, and 71 patients randomized to the SC + DA group. Thirty-nine randomized subjects were either missed by the research assistant at their new patient visit and thus did not receive a DCS questionnaire to complete or they canceled their appointments and did not reschedule a new one (Fig. 1). Baseline characteristics, including POP-Q stage, did not significantly differ between groups (Table 1). Subjects who were enrolled but subsequently missed/refused were significantly older than those who completed the study (67.1 [13.3] vs 60.7 [12.1] years; P = 0.032), but they did not otherwise differ in baseline characteristics. Overall mean (SD) DCS scores in the SC group were 14.1 (16.1) compared with 15.8 (13.9) in the group that also received a DA (P = 0.566). There were no significant differences between groups in the following subscores: informed, values clarity, support, uncertainty, and effective decision making (Table 2). The combination of the informed, values clarity, and support subscores, which comprise the factors contributing to the uncertainty subscale of the DCS, also did not significantly differ between groups (P = 0.256). Treatment plans included conservative management with watchful waiting, trial of vaginal pessary, surgery, and referral for pelvic floor physical therapy. There were no significant betweengroup differences in the choice of treatment plan (P = 0.835). Of the 26 subjects who initially decided upon conservative management, 2 had changed their minds and were successfully fitted with a vaginal pessary, one changed her mind in favor of a pessary and is now scheduled for surgery in 2014, and another is also scheduled for surgery in 2014. One of the 20 subjects who chose trial of vaginal pessary changed her mind in favor of surgery, one of the 52 subjects choosing surgery ultimately opted © 2014 Wolters Kluwer Health, Inc. All rights reserved.

DA on Decision Making for POP Treatment

TABLE 1. Baseline Patient Characteristics

Participants (N = 104) Age, mean (SD), y Mean BMI, mean (SD) Median parity (IQR) Prior POP surgery, n (%) Prior incontinence surgery, n (%) Menopause, n (%) Smoke, past or present, n (%) SF-12v2 PCS MCS POP-Q stage, median (%) 0 1 2 3 4

SC

SC + DA

P

51 60.4 (11.0) 27.8 (5.7) 2 (2–3) 9 (17.6) 8 (15.7) 38 (76.0) 20 (39.2)

53 61.0 (13.2) 27.8 (5.5) 2 (2–3) 5 (9.4) 3 (5.7) 42 (79.2) 19 (35.8)

— 0.819 0.963 — 0.220 0.097 0.693 0.723

46.2 (12.5) 45.1 (12.5) 2 (2–3) 0 (0.0) 4 (7.8) 27 (52.9) 20 (39.2) 0 (0.0)

49.1 (11.9) 46.6 (11.3) 3 (2–3) 0 (0.0) 3 (5.8) 22 (42.3) 26 (50.0) 1 (1.9)

0.914 0.583 0.489

BMI, body mass index; IQR, interquartile range; PCS, physical component score; MCS, mental component score.

for conservative management, and one of the 6 subjects referred for pelvic floor physical therapy ended up with a pessary. Fifty-four of 104 subjects completed the DRS for a response rate of 52%. There was no significant difference noted between groups in mean scores with the SC + DA group mean (SD) of 12.1 (18.5) compared with 10 (20.1) in the SC group (P = 0.969).

DISCUSSION Decision aids allow patients to share in medical decision by weighing risks, benefits, and alternatives in an unbiased manner.6 The utility of a DA in the urogynecologic population was unknown before this study. In our cohort, the addition of a DA to SC did not affect the level of uncertainty subjects faced when choosing a treatment plan for POP nor did it affect choice of treatment between groups. Subjects receiving a DA in addition to SC were no more likely than those receiving SC alone to feel less conflicted about their decision regarding the management of prolapse. Perhaps this is a result of our readily available prolapse aids that are often reviewed at the initial consultation as well as the lengthy discussions that are a standard part of our practice. However, the overall decision conflict mean scale scores were low in both groups, suggesting that this particular method of SC alone suffices in this specific patient population. The decision regret scores support this data because regrets were equally low across groups. The effect of a DA on adherence to choice of treatment remains unknown. We implemented the use of a simple DA written at a sixth to eighth grade reading level; however, little is known about the degree of detail that a DA requires to demonstrate an effect on the decision-making process. It is possible that had we provided a greater level of detail in our aid, we would have noticed a difference in mean scale scores of the DCS between groups. The purpose of the International Patient Decision Aid Standards (IPDAS) Collaboration is to enhance the quality and effectiveness of DAs by establishing an internationally approved set of criteria to determine the quality of patient DAs.12 The assessment of this aid based on IPDAS indicates that it meets 10 of 11 content criteria, 8 of 9 development process criteria, and 1 of 2 effectiveness criteria.7 Thus, the simple DA used in our study meets most of www.fpmrs.net

233

Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 4, July/August 2015

Brazell et al

TABLE 2. Differences in Overall Mean DCS Score and Subscores Subscore Uncertainty Informed Values clarity Support Effective decision Overall DCS score

SC

SC and DA

P

18.8 (23.3) 11.1 (15.2) 17.2 (20.1) 9.5 (13.9) 13.8 (18.3) 14.1 (16.1)

21.7 (21.4) 12.1 (12.7) 15.3 (15.5) 11.5 (14.4) 17.8 (19.1) 15.8 (13.9)

0.519 0.718 0.590 0.473 0.283 0.556

the IPDAS criteria for providing an evidence-informed framework to potential patients. Although we did not seek to determine if the addition of a DA increased patient knowledge of POP, prior studies on breast cancer, cystic fibrosis, and prostate cancer demonstrate improved patient knowledge as a result of implementing DAs.4,13,14 Thus, although DAs did not seem to decrease decisional conflict in our population, they may serve a role in increasing knowledge related to POP and treatment options. The knowledge obtained from DAs may even prove helpful to the informed consent process. One limitation of this study is the use of a nonvalidated DA, which does not include a discussion on treatment outcomes, only treatment choices. We implemented the use of a simple DA that is readily available on the internet. Although it is not validated, it does meet internationally approved criteria for quality and effectiveness.7 In addition, we did not verify whether or not subjects actually read the aids. Thus, it is plausible that we did not see a difference between groups because study participants assigned to the SC + DA group did not read the aid. Strengths of our study include its randomized design and implementation of validated questionnaires. No modifications were made to our counseling process as a result of this study. Areas for future study include validating this DA in a POP population and designing a knowledge test to determine the effectiveness of the DA. In conclusion, decision making for women with prolapse is not a problem with SC in this particular cohort of patients. However, DAs may play a role in increasing knowledge base and serve to supplement counseling when obtaining informed consent. ACKNOWLEDGMENTS The authors would like to acknowledge Barbara Conroy, Kathleen Morris, Michele Murdza, and Raisa Olivar. Without their assistance, this study would not have been possible.

234

www.fpmrs.net

REFERENCES 1. Wu JM, Hundley AF, Fulton RG, et al. Forecasting the prevalence of pelvic floor disorders in US women 2010 to 2050. Obstet Gynecol 2009;114:1278–1283. 2. Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979–1997. Am J Obstet Gynecol 2003;188:108–115. 3. O'Connor AM, Jacobsen MJ, Stacey D. An evidence-based approach to managing women's decisional conflict. J Obstet Gynecol Neonatal Nurs 2002;31:570–581. 4. Vandemheen KL, O'Connor AM, Bell SC, et al. Randomized trial of a decision aid for patients with cystic fibrosis considering lung transplantation. Am J Respir Crit Care Med 2009;180(8):761–768. 5. Whelan T, Levine M, Willan A, et al. Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial. JAMA 2004;292(4):435–441. 6. Stacey D, Bennett CL, Barry MJ, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2011;10:CD001431. 7. Ottawa Hospital Research Institute. Patient Decision Aids. Available at: https://www.healthwise.net/cochranedecisionaid/Content/ StdDocument.aspx?DOCHWID = av1031. Accessed December 1, 2013. 8. O'Connor Am. Validation of a decisional conflict scale. Med Decis Making 1995;15:25–30. 9. O'Connor AM. User Manual. Decisional Conflict Scale. Ottawa: Ottawa Research Hospital Institute. 1993 (Updated 2010). Available at: http://decisionaid.ohri.ca/docs/develop/User_Manuals/ UM_Decisional_Conflict.pdf. Accessed March 09, 2014. 10. O'Connor AM. User Manual. Decision Regret Scale. Ottawa: Ottawa Hospital Research Institute. 1996 (Modified 2003). Available at: http://decisionaid.ohri.ca/docs/develop/User_Manuals/ UM_Regret_Scale.pdf. Accessed June 04, 2014. 11. Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–17. 12. International Patient Decision Aid Standards (IPDAS) Collaboration. Available at: http://ipdas.ohri.ca/. Accessed December 15, 2013. 13. Waljee JF, Rogers M, Alderman AK. Decision aids and breast cancer: do they influence choice for surgery and knowledge of treatment options? J Clin Oncol 2007;25(9):1067–1073. 14. Lin GA, Aaronson DS, Knight SJ, et al. Patient decision aids for prostate cancer treatment: a systematic review of the literature. CA Cancer J Clin 2009;59:379–390.

© 2014 Wolters Kluwer Health, Inc. All rights reserved.

Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 4, July/August 2015

DA on Decision Making for POP Treatment

APPENDIX 1 Traditional DCS

1. I know which options are available to me. 2. I know the benefits of each option. 3. I know the risks and side effects of each option. 4. I am clear about which benefits matter most to me. 5. I am clear about which risks and side effects matter most to me. 6. I am clear about which is more important to me (the benefits or the risks and side effects). 7. I have enough support from others to make a choice. 8. I am choosing without pressure from others. 9. I have enough advice to make a choice. 10. I am clear about the best choice for me. 11. I feel sure about what to choose. 12. This decision is easy for me to make. 13. I feel I have made an informed choice. 14. My decision shows what is important to me. 15. I expect to stick to my decision. 16. I am satisfied with my decision.

© 2014 Wolters Kluwer Health, Inc. All rights reserved.

Strongly Agree

Agree

Neither Agree Nor Disagree

Disagree

Strongly Disagree

□ □ □ □ □ □

□ □ □ □ □ □

□ □ □ □ □ □

□ □ □ □ □ □

□ □ □ □ □ □

□ □ □ □ □ □ □ □ □ □

□ □ □ □ □ □ □ □ □ □

□ □ □ □ □ □ □ □ □ □

□ □ □ □ □ □ □ □ □ □

□ □ □ □ □ □ □ □ □ □

www.fpmrs.net

235

Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse.

The aim of this study was to evaluate if the addition of a decision aid (DA) decreases decisional conflict in women presenting for the management and ...
510KB Sizes 0 Downloads 5 Views