Abstract
Background:
We aimed to identify decision process measures associated with patient decisional regret regarding the decision to pursue elective colectomy or observation for diverticulitis.
Materials and methods:
This was a single-center cross-sectional survey study. We included adult patients treated for diverticulitis between 2014 and 2019 and excluded patients who required urgent or emergent colectomy. The primary outcome was regret regarding the decision to pursue elective surgery or observation for diverticulitis, measured using the Decision Regret Scale. We used multivariable linear regression to examine hypothesized predictors of decision regret, including decisional conflict (Decision Conflict Scale and its subscales), shared decision-making, and decision role concordance.
Results:
Of 923 eligible patients, 133 were included in the analysis. Patients had a median of five episodes of diverticulitis (interquartile range 3–8), occurring a median of 2 y (interquartile range 1–3) before survey administration. Thirty-eight patients (29%) underwent elective surgery for diverticulitis. Decision regret (Decision Regret Scale score ≥25) was present in 42 patients (32%). After controlling for surgery, gender, health status, and years since treatment, decision regret was associated with decisional conflict and inversely associated with values clarity, decision role concordance, shared decision-making, and feeling informed, supported, and effective in decision-making (all P < 0.001).
Conclusions:
Nearly one-third of survey respondents experienced regret regarding the decision between elective surgery and observation for diverticulitis. Decision regret may be reduced through efforts to improve patient knowledge, values clarity, role concordance, and shared decision-making.
Keywords: Diverticulitis, Surgery, Regret, Shared decision-making
Introduction
Diverticulitis accounts for more than 370,000 emergency room visits and 1.9 million outpatient visits per year in the United States.1 In the elective setting, treatment options for diverticulitis include observation and elective colectomy. Under an observation strategy, patients may experience smoldering symptoms2 or recurrent attacks.3 However, colectomy carries a substantial risk of perioperative complications, such as surgical site infection, anastomotic leak, and bleeding.4 Guidelines from the American Society of Colon and Rectal Surgeons state that the decision regarding observation or elective colectomy should be individualized.5 Decision-making is complex and should incorporate patient preferences, comorbidities, severity of symptoms, number of episodes, and impact on the quality of life.6 This high-stakes, high-complexity decision may leave diverticulitis patients vulnerable to treatment-related decision regret.
Decision regret is recognized as an important patient-reported outcome and component of high-quality decision-making.7,8 Regret is a negative emotion that arises from the belief that another choice would have resulted in a better outcome.9 A systematic review found that the prevalence of regret related to surgical treatment decisions is 14%,10 but this may be higher in decisions where there is more than one reasonable treatment option,9 such as diverticulitis. In other surgical populations, shared decision-making and decision role concordance are associated with decreased regret.10 The extent to which treatment decisions for diverticulitis are shared or incorporate patient values and preferences is not known.
This study aimed to identify decision process measures associated with decision regret among diverticulitis patients treated using an observation or elective colectomy strategy. We hypothesized that modifiable factors such as shared decision-making, decision role concordance, patient knowledge, and values clarity are associated with decision regret. The results will provide opportunities to optimize decision-making and decrease treatment regret.
Materials and methods
Patient identification
This was a cross-sectional survey study of English-speaking adult patients treated for diverticulitis at the University of Utah between June 1, 2014, and May 13, 2019. Patients with diverticulitis were identified using the University of Utah medical records system (Electronic Data Warehouse) using International Classification of Diseases (ICD) codes (ICD-9 562.11, 562.13; ICD-10 K57.2, K57.32, K57.33, K57.4, K57.52, K57.53, K57.8, K57.92, K57.93). We excluded patients who died before survey administration and those without valid email or postal addresses. We also excluded patients who underwent emergency surgery because these patients likely have different perceptions of whether there was a decision to be made regarding treatment.
Survey administration
Invitations to complete the electronic survey were sent to potential participants. Electronic invitations were resent to nonrespondents 2 wk and 6 wk later (referent to the study start date). To maximize response, we sent paper copies of the surveys with self-addressed and stamped envelopes to nonrespondents 4 and 8 wk after the initial invitation. To minimize the effect of regret on participation bias or survey answers, we introduced the study to patients as one “designed to understand your decision-making process about your diverticulitis treatment.” The Decision Regret Scale was administered after a number of questions about the patient’s diverticulitis history and sociodemographics. The survey is included as supplemental material.
Survey measures
Patients provided information regarding demographics, socioeconomic factors, medical history, family history, and diverticulitis symptoms and treatment. We verified patient-reported diverticulitis surgery using manual chart review. Complications were identified using our institutional National Surgical Quality Improvement Program11 data in patients it was available (n = 17) and manual chart review in those it was not (n = 21). Major complications were defined as Clavien-Dindo Grade III or IV events (a complication requiring procedural intervention or leading to failure of at least one organ system) or the need for multiple blood transfusions.12 Patients reported health status using the EQ-5D-3L.13 Predictors of interest were measured using the following validated instruments (Table 1): Shared Decision Making Questionnaire (SDM-Q-9),14 Gastrointestinal Quality of Life Index (GIQI-10),15 Decisional Conflict Scale (DCS),11 and Control Preferences Scale (CPS).12 The CPS is a single item instrument with five answer choices. We categorized CPS responses as follows: “Patient-led” (score 1–2), “Shared” (score 3), and “Physician-led” (score 4–5). Decision role concordance was considered present when the experienced role in decision-making matched the desired role in decision-making.16 Decision regret regarding the decision to pursue observation or surgery for diverticulitis (primary outcome) was measured using the Decision Regret Scale (DRS).9 A score of ≥25 on the DRS indicates clinically relevant decisional regret.17,18 All questions about decision-making were directed specifically to the decision between elective colectomy or observation.
Table 1 –
Characteristics of instruments used in the study.
| Measurement | Instrument | Score range | Higher score indicates |
|---|---|---|---|
| Decision regret | DRS | 0–100 | Increased regret |
| Shared decision-making | Shared decision-making questionnaire (SDM-Q-9) | 0–100 | Greater shared decision-making |
| Decisional conflict | DCS | 0–100 | Greater decisional conflict |
| Feeling informed | DCS: informed subscale | 0–100 | Feeling less informed |
| Values clarity | DCS: values clarity subscale | 0–100 | Decreased clarity about values |
| Support in decision-making | DCS: support subscale | 0–100 | Decreased support |
| Uncertainty | DCS: uncertainty subscale | 0–100 | Increased uncertainty |
| Effectiveness of decision | DCS: effective decision subscale | 0–100 | Decreased effectiveness |
| GI quality of life | Gastrointestinal quality of life index (GIQLI-10) | 0–40 | Better quality of life |
Statistical analysis
Patient characteristics are presented using descriptive statistics for the full cohort and stratified by clinically significant decision regret (DRS score ≥ 25).17 Bivariate analyses were performed using chi-square, Fisher’s exact, and exact Wilcoxon rank-sum tests, as appropriate. The CPS and EQ-5D-3L were not scored if any item was unanswered. The remainder of the validated questionnaires were not scored if there were more than two missing items.
Based on existing literature, we hypothesized that decision regret would be associated with shared decision-making,10 role concordance,19 quality of life,17 and decisional conflict and its subscales (Informed, Values Clarity, Support, Uncertain, and Effective Decision).17,20 Because of the collinearity of the predictors, we performed a separate univariable and multivariable linear regression model for each hypothesized predictor. Multivariable models adjusted for patient factors with a P < 0.06 on bivariate analysis: age, treatment type (elective surgery versus observation), gender, and health status. We additionally adjusted the models for years since treatment for diverticulitis based on two systematic reviews demonstrating the importance of time in patient-reported decision regret.10,17 We standardized the decision regret predictor scores to have mean of 0 and standard deviation (SD) of 1 to facilitate comparison of the coefficients. The choice to use linear regression was made after considering generalized linear regression examining several possible outcome models. Linear regression provided the best or similar fit according to several metrics for model fit, including qq plots, residual versus fitted plots, and an assessment of outliers.
Survey respondents and nonrespondents were compared on several factors available in the medical record, including gender, age, race, ethnicity, and treatment type. The values for treatment type, race, and ethnicity are different from the estimates in the primary analyses described previously because the primary analyses are based on patient report as opposed to medical record data. We used chi-squared, Fisher’s exact, and Wilcoxon rank-sum tests as appropriate. For all analyses, statistical significance was assessed at the 0.05 level. Analyses were conducted in R v.3.6.1 (R Foundation for Statistical Computing, Vienna, Austria, https://www.R-project.org).
Ethical considerations
The University of Utah Institutional Review Board approved the study (IRB_00117503), and a waiver of informed consent was obtained.
Results
Participant characteristics
Of 923 potential participants, 149 completed the survey (16.1% response rate). Sixteen were excluded because of missing or incomplete Decision Regret Scale responses, resulting in a total sample of 133 patients. A minority of patients completed the survey using the paper format (n = 11). Table 2 shows patient demographic and diverticulitis data. The majority (91.0%) did not report major medical problems at the time they were treated for their diverticulitis. 12 (9%) had diabetes mellitus, 6 (4.5%) were on supplemental home oxygen, 6 (4.5%) were on blood thinners, 4 (3%) were on steroids, 3 (2.3%) were on chemotherapy, 2 (1.5%) had a previous myocardial infarction, and 1 (0.8%) was on dialysis. For each of the previously mentioned medical problems, there were no significant differences between those with and without decision regret, P ≥ 0.19 for all comparisons (data not shown). Of the 38 patients who had surgery for diverticulitis, there was one major surgical complication, anastomotic leak requiring reoperation.
Table 2 –
Patient characteristics of the total sample (first column) entire sample and then stratified by the presence of decision regret (DRS score ≥25).
| Characteristic | Decision regret |
P value‡ | |
|---|---|---|---|
| Present (n = 42) | Absent (n = 91) | ||
| Age* (y) | 54.0 (44.2, 65.8) | 62.0 (52.5, 67.0) | 0.06 |
| Gender | 0.039 | ||
| Male | 15 (35.7%) | 50 (54.9%) | |
| Female | 27 (64.3%) | 41 (45.1%) | |
| Race | 0.55 | ||
| White | 38 (90.5%) | 86 (94.5%) | |
| Asian | 1 (2.4%) | 1 (1.1%) | |
| Native Hawaiian or other Pacific Islander | 1 (2.4%) | 0 (0.0%) | |
| Other | 1 (2.4%) | 2 (2.2%) | |
| Prefer not to answer | 1 (2.4%) | 2 (2.2%) | |
| Ethnicity | 0.37 | ||
| Hispanic or Latino | 0 (0.0%) | 3 (3.7%) | |
| Non-Hispanic or Latino | 35 (92.1%) | 75 (92.6%) | |
| Prefer not to answer | 3 (7.9%) | 3 (3.7%) | |
| Surgical treatment | 0.013 | ||
| No | 36 (85.7%) | 59 (64.8%) | |
| Yes | 6 (14.3%) | 32 (35.2%) | |
| Number of episodes | 4.0 (3.0, 5.0) | 5.0 (3.0, 10.0) | 0.23 |
| Years since treated | 2.0 (1.2, 2.8) | 2.1 (1.2, 3.3) | 0.52 |
| Highest level of care | 1.00 | ||
| Outpatient | 11 (27.5%) | 25 (27.8%) | |
| Emergency department | 11 (27.5%) | 26 (28.9%) | |
| Hospitalization | 18 (45.0%) | 39 (43.3%) | |
| Most recent provider | 0.48 | ||
| Primary care physician | 14 (33.3%) | 21 (23.1%) | |
| Gastroenterologist | 13 (31%) | 27 (29.7%) | |
| Surgeon | 11 (26.2%) | 35 (38.5%) | |
| Other | 4 (9.5%) | 8 (8.8%) | |
| Smoldering symptoms | 0.11 | ||
| Yes | 24 (58.5%) | 66 (72.5%) | |
| No | 17 (41.5%) | 25 (27.5%) | |
| Major medical problem† | 1.00 | ||
| Yes | 4 (9.5%) | 8 (8.8%) | |
| No | 38 (90.5%) | 83 (91.2%) | |
| EQ5D3L index | 0.8 (0.7, 0.8) | 0.8 (0.8, 1.0) | <0.001 |
| EQ5D3L visual analog scale | 66.0 (50.0, 76.5) | 80.0 (71.0, 86.5) | <0.001 |
Missing values by group: ethnicity: 14, marital status: 1, treatment options: 1, smoldering symptoms: 1, EQ-5D Index: 1, years since treated: 4; percentages exclude missing values from the denominator.
Age (years) at last episode of diverticulitis.
Major medical problem includes history of myocardial infarction, use of home oxygen, dialysis, diabetes, cirrhosis, organ transplant, steroids, blood thinners, chemotherapy.
For the comparison between decision regret present versus absent
Role concordance
As shown in Table 3, patients largely reported patient-led or shared decision-making when it came to treatment for diverticulitis. However, physician-led decision-making was experienced by 27.1%, but only desired by 8.7%. In our sample, 26% of patients did not achieve role concordance. Of these, 26 (81.2%) desired greater participation and 6 (16.7%) desired less involvement. Decision role concordance was less common among patients with decision regret (50.0% versus 83.2%; P < 0.001). Of those not achieving decision role concordance, a preference for a greater role in decision-making was associated with decision regret (P < 0.001), but preferring a lesser role was not (P = 0.21).
Table 3 –
Decision role outcomes of the total sample (first column) and then stratified by the presence of decision regret (DRS score ≥25).
| Characteristic | Total sample |
Decision regret |
P value | |
|---|---|---|---|---|
| (n = 133) | Present (n = 42) | Absent (n = 91) | ||
| Experienced role in decision-making | 0.043 | |||
| Patient-led | 47 (36.4%) | 10 (26.3%) | 37 (40.7%) | |
| Shared | 47 (36.4%) | 12 (31.6%) | 35 (38.5%) | |
| Physician-led | 35 (27.1%) | 16 (42.1%) | 19 (20.9%) | |
| Desired role in decision-making | 0.69 | |||
| Patient-led | 57 (45.2%) | 17 (50.0%) | 40 (44.9%) | |
| Shared | 58 (46.0%) | 18 (48.7%) | 40 (44.9%) | |
| Physician-led | 11 (8.7%) | 2 (5.4%) | 9 (10.1%) | |
| Decision role concordance | <0.001 | |||
| Yes | 91 (74.0%) | 17 (50.0%) | 74 (83.2%) | |
| No | 32 (26.0%) | 17 (50.0%) | 15 (16.9%) | |
| Preferred greater role in decision-making | 26 (21.1%) | 14 (33.3%) | 12 (13.2%) | 0.001 |
| Preferred lesser role in decision-making | 6 (4.9%) | 3 (7.1%) | 3 (3.3%) | 0.21 |
Missing values by group: experienced role in decision-making: 4, desired role in decision-making: 7; percentages exclude missing values from the denominator.
Decision regret
The median DRS score was 10 (interquartile range 0–25). Seventy-six patients (57.1%) reported at least some decision regret (score >0, as reported by Good et al.21). A total of 42 patients (31.5%) had significant decision regret as measured by a DRS score of ≥25.
Multivariate analysis for predictors of decision regret
After standardizing instrument scores as described in the Methods section, we performed separate multivariate linear regression models to evaluate each hypothesized predictor of decision regret (Table 4). Model coefficients represent the change in DRS score associated with a change in the predictor score by 1 SD. For example, every 1 SD increase in the Decisional Conflict Score corresponds to a 13-point increase in the Decision Regret Score (95% confidence interval: 10–16; P < 0.001) after adjusting for gender, years since treatment for diverticulitis, health status (EQ-5D-3L), and whether one had elective surgery for diverticulitis. For all models, the associated P values were <0.001. Thus, increasing decision regret is significantly associated with increasing decisional conflict, feeling less informed, decreased values clarity, less support, less effective decision-making, less shared decision-making, worse GI-related quality of life, and decision role nonconcordance.
Table 4 –
Multivariable analysis to identify predictors of decision regret among patients treated for diverticulitis.
| Instrument | Total sample mean (SD) | Unadjusted |
Adjusted* |
|---|---|---|---|
| Estimate (95% CI) | Estimate (95% CI) | ||
| DCS total | 27 (27) | 15 (12, 17) | 13 (10, 16) |
| DCS—informed subscale | 31 (31) | 14 (11, 17) | 12 (10, 15) |
| DCS—values clarity subscale | 28 (30) | 13 (11, 16) | 12 (9, 14) |
| DCS—support subscale | 25 (27) | 13 (10, 16) | 12 (9, 15) |
| DCS—effective decision subscale | 23 (26) | 15 (12, 17) | 13 (11, 16) |
| SDM-Q9 shared decision-making | 56 (32) | −8 (−11, −5) | −6 (−9, −3) |
| GIQLI GI quality of life | 28 (7) | −11 (−14, −7) | −9 (−13, −5) |
| Decision role concordance, n (%) | |||
| No | 32 (26%) | — | — |
| Yes | 91 (74%) | −17 (−24, −9) | −13 (−20, −5) |
Each instrument was analyzed separately in its own model. For all estimates, P value was <0.001.
Each model used a linear regression technique with Decision Regret Scale score as the outcome.
Adjusted for age, gender, years since treatment for diverticulitis, health status (EQ-5D-3L), and treatment type (surgery versus observation). Higher scores on DCS and its subscales indicate a worse measured state. Lower scores on SDM-Q9 and GIQLI indicate less shared decision-making and GI-related quality of life, respectively.
Nonresponse analysis
We next compared the characteristics of survey respondents and nonrespondents (Table 5). Age and treatment type were similar between groups; however, respondents were more likely to be male, Caucasian, and non-Hispanic, compared with nonrespondents. The proportion of patients undergoing surgery for diverticulitis in the nonresponse analysis does not match that in the analysis of patient characteristics in Table 1 because the information in Table 1 was obtained by patient self-report, whereas the information in Table 5 was obtained by information extracted from the medical record.
Table 5 –
Characteristics of respondents and nonrespondents.
| Variable | Respondents (n = 133) | Nonrespondents (n = 774) | P value |
|---|---|---|---|
| Age (years) at index diverticulitis: median (IQR) | 59.0 (49.8, 66.0) | 61.0 (50.0, 71.0) | 0.07 |
| Gender | 0.06 | ||
| Female | 68 (51.5%) | 467 (60.3%) | - |
| Male | 65 (48.9%) | 307 (39.7%) | - |
| Race | 0.034 | ||
| White or Caucasian | 127 (96.2%) | 688 (88.9%) | - |
| American Indian and Alaska Native | 0 (0%) | 8 (1%) | - |
| Asian | 1 (0.8%) | 4 (0.5%) | - |
| Black or African American | 0 (0%) | 7 (0.9%) | - |
| Choose not to disclose | 3 (2.2%) | 5 (0.6%) | - |
| Native Hawaiian and other Pacific Islander | 0 (0%) | 6 (0.8%) | - |
| Other | 2 (1.6%) | 56 (7.2%) | - |
| Ethnicity | <0.001 | ||
| Choose not to disclose | 4 (3.0%) | 14 (1.8%) | - |
| Hispanic/Latino | 1 (0.8%) | 67 (8.7%) | - |
| Not Hispanic/Latino | 128 (96.2%) | 693 (89.5%) | - |
| Treatment | 0.29 | ||
| Percutaneous Drainage | 5 (3.8%) | 22 (2.8%) | - |
| Elective surgery | 10 (7.5%) | 32 (4.1%) | - |
| Conservative | 119 (89.5%) | 720 (93%) | - |
Discussion
We performed a cross-sectional survey study of decision regret regarding the decision to pursue elective colectomy or observation for diverticulitis. Significant decision regret was reported by approximately one in three survey respondents, and almost two in three reported any level of decision regret. We identified a number of modifiable decision-making factors, including feeling informed, having clear values, shared decision-making, and role concordance that were protective against decision regret. These modifiable factors remained significant after adjusting for patient characteristics, including age, health status, gender, time since treatment, and treatment type (observation or elective surgery). Treatment decision-making for diverticulitis is complex, and our results suggest that patient education and engagement could be targets for future efforts to improve patient-reported outcomes.
Decision regret was present in 32% of our study population, a proportion more than two-fold greater than other populations. A systematic review of decision regret in patients making other surgical decisions showed a prevalence of decision regret of only 14%.10 Another systematic review analyzed patients making medical or surgical decisions and found that decision regret was present in only 9%.17 To our knowledge, there are no prior studies of decision regret in diverticulitis patients. Decision regret is a complex phenomenon and can occur as a result of the decision-making process, decision-making role, option selected, or the outcome of treatment.7 The high rates of decision regret in diverticulitis patients may be in part because of the high stakes nature of the decision to pursue observation or surgery. Under an observation strategy, 38% of patients have ongoing smoldering symptoms,2 and 22%-36% have recurrent episodes.22,23 Under a surgical strategy, 14–23% of patients experience postoperative complications,4,24 and 5%-9% have recurrent diverticulitis.25–28 When patients experience an adverse treatment outcome, they are more likely to experience regret.18 In addition, GI-related quality of life was also associated with decision regret, underscoring the importance of developing treatment strategies that maximize patient-reported outcomes, as has been promoted in the DIRECT29 and ongoing COSMID30 trials.
Complication-related regret may be attenuated if the patient is actively engaged, fully informed, and a treatment decision is made that reflects patient values and preferences. In the present study, we found that decision regret was less common in patients who experienced shared decision-making and role concordance, indicating that improving the decision-making process could result in decreasing decision regret regardless of patient outcome. Specifically, we found that decision regret was less common in patients who felt informed, had clear values, and were supported in decision-making. These modifiable process-related measures are attractive targets for a decision support tool. Future efforts to understand the drivers of decision regret and patient expectations are needed.
Decision support tools, such as patient decision aids, are patient engagement tools that provide evidence-based patient education as well as exercises that clarify values.31 Decision aids improve knowledge, values clarity, engagement in decision-making, and satisfaction32 and therefore may be effective in supporting decision-making and decreasing decision regret. However, despite using decision aids, physicians struggle to elicit patient goals and integrate them into treatment decisions, and the opportunity for patient-centered decision-making may be missed.33 It is therefore not surprising that some studies show improvement in decision regret with decision aids,34 and others do not.35–39 A successful solution to decision regret will require engagement from both the patient and the physician and a better understanding of the barriers that each face during the decision-making process.
Although our study has a number of strengths, we recognize the possibility of response and recall bias. We attempted to maximize response by using a multimodal (electronic and paper-based) approach but ultimately achieved a 16% response rate. In addition, responders were more likely to be male, Caucasian, and non-Hispanic. The single-center design, response rate, and differences in characteristics between responders and nonresponders limit our ability to generalize these findings to broader populations. In addition, the study design required asking patients to report their experiences about decision-making retrospectively, and therefore, responses may be subject to recall bias.
Conclusions
Approximately one-third of diverticulitis patients in our cohort experienced regret regarding the decision to pursue surgery or observation, a rate much higher than reported in other populations. Decision regret is associated with modifiable decision process factors, including knowledge, values clarity, role concordance, and shared decision-making. Future research should confirm these findings in larger, representative populations and evaluate the impact of decision support tools that target patient education, engagement, support, and values clarity on decision regret.
Supplementary Material
Acknowledgment
The authors would like to thank Ryan Butcher, MBA, Medical Informaticist from the University of Utah Data Science Service from the University of Utah Electronic Data Warehouse for his contributions to data acquisition and programming and Jordan Esplin, BS, for her contributions to data collection.
This investigation was supported by the University of Utah Study Design and Biostatistics Center, with funding in part from the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1TR002538.
Footnotes
This work was accepted as a 2020 ASCRS Podium Original Contribution Submission, Quick Shot of Distinction QS441.
Disclosure
The authors have no relevant financial relationships to disclose.
Supplementary data
Supplementary data to this article can be found online at https://doi.org/10.1016/j.jss.2020.12.019.
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