Introduction

Surgical preparedness includes optimization of patient understanding of procedural goals, risks, benefits, and expectations of the surgical recovery experience and therapeutic outcomes. Prepared patients have better reported condition-specific symptom scores, impressions of improvement, satisfaction, and lower complication rates up to 12 months postoperatively [1, 2]. A prospective trial of 79 women undergoing urogynecological surgery found that at 3 months postoperatively, prepared women were more likely to have improved Patient Global Impressions of Improvement (PGI-I) scores (68 vs 32%, p = 0.003), reported greater satisfaction with their surgery (77 vs 23%, p < 0.05), and had improved post-operative Pelvic Organ Prolapse Distress Inventory (POPDI; 0 [0–35], vs 8 [0–46], p = 0.02) and Urogenital Distress Inventory (UDI; 0 [0–33] vs 13 [0–67], p = 0.02) scores, whereas objective measures of cure did not differ by levels of preparedness [1]. Interventions to increase surgical preparedness have variable success in women with pelvic floor disorders (PFDs) [3,4,5,6,7].

Condition-specific tools to measure surgical preparedness have been developed for other surgical specialties [8]. Although the Preoperative Preparedness Questionnaire (PPQ) is a measure that is widely used to measure preparedness in women undergoing urogynecological surgery, it has not undergone psychometric evaluation and no other validated instruments to assess preparedness in this population exist [1]. Accurate measures of surgical preparedness are necessary to appropriately assess patient readiness for surgery as well as the quality of interventions to improve preparedness. We aimed to develop and validate a self-administered instrument to evaluate surgical preparedness in patients undergoing urogynecological surgery.

Materials and methods

Institutional review board approval was obtained prior to study initiation. This was a planned ancillary analysis of the Telephone Intervention to Increase Patient Preparedness for Surgery (TIPPS) trial [6]. Briefly, the TIPPS trial was a multicenter randomized trial assessing the impact of a pre-operative telehealth call on surgical preparedness for patients undergoing surgery for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). Enrollment was sequential and occurred at two urogynecology clinics associated with major tertiary referral teaching hospitals. Women over the age of 18 years who could read and speak English and who were scheduled to undergo surgery for SUI and/or POP were eligible for enrollment. Concomitant procedures were permitted. Exclusion criteria were inability to participate in a telehealth call (owing to dementia, a hearing disability, etc.) or surgery scheduled within 3 days or less from the enrollment visit. Enrollment and consent were completed during preoperative in-person visits.

Data gathered at enrollment included demographic characteristics and the Pelvic Floor Distress Inventory (PFDI-20), which includes both the POPDI and the UDI. Women were followed up in clinic 4–8 weeks after surgery and completed the PFDI-20, Decision Regret Scale (DRS), and Satisfaction with Decision Scale (SDS).

Candidate items for the Surgical Preparedness Assessment (SPA) were obtained from the PPQ [1] and a modified version of the Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ) [8]. The PPQ is an 11-item questionnaire with six-point Likert-type responses developed to assess preparedness for pelvic floor surgery [1]. Although the instrument has not undergone a formal validation process it has been used in multiple studies assessing interventions to increase surgical preparedness [3,4,5,6]. The PCSQ is a 23-item questionnaire with four-point Likert-type responses developed to assess preoperative preparedness for patients undergoing surgery for colorectal cancer [8]. The measure was originally validated in Swedish and then translated into English using a translation back translation methodology [8]. We modified the PCSQ to fit our population; Questions 20 and 21 were omitted because they were specific to patients with cancer. The content validity of the modified PCSQ was assessed to determine the degree to which the content of the modified version is an adequate reflection of the preparedness construct through cognitive interviews with topic experts and women who had undergone pelvic surgery. The PPQ and PCSQ were self-administered on paper in the preoperative holding area prior to surgery.

Basic psychometric analytical tools were used to evaluate the instrument [9]. Internal dimensional validity of domains was evaluated using principle factor analysis with Varimax rotation [10]. Retention of domains was determined by application of the Kaiser–Guttman rule (eigenvalues ≥ 1.0) and overall acceptance of domain structures was based on the measure of sampling adequacy (Kaiser–Meyer–Olkin test > 0.70). Item retention was based on the standard 0.60/0.40 difference in factor loading: items with a loading value greater than 0.60 but less than 0.40 [9,10,11,12,13]. Internal consistency was determined using a Cronbach’s alpha of greater than 0.70 as a cutoff for acceptable internal consistency [14]. Domain development was an iterative process amongst the research team to ensure that each domain was coherent and clinically useful. External measures used to evaluate construct validity were a priori identified as associated with preparedness or aspects of preparedness [1] and included the SDS [15], DRS [15], UDI [16] , and POPDI [17]. These variables were chosen because prepared women have been previously found to have greater postoperative satisfaction and improved scores on these outcome measures. Known group validity was assessed by comparing SPA values between the group that received a telehealth call vs routine counseling using Welch’s t test. The analytical dataset used for this validation is based on a per-protocol approach on the ancillary data from the TIPPS trial [6]. We adhered to the COSMIN Study Design Checklist for Patient-Reported Outcome Measurements [18]. Based on sample size recommendations for psychometric analysis, with a rule of thumb being 10 participants per item evaluated, this n = 132 is sufficient for psychometric evaluation of 11 items [19].

The response scales range from 1 to 6, with lower scores indicating a greater level of preparedness. The mean value of all the answered questions is calculated for each domain. Missing values are excluded. At least 50% of the questions in the domain must have a value so that the domain can be scored. If more than 50% of the questions are missing, then a score for that domain should not be calculated. Lower scores indicate greater surgical preparedness. Only total scores should be reported.

Results

As previously reported, a total of 150 women were enrolled for the study and 132 returned a completed survey (88% response rate). A total of 60 participants received a preoperative telehealth call by a single FPMRS attending or fellow surgeon who was part of the patient’s care team (Fig. 1).

Fig. 1
figure 1

Enrollment, randomization, and analysis of research participants. Patients were analyzed using a per-protocol analysis

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The groups did not differ in baseline characteristics except that the group without additional counseling was more likely to have a history of pelvic reconstructive surgery. The mean ± SD age of the sample was 57.9 ± 13.3 years. Ninety-two percent self-identified as white, and 27% self-identified as Hispanic, 64% had private insurance, 61% were married, and 61% had greater than a high school education. POP alone was diagnosed in 20%, SUI alone in 24%, and both POP and SUI in 56% (Table 1). A total of 28% of women underwent a sacrocolpopexy, 23% underwent a uterosacral ligament suspension, and 7% a colpocleisis [6].

Table 1 Baseline characteristics
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Three domains meeting a priori specified criteria emerged with 11 items. The following domains emerged: information needs; satisfaction and pain; and catheterization. Factor loadings for each domain were between 0.63 and 0.88 and met the criteria as outlined in the methods (Table 2). The internal consistency for each of the domains was acceptable to excellent, with alphas between 0.74 and 0.92 (Table 2).

Table 2 Final factor loadings and internal consistency of factors
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The mean score of the three domains comprising the SPA did not correlate with external measures including the SDS, DRS, UDI, and POPDI scores (all p > 0.05). Known group validity was supported with mean total SPA scores being significantly lower among women who received a telehealth call vs women who did not (1.30 ± 0.31 vs 1.50 ± 0.44, p = 0.002;Table 3).

Table 3 Known group validity: SPA scores with intervention and without intervention
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Discussion

We validated an 11-item SPA questionnaire with three domains that has acceptable content validity, internal consistency, and known group validity. Women who received an intervention to improve preparedness achieved higher scores on the SPA than those who did not. Our measure did not correlate with other measures of surgical outcomes included in our parent study.

Measuring surgical preparedness is important because evidence suggests that prepared patients might have better subjective outcomes [1]. Evaluating surgical preparedness allows for patient and surgeon alignment in perioperative expectations and highlights aspects of surgical preparedness that require additional attention. This tool can be used to identify patients who require further counseling in certain aspects of the surgical experience.

During the informed consent process a provider reviews diagnostic findings, therapeutic options, and surgical expectations. Despite this routine and seemingly informative process, patients continue to report misalignment between preoperative expectations and postoperative experiences [20]. A key component of preoperative counseling is patient understanding. A patient’s ability to understand the informed consent process is multifactorial and extends beyond health literacy [21]. In an observational study of 150 women seeking surgical treatment for PFDs, SDS scores were strongly associated with increased knowledge of the planned surgery. This study compared Informed Consent Questionnaire (ICQ-20) [22] scores between highly satisfied (n = 70, defined as highest possible level of satisfaction for all SDS items) and not highly satisfied (n = 77, defined as all other SDS scores) women and found significantly higher ICQ-20 scores amongst highly satisfied women (17.8 ± 3 vs 16.1 ± 77, p = 0.003). The relationship between preoperative satisfaction and knowledge persisted even after controlling for demographic and clinical variables including education level, health literacy, race/ethnicity, age, surgeon years since completing fellowship, diagnosis, surgery category, number of visits in the past 6 months, and number of days between informed consent discussion and survey. [23].

Surgical preparedness is different than informed consent and understanding in that it also captures perceived self-efficacy. Individuals with high self-efficacy have confidence in their ability to succeed with a task or achieve a desired outcome [24]. In 100 patients who underwent breast reconstructive surgery, higher levels of self-efficacy (as measured by the Modified Stanford Self-Efficacy Scale) were significantly related to high satisfaction with information (as measured by the information subscale of the BREAST-Q) when evaluated by multinomial logistic regression models (β = 1.03; 95% CI, 1.01 to 1.05) [25]. The SPA is a measure of both understanding and self-efficacy for women undergoing pelvic floor surgery.

Strengths of this study include the inclusion of both patients and providers in the development of our items, adequate sample size to test our items, and robust psychometric evaluation. Factors identified through cognitive interviews reflect concepts that patients report as being most important to their surgical experience. For example, the catheterization factor reflects what patients have reported as the worst aspect of their surgical experience, even considering catheterization a complication 1 year after surgery [26]. Weaknesses include a high proportion of white patients and our inability to include patients who do not speak English. The SPA is only validated in English and validating this instrument in other languages and cultures is important. Face validity was only determined for the modified version of the PCSQ; it was not determined for the PPQ. The SPA did not correlate with other commonly used measures of surgical success such as the SRS, DRS, and changes in the POPDI and UDI. This may be because we followed our patients up to only 8 weeks, and prior studies that found preparedness linked to outcomes followed patients for a longer time. In addition, our parent study did not capture other aspects of preparedness that may be an important part of the surgical experience, such as patient self-efficacy, physician communication, and trust in your provider.

In summary, the SPA is a more rigorously validated scale than those that are currently available to assess preoperative preparedness for women with Pelvic Floor Disorders. The SPA can be used both in clinical and research settings to assess patients’ preparedness for urogynecological surgery, identify patients who may require additional preoperative counseling, and evaluate the impact of tools that are aimed at improving preoperative preparedness. More rigorous psychometric testing of the SPA is also needed.