3. Materials and Methods
3.1. Study Design and Context
This study followed the Delphi-Dialogue Patients–Professionals (DDPP) framework to analyze concordance between patients and professionals regarding the quality of PM&R care for pelvic floor dysfunctions (PFD) in Spain. It was developed under SERMEF leadership with a defined coordinating group (research team) and external reviewers, including patient representatives from the Spanish Incontinence Association (ASIA) and PM&R clinicians with expertise in PFD.
The study was organized into a preparatory stage and two sequential analytical phases. The preparatory stage consisted of questionnaire development, expert review, and content review of the parallel patient and professional surveys, conducted between May 2022 and January 2023. Phase 1 consisted of survey deployment and comparative analysis of patient–professional alignment and divergence, conducted between February and April 2023. Phase 2 consisted of the formulation of recommendations from the Phase 1 findings and their subsequent feasibility assessment through a Real-Time Delphi-based process conducted in May 2024. This sequence allowed the study to move from instrument development, to empirical comparison of patient and professional perspectives, and finally to implementation-oriented prioritization of recommendations.
Figure 1.
Study workflow: preparatory stage, Phase 1 survey-based patient–professional comparison, and Phase 2 Real-Time Delphi-based feasibility assessment.
Figure 1.
Study workflow: preparatory stage, Phase 1 survey-based patient–professional comparison, and Phase 2 Real-Time Delphi-based feasibility assessment.
3.2. Survey Development and Structure
Two parallel online questionnaires, one for patients and one for professionals, were developed by the DDPP PFD research team composed of four senior PM&R physicians with expertise in pelvic floor dysfunction. Item content was reviewed by a panel involving 12 physiatrists with more than 10 years of experience in PFD and 15 patients from different autonomous communities across Spain from the Spanish Incontinence Association (ASIA). The review process focused on content relevance, face validity, clarity, patient comprehensibility, and equivalence between the patient and professional versions of the questionnaire. No formal psychometric validation or pilot study was conducted.
Both surveys shared a common structure:
A profile section collecting respondent characteristics.
A common core of 25 items addressing general aspects of PM&R care.
A PFD-specific module including 14 items addressing context-relevant aspects of pelvic floor rehabilitation care.
Items addressed domains reflected in the results presentation, including perceived support and involvement of rehabilitation teams, access barriers, adherence difficulties, information timing, self-management tools, and attitudes toward remote communication and digital support tools.
Equivalence between the patient and professional questionnaires was ensured by using parallel formulations addressing the same care component from each stakeholder perspective. Thus, each matched item referred to the same underlying aspect of pelvic floor rehabilitation care, while adapting the wording to the respondent’s role. For example, patients were asked about the information they had received, whereas professionals were asked about the information they usually provided. This approach enabled direct comparison of perceptions while preserving the experiential position of each group.
All evaluative items were rated on a six-point Likert scale, ranging from 1 = very low/poor to 6 = very high/excellent. The use of an even-numbered scale avoided a neutral midpoint and was intended to encourage respondents to express a directional assessment of each care component.
3.3. Participants and Recruitment
Two target populations were included in this study:
Patients: Adults (≥18 years) with pelvic floor dysfunction who were receiving or had previously received Physical Medicine and Rehabilitation (PM&R) care. Patients were recruited through national patient associations, with the collaboration of the Spanish Incontinence Association (ASIA), as well as through pelvic floor rehabilitation units across Spain. These recruitment pathways ensured inclusion of patients with diverse clinical profiles and care experiences within the national PM&R setting.
Professionals: Rehabilitation physicians (PM&R) and physiotherapists with clinical experience in pelvic floor dysfunction management. Recruitment was conducted nationwide through the SERMEF, ensuring broad representation across different healthcare settings.
Participation was voluntary and anonymous. All participants accessed the questionnaires via a secure online platform and provided informed consent prior to participation. Eligibility was confirmed through initial screening questions, and completion of the profile section was required before responding to the survey items.
The final survey sample included 225 patients with PFD and 164 rehabilitation professionals. Their demographic and professional characteristics are reported in the Results section.
3.4. Procedure
The DDPP PFD workflow followed a predefined sequence comprising questionnaire development and validation, survey deployment, descriptive and comparative analysis, recommendation formulation by the research team, and Real-Time Delphi-based feasibility assessment.
Survey responses were collected and aggregated to compare patient and professional perspectives on shared items and to identify gaps relevant for service redesign—particularly in access to specialized rehabilitation units, communication practices, adherence support, and the role of telemedicine/digital tools in follow-up.
3.5. Outcomes and Concordance Analysis
The primary analytical objective was to assess the degree of alignment and divergence between patients and professionals across shared survey domains.
Descriptive statistics were calculated for each item and group, including mean (μ), standard deviation (σ), and the proportion of high-agreement responses (A), defined as ratings in the upper categories of the Likert scale (scores 5–6). For calculation purposes, A was used as a proportion; values are displayed as percentages in the tables.
To operationalize divergence in a clinically interpretable manner, a composite divergence score (d) was applied. This score combined a standardized difference index (SDI) with the gap in high-agreement proportions (ΔA):
- SDI
= |μ_pat − μ_pro| / √[(σ²_pat + σ²_pro)/2]
- SDI
ΔA = |(A_pat − A_pro)| / min(A_pat, A_pro)
- d
= SDI × ΔA
The resulting divergence score, labelled here as d, should not be interpreted as Cohen’s d or as a validated statistical effect size. It was used as an exploratory operational score to support prioritization of patient–professional discrepancies by combining two complementary dimensions: distance in mean ratings and asymmetry in high-agreement responses. Higher values indicate greater divergence in both central tendency and strength of agreement. The divergence score should therefore be interpreted as an exploratory prioritization aid rather than a psychometric or inferential metric.
Because the ΔA component may amplify differences when one group shows low high-agreement proportions, the score was interpreted together with the underlying mean values, standard deviations, and high-agreement proportions, rather than as a standalone measure of clinical relevance.
Inferential p-values were not calculated because the study was not designed to test predefined hypotheses for each item. The analytical purpose was to identify and prioritize patterns of perceptual divergence between stakeholder groups. Given the exploratory and implementation-oriented purpose of the study, the analysis intentionally prioritized pattern identification over hypothesis testing. In addition, the ordinal structure of Likert responses and the large number of item-level comparisons supported the use of descriptive statistics and the operational divergence score as more appropriate tools for implementation-oriented interpretation.
Items were ranked according to the divergence score (d) to identify priority areas for improvement in pelvic floor rehabilitation care.
3.6. Delphi Stage for Recommendations
In May 2024, a structured modified Real-Time Delphi-based feasibility assessment was conducted to evaluate the implementation feasibility of the recommendations derived from Phase 1. The process integrated synchronous participation, real-time anonymized feedback, and within-session rescoring to support iterative refinement of feasibility ratings. The panel included 37 participants: 35 PM&R physicians with clinical experience in pelvic floor rehabilitation and two representatives from the Board of the Spanish Incontinence Association (ASIA) (
Table 1). Participants were selected purposively because of their clinical expertise, experience in pelvic floor care, or role in representing patient perspectives. The Delphi panel was not intended to reproduce the Phase 1 survey sample; rather, it functioned as an implementation-oriented assessment group. Some participants had previous knowledge of the DDPP process, but the feasibility assessment was conducted as an independent phase focused on recommendations rather than on individual survey responses.
Before rating the recommendations, participants received a structured summary of the Phase 1 findings, including descriptive comparisons between patients and professionals and the main areas of convergence and divergence. The research team then presented ten pre-formulated recommendations. These recommendations were not generated automatically from the highest-ranking items; instead, survey items were grouped interpretively according to their clinical meaning, care-delivery relevance, and conceptual proximity within the pelvic floor rehabilitation pathway.
The process was conducted synchronously using the SmartDelphi platform. Participants rated each recommendation on a six-point Likert scale ranging from very difficult to implement to quite easy to implement. Real-time anonymized group feedback was displayed after the initial rating, allowing participants to compare their individual assessment with the distribution of group responses. Participants were then allowed to reconsider and modify their scores during the same session. This process corresponds to a structured modified Real-Time Delphi approach integrating synchronous interaction, anonymized feedback, and within-session rescoring. The process was closed once all recommendations had been rated, group feedback had been reviewed, and no further score modifications were submitted within the allotted session time.
The purpose of this phase was not to generate new recommendations de novo, but to assess the perceived feasibility of implementing the pre-formulated recommendations. Feasibility ratings were summarized using mean, standard deviation, median, and interquartile range. These ratings were interpreted together with the mean divergence score associated with the linked survey items, allowing recommendations to be positioned according to two complementary criteria: the magnitude of the patient–professional gap and expected feasibility of implementation.
No predefined consensus threshold was applied; therefore, the results are interpreted as perceived feasibility ratings rather than formal consensus statements.
3.7. Ethics and Data Protection
This study was conducted in accordance with the principles of the Declaration of Helsinki and complied with all applicable Spanish and European regulations on biomedical research and data protection, including the Spanish Biomedical Research Law 14/2007, the Royal Decree 1090/2015, and the General Data Protection Regulation (GDPR, EU 2016/679).
In accordance with Articles 2 and 3 of Law 14/2007 and Article 2 of Royal Decree 1090/2015, formal CEIm approval was not required according to the applicable Spanish regulatory framework and the anonymous, non-interventional, survey-based nature of the study.
Survey data were collected anonymously through a secure web platform. No identifiable or sensitive information was stored, and all responses were aggregated for analysis to preserve confidentiality. During the Real-Time Delphi phase, responses remained fully anonymized, and only group-level feedback was shared to avoid any attribution of individual opinions.
The study protocol was internally reviewed and endorsed by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF). Recruitment of patients and professionals was supported by national hospital networks, ensuring compliance with ethical and legal standards for non-interventional survey-based research.