Implementation and Feasibility of the VALORA Checklist for Structured Anamnesis in Oral Contraceptive Counseling in Spain: Results from a Survey-Based Pilot Study

Introduction

Oral contraceptives (OCs), when used with an informed and personalized approach, can help women prevent unintended pregnancies and exercise autonomy over their reproductive health. ¹ Despite their widespread use, ² prescribing requires a thorough clinical assessment to ensure safety and efficacy, particularly given the variability in individual risk factors and clinical practice patterns.

Combined oral contraceptives (COCs), containing estrogen and progestin, are the most commonly used OC method because of their high efficacy and additional noncontraceptive benefits. However, COCs are contraindicated in some cases because of an increased cardiovascular risk, including risk of venous thromboembolism (VTE), ³ which is influenced by factors such as age, body mass index (BMI), smoking, migraine, and the puerperium.^4–8 Nevertheless, this risk is higher during pregnancy than among COC users. ⁹ On the other hand, progestin-only pills (POPs) are an alternative with a favorable cardiovascular safety profile.^10,11

Although the World Health Organization (WHO) provides evidence-based medical eligibility criteria for contraceptive use, these recommendations must be adapted to address the specific needs and clinical practices of each population. ² In Spain, the use of POPs is low relative to that of COCs compared with neighbouring countries, despite both options being widely available. Fourth-generation POPs, such as drospirenone, have comparable contraceptive efficacy to COCs and a good tolerability profile.^12–20 In 2024, only 1% of women reported using POPs compared with 18% using COCs, a pattern that has remained stable compared with previous national contraceptive surveys.^21–23 This discrepancy between the broad medical eligibility of POPs and their limited use, in the context of potentially underrecognized emerging risk factors, highlights the need for improved counseling and individualized method selection based on clinical risk profiles and patient preferences. In this line, previous studies pointed to a high rate of COCs use in women with a medical contraindication. ²⁴ Structured anamnesis (i.e., systematic medical history-taking) is essential to guiding safe and convenient contraceptive choices; however, real-world practice shows variability in the systematic assessment of risk factors, which may lead to heterogeneous prescribing decisions.

To address this gap, we have previously developed a checklist as a practical tool to standardize anamnesis prior to prescribing OCs, ²⁵ using a design thinking. The checklist, now called VALORA checklist—from the Spanish verb “valorar” (to assess or evaluate), reflecting its core purpose of systematic clinical risk factor assessment—includes items divided into five categories: (1) general characteristics (reason, age, body mass index [BMI], smoking, blood pressure, puerperium), (2) personal medical history (thrombosis, heart disease or stroke, breast cancer), (3) family history (thrombosis, heart disease or stroke, breast cancer), (4) migraine (with/without aura), and (5) other relevant conditions (hyperlipidemia, diabetes, cholelithiasis, other liver disease, and alcohol/drug intake). By ensuring a consistent anamnesis, this checklist could facilitate safer, evidence-based contraceptive counseling, reducing variability in routine clinical practice, and support patient-centred decision-making in contraceptive care. ²⁵

The aim of this study was to evaluate the implementation of the VALORA checklist during contraceptive counseling, following training on the checklist in a proof-of-concept pilot study.

Methods

Results

HCPs characteristics

A total of 30 HCPs participated in the study. Participants’ sociodemographic characteristics are presented in Table 1. The mean (SD) age was 39.4 (6.8) years. Most participants were female (66.7%) and Spanish (93.3%). The majority were gynecologists (90%), whereas 10% were primary care specialists. Nearly half (43.3%) worked exclusively in public centers within the Spanish National Health System (SNS), and 23.3% worked in both public and private settings. Approximately half (53.3%) reported having a family planning unit at their workplace.

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Table 1.

Health Care Professionals Sociodemographic Characteristics

	N = 30
Sex, female, n (%)	20 (66.7)
Age, years, mean (SD)	39.4 (6.8)
Nationality, Spanish, n (%)	28 (93.3)
Speciality, n (%)
Gynecologist	27 (90.0)
Primary care	3 (10.0)
Type of center, n (%)
Public	13 (43.3)
Private	10 (33.3)
Public and private	7 (23.3)
Family planning unit available, yes, n (%)	16 (53.3)
Tools used for OC prescription, n (%)
WHO criteria	17 (56.7)
SEC criteria	17 (56.7)
Mobile applications	8 (26.7)
Scientific society checklist	8 (26.7)
Internal workplace checklist	6 (20.0)
Self-developed checklist	6 (20.0)
None	4 (13.3)
Shared decision tool	2 (6.7)
FSRH criteria	1 (3.3)

FSRH, Faculty of Sexual and Reproductive Health care; n, number of participants; N, total number of participants; OC, oral contraceptive; SD, standard deviation; SEC, Sociedad Española de Contracepción (Spanish Society of Contraception); WHO, World Health Organization.

The HCPs reported a mean (SD) of 13.1 (6.7) years of experience managing women seeking OC counseling. According to the participants, a mean (SD) of 298.0 (136.1) women attended their consultations each month. Of these, 40.5% (26.9) sought contraceptive counseling of any type, while 45.8% (24.1) of those seeking contraception specifically requested OCs. Only 3.8% (6.2) of consultations involved requests for voluntary pregnancy termination. The WHO criteria were the most commonly used prescribing support tool, selected by 56.7% of the HCPs participating in the study.

User profile

Most women seeking OC advice were aged 25–39 years, and a mean of 61% were Spanish (Table 2). The participants recommended COC to a mean of 47.3% (21.5) of users, with a mean (SD) age of 28.1 (5.4) years. POPs were recommended to a mean of 40.5% (19) of users, and nonoral contraceptives were recommended to 32.3% (21.7) of users. In both cases, the mean user age was ∼35 years (Fig. 1). Because each percentage represents independent HCP reports and some women receive recommendations for multiple methods before selecting one, responses could exceed 100%. VTE risk factors were present in a mean of 17.3% (17.9) of women receiving hormonal contraceptives.

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FIG. 1.

Use of hormonal contraceptive methods. Mean percentage of users and mean age by contraceptive method: combined oral contraceptives (COC), progestin-only pills (POP), and nonoral hormonal methods. Mean and standard deviation (SD) are represented.

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Table 2.

Users Sociodemographic Characteristics

	N = 30
Age, mean percentage (SD)
≤19 years	9.3 (6.3)
20–24 years	16.6 (7.3)
25–29 years	18.3 (6.2)
30–34 years	18.0 (5.7)
35–39 years	18.3 (6.6)
40–44 years	12.0 (4.9)
≥45 years	7.5 (6.6)
Nationality, mean percentage (SD)
Spanish	61.0 (20.6)
Not Spanish	35.3 (18.4)
Unknown	3.7 (18.3)

N, total number of participants.

The most common reason for seeking advice was contraception, reported for a mean of 51% (21.4) of users, followed by menstrual cycle regulation in 20.5% (14.8) (Fig. 2).

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FIG. 2.

Reasons for seeking contraceptive advice. Distribution of reported reasons for seeking contraceptive advice. Mean and SD are represented.

Checklist implementation

Before training on the VALORA checklist, HCPs reported using a checklist during contraceptive counseling anamnesis in a mean of 54.3% (46.5) of consultations. This percentage increased to 78.2% (31.3) post training. The mean change was 23.9% points (55.2). Of the 30 HCPs, 53.3% (n = 16) reported an increase in the proportion of consultations in which a checklist was used post training, regardless of prior checklist use, indicating individual heterogeneity in response to training. However, response distribution was broad, particularly at baseline. The median (IQR) checklist use was 65% (3–100) pretraining and 92.5% (70–100) posttraining, representing a statistically significant increase (p = 0.031) (Fig. 3).

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FIG. 3.

Implementation of checklists for anamnesis. Comparison of the distribution of answers regarding the implementation of a checklist before and after training on the VALORA checklist. Minimum, Q1, median, Q3 and maximum are represented. HCPs, health care professionals.

Regarding the checklist items (Fig. 4), some were already highly implemented at baseline according to the HCPs, with mean values close to 100% items such as reason for treatment, age, smoking status, puerperium, personal history of thrombosis, heart disease or stroke, breast cancer, and migraine. These items were nearly universal after training. On the other hand, those items with lower initial implementation showed improvement after training, including blood pressure, family history, cholelithiasis, and liver diseases. However, this improvement was considered significant only for the family history of thrombosis. Before training, the median (IQR) score was 100 (50–100) and after training it increased to 100 (80–100) (p = 0.005), while the mean shifted from 70.2 (41.2) to 86.3 (24.5). The changes in dispersion and distribution of all items are presented in Supplementary Table S1.

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FIG. 4.

Implementation of items of the VALORA checklist. Comparison of the distribution of answers regarding the implementation of each item of the VALORA checklist before and after training on the VALORA checklist. Median and Q1–Q3 are represented. BMI, body mass index; F.H.: family history; P.H., personal history.

Discussion

This study evaluated the impact of implementing a structured tool for clinical anamnesis for OC prescription, the VALORA checklist, in routine clinical practice following a training program. The implementation of a structured anamnesis can improve the consistency and completeness of risk factor assessment in contraceptive counseling. Our results show an improvement in the use of a structured approach and a significant increase in family history of thrombosis assessment, a domain usually underassessed. These results reinforce the need for tools to bridge the gap between guideline recommendations and routine clinical practice.

The WHO Medical Eligibility Criteria remain the gold standard: They classify eligibility by contraceptive method and clinical condition into four categories, ranging from “no restriction” to “should not be used.” Therefore, the initial anamnesis must capture the conditions and risk factors that change a method’s safety profile. ² In parallel, digital decision-support tools for method choice have become more common. Their value for the anamnesis is to strengthen the preferences component and help the user to arrive better prepared for shared decision-making, while still requiring discussion of medical history. ²⁶ This complementarity aligns with evidence on counseling: Cavallaro et al. found that interventions targeting women who were initiating a method with structured counseling, tended to show positive effects on continuation. ²⁷ Prescribing trends in the United Kingdom also provide practice context for what initiation interviews need to handle and the importance of counseling. ²⁸

Nevertheless, clinician adherence to guidelines and comprehensive risk factor evaluation remain inconsistent.^2,29 The underassessment of critical domains, such as personal or family history of VTE, uncontrolled hypertension, and hepatic disorders, has been linked to adverse outcomes, inappropriate method selection, and disparities in contraceptive safety.^3,30 The structured approach followed by the VALORA checklist was designed to address these gaps, including items such as reason for treatment, age, BMI, smoking status, blood pressure, postpartum status, personal and family history of diseases, various comorbidities, and substance use, all of which reflect the core domains identified in international guidelines. ²⁵

The participating HCPs in our study represent a typical cross-section of Spanish contraceptive care providers, predominantly female, working as gynecologists within the SNS. Although many prescriptions of contraceptives are continued by primary care physicians, specialist-driven contraceptive counseling remains common practice. The high volume of consultations for contraceptive advice, particularly for OC requests, underscores the ongoing demand for reproductive health services. This pattern aligns with recent national surveys of contraceptive use in Spain.^21–23

The demographic profile and contraceptive distribution are also consistent with national patterns, showing that women aged 25–39 years constitute the predominant group seeking OC advice. The balanced recommendation of COCs and POPs, with mean user ages centred in the late 20s and 30s, reflects current clinical practice guidelines that emphasize personalized method selection according to age, risk factors, and preferences. However, these results diverge from the most recent national usage survey, which reported substantially lower POP implementation rates. ²³ Several factors may explain these differences. First, methodological differences in sampling may have influenced the observed prevalence estimates. Second, the results may reflect a temporal shift in prescribing practices toward increased POP recommendations, consistent with trends reported in other countries. ²⁸ Alternatively, the differences may arise from overestimation in self-reported prescription practices or from discordance between HCP-reported recommendations and actual contraceptive utilization patterns in real-world clinical settings.

Risk factors for VTE were reported to be present in nearly one fifth of women receiving hormonal contraceptive counseling. This prevalence appears substantially lower than expected based on epidemiological data, suggesting potential underrecognition of risk factors during baseline anamnesis, highlighting the rationale for the VALORA checklist intervention to improve systematic risk factor identification, as inadequate screening may expose women to preventable adverse events. ³¹ Additionally, the predominance of contraception and menstrual cycle regulation as reasons for consultation is consistent with the multifaceted benefits sought by potential users and supports the relevance of comprehensive counseling aligned with both medical and lifestyle priorities.

Training on the VALORA checklist was associated with an increase in the proportion of consultations in which any checklist was used (median 65% pretraining to 92.5% posttraining, p = 0.031). However, causal relationships cannot be established without a control group. Moreover, the wide baseline variation in assessment practices demonstrated initial heterogeneity, whereas posttraining convergence toward higher adoption rates suggests that the VALORA checklist reduced practice variability. The finding that 50% of adopters used VALORA alongside existing tools rather than replacing them suggests that it was perceived as complementary, although the reasons why 23.3% did not implement the checklist despite training were not assessed. The improvements observed align with evidence from previous studies demonstrating that clinical decisión-support tools promote systematic counseling through consideration of all relevant factors, contributing to safer and more individualized care.^27,32,33 Moreover, most HCPs claimed to have incorporated the VALORA checklist to their routine practice, and even among those who did not incorporate it, increased awareness of clinical risk factors was indicated, reflecting the importance of its educational impact.

Several risk factors were already widely assessed prior to training, showing a ceiling effect. Nevertheless, there were notable improvements for those factors with lower baseline implementation rates, although these improvements were not statistically significant, likely reflecting insufficient statistical power given the sample size. The increase in family history of thrombosis assessment was particularly noteworthy, as it was the only item that showed a statistically significant increase post training. This result supports the idea that structured checklists can reduce practice variability with more thorough evaluation of complex and hereditary risk factors, thereby decreasing preventable adverse events. In the case of family history of thrombosis, it is well described that hereditary thrombophilic defects require careful counseling ³⁴ and that family history should be considered,^2,35,36 however, our results suggest that although some HCPs were routinely considering it, a quarter of them were only taking it into consideration for less than half of the users before training on the VALORA checklist.

On the other hand, some items had numerical increases that could be considered clinically significant even if the increase was not statistically significant, including diabetes, cholelithiasis, and other liver diseases. Diabetes assessment showed high baseline median values, and training primarily reduced variability by decreasing the proportion of HCPs reporting lower implementation rates, whereas both cholelithiasis and other liver disease assessments showed increases in median values after training. These items had particularly low baseline implementation rates, suggesting substantial room for improvement through structured guidance.

Overall satisfaction with the VALORA checklist was high. However, the complete absence of any dissatisfied respondents and the uniformly positive ratings may reflect social desirability bias. Participants’ awareness of the study’s focus on implementation and the investigators’ involvement in training may have influenced responses toward more favorable ratings than might be observed in routine, nonobserved settings. Without comparison with satisfaction levels associated with other decision-support tools, the absolute magnitude of satisfaction cannot be benchmarked. We observed a preference for an interactive digital format, which aligns with contemporary trends in clinical decision support by enhancing accessibility and workflow integration. Participants also expressed enthusiasm toward the implementation of automated risk assessment and contraceptive recommendations, highlighting the VALORA checklist potential to further standardize and individualize contraceptive counseling. ³⁷ Qualitative feedback also emphasized its perceived utility and simplicity, supporting future scalability in diverse real-world contexts.

Conclusions

The results of this pilot study support the utility of the VALORA checklist in improving the systematic, complete, and evidence-based assessment of clinical risk factors during OC counseling, according to self-reported HCP perceptions. These findings should be interpreted within the context of the study’s feasibility-level design, and confirmation in independent samples using more rigorous methodological approaches remains warranted. The VALORA checklist facilitates implementation of best-practice recommendations, addresses known gaps in routine practice, and demonstrates high acceptability among HCPs. Broader implementation across primary and speciality care settings, along with adaptation for integration into digital health technologies, represents a promising strategy to optimize safer and more equitable contraceptive care and to sustain improvements in routine clinical practice.

Authors’ Contributions

J.P.-C.: Conceptualization and methodology; J.P.-C. and M.A.O.: Supervision, validation, writing original draft, review, and editing.

Author Disclosure Statements

J.P.C. has received honoraria for consulting, participation in advisory boards or lecturing for Bayer Hispania, Theramex, Exeltis, and Organon outside the submitted work.

M.A.O. has received honoraria for consulting, participation in advisory boards or lecturing for Gedeon Richter, Theramex, Organon, Bayer Hispania and Bailleul outside the submitted work.

Funding Statement

This work was funded by Exeltis, Spain. Medical writing support provided by Evidenze Health España S.L.U. was funded by Exeltis, Spain. All authors received support from Exeltis, Spain for the submitted work.

Supplemental Material