Patient-reported outcomes and experience measures in the Community Pharmacy setting: Theoretical and practical framework regarding the PROMs and PREMs

Abstract

Healthcare systems are evolving toward person-centered and value-driven models, in which the patient’s perspective plays a key role. Thus, patient-reported outcomes (PROs) and experience (PRE) are key elements for evaluating the impact of healthcare interventions from the patient’s own perspective. Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) are standardized and validated questionnaires designed to measure these variables, which could complement conventional clinical outcomes. This document describes the theoretical foundations of PROM and PREM and proposes a practical framework for their implementation in the field of community pharmacy. The manuscript addresses aspects related to their definition, psychometric properties (validity, reliability, sensitivity to change…), development process, and criteria for selecting the appropriate instrument. It also reviews some available instruments and their applications at the institutional, healthcare, and clinical levels. From a practical perspective, it outlines the key phases for their implementation in pharmaceutical practice (preliminary logistical preparation, initial consultation, and follow-up), highlighting the importance of therapeutic education, data collection infrastructure, and integration into clinical decision-making. The systematic measurement of PROs and PRE in community pharmacy can help improve the quality of care, promote patient engagement, optimize health outcomes, and reinforce the role of the pharmacist as a key healthcare professional in a value-based system.

INTRODUCTION

Healthcare systems are facing increasing healthcare expenditure due to therapeutic innovation, as well as the rising prevalence of chronic diseases associated with population ageing and increased life expectancy [1]. In this context, National Health System (NHS) must address the challenge of ensuring patient access to treatments and providing high-quality healthcare while safeguarding its own financial sustainability.

In addition, the different healthcare professions are promoting a shift towards a person-centered health care model in which patients are positioned as active participants in decisions affecting their health, and care is delivered in a respectful manner that responds to the preferences, needs, and values of the person living with the disease [2].

Within this context, value-based healthcare has emerged, taking into consideration the benefit that an intervention provides to patients [3]. This approach seeks to expand evidence-based medicine, which focuses on selecting appropriate therapies according to high-quality scientific evidence regarding their efficacy and/or effectiveness [4].

Health outcomes research, in turn, provides a methodological framework for generating evidence on the value of healthcare interventions. This discipline evaluates the efficacy and/or effectiveness of healthcare interventions, focusing on measuring the impact of treatments on people’s health. An important concept in health outcomes research is “treatment benefit”, meaning that interventions produce a favorable effect on a meaningful aspect of how the patient feels or functions in daily life and/or on survival. By definition, a therapy must have an impact on an aspect that substantially affects how the person feels and must also influence their daily activities [5].

Clinical outcome assessments (COAs) can be used to measure this treatment benefit. These provide information on the effect of therapy on a health-related aspect of interest and may be reported by patients or by other individuals involved in their care [5].

In particular, patient-reported measures have attracted considerable interest in recent years because of their potential to support progress towards a new person-centered, value-based paradigm. Therefore, the objectives of this study are: 1) to describe the theoretical foundations of these patient-reported measures, including their definition, types, examples of instruments, and related methodologies for their development and psychometric validation; 2) to propose a practical framework including possible actions to guide the use of these instruments in clinical practice; and 3) to present examples in which these measures may be applied in order to encourage their use in the community pharmacy setting.

METHODOLOGY

This narrative literature review was conducted through searches of PubMed and Google Scholar using the terms “Patient-Reported Outcome”, “Patient-Reported Outcomes Measure”, “Patient-Reported Experience”, “Patient-Reported Experience Measure”, and “Psychometry”. References considered relevant to and useful for addressing the objectives of the manuscript were selected.

The selected references were not limited to those identified through these searches. Grey literature was also consulted, including documents from scientific societies and healthcare institutions, conference publications, and other relevant sources; and the reference lists of previously published studies were reviewed. In addition, BiblioPRO and ePROVIDE, two databases of health-related questionnaires, were searched to identify examples of specific instruments.

Definition of patient-reported outcomes and experience measures

Patient-reported outcomes (PROs) are patients’ own perceptions of their symptoms, functional status and/or quality of life [6]. These PROs are measured using standardized and validated questionnaires completed by patients according to how they perceive their own functional status and/or well-being; these instruments are known as patient-reported outcome measures (PROMs) [6].

In the case of other measures, such as clinician-reported outcomes (ClinROs) or observer-reported outcomes (ObsROs), a healthcare professional or another informant (caregiver, family member, etc.) reports on the patient’s observed health status on their behalf [5]. Other measures of interest include performance outcomes (PerfOs), in which the patient’s ability to complete a test constitutes the outcome of interest [5]. However, the concept of PRO implies that no person other than the patient interprets the outcome [5].

Given the subjective nature of PROs, various symptoms and areas of functioning can be assessed via PROMs, including fatigue, insomnia, pain, loss of appetite, dyspnea, cognitive problems, anxiety or excessive worry, nausea, depression, sensory neuropathy, constipation and diarrhea [7]. Nevertheless, one area of particular interest is quality of life [8].

From a strictly economic perspective, quality of life may be understood as the set of material conditions and opportunities —including access to education— that depend on an individual’s financial circumstances [8]. However, in biomedical sciences, the term health-related quality of life (HRQoL) has been proposed as a multidimensional concept referring to the patient’s perception of the overall effect of disease and its impact on daily activities [9]. In the social sciences, subjective well-being (SWB) is used, based on people’s satisfaction with life (including health), expectations for the future, sense of fulfilment and other factors [8].

Patient-reported experience (PRE), in turn, reflects the patient’s perception of humanistic aspects related to the healthcare received [6,10]. Likewise, patient-reported experience measures (PREMs) are standardized and validated questionnaires used to measure humanistic aspects of healthcare, such as being treated with dignity or waiting times, among others [10]. The Institute for Patient Experience (IEXP, in SpanishInstituto para la Experiencia del Paciente) defines patient experience as the process that “…consists of listening to patients’ underlying needs and transforming the healthcare context together with them in order to achieve health and well-being outcomes that can be scientifically measured” [11], thus encompassing both PRE and PREM concepts.

Patient-reported incident measures (PRIMs) should also be highlighted. These are another type of tool designed to enable individuals to report aspects related to their safety [12]. Although their use is not currently widespread [12], their nature suggests that they could be of interest in community pharmacy practice.

In any case, the systematic integration of PROMs and PREMs into clinical practice has been associated with numerous benefits, including improved communication between healthcare professionals and patients, increased quantity and quality of information regarding disease symptoms and their impact on patients, optimization of disease management, greater patient satisfaction, improved quality of life and even improvements in conventional clinical outcomes [ 13].

Selection of the appropriate tool

In clinical practice, when using a sphygmomanometer, it is expected to measure blood pressure rather than cholesterol, expiratory volume or any other clinical variable; and its results should remain consistent across repeated measurements. In other words, the instrument is expected to be valid and reliable, respectively. PROMs and PREMs are likewise clinical tools that must demonstrate validity and reliability through psychometric studies [14,15]. In this regard, Table 1 presents the technical definitions of these psychometric properties related to PROMs and PREMs, together with indicative results that should be estimated for each of them, and which could therefore support their use in clinical practice [14, 15].

Table 1.

Psychometric properties of PROMs and PREMs.

Psychometric property		Description of the property [ 14 ]	Criterion for good measurement property (COSMIN) [ 15 ]
Validity	Content validity	The degree to which the questionnaire adequately measures the construct for which it was designed	Qualitative judgement of the adequacy of the questionnaire development process, its items, and the response format
	Structural validity	The degree to which questionnaire scores adequately reflect the dimensionality of the construct	CTT – EFA/PCA results: Factor loadings ≥0.30 for all items A maximum of 10% of items with loadings ≥0.30 on multiple factors Explained variance ≥50% and a structure consistent with the theoretical framework of the construct being measured; or scree plot results or Kaiser criterion (eigenvalues >1) consistent with the theoretical framework of the construct being measured CTT – CFA results: Adequate factor-solution fit indices: CFI, TLI, or comparable index >0.95; RMSEA <0.06; or SRMR <0.08 IRT/Rasch model: No violation of unidimensionality: CFI, TLI, or comparable index >0.95; RMSEA <0.06; or SRMR <0.08 No violation of local independence: residual correlations between items after controlling for the dominant factor <0.20; or Q3s <0.37 No violation of monotonicity: good visual fit of the plots; or item scalability >0.30 Good fit of the IRT model (χ² >0.01) or Rasch model (infit ≥0.5; outfit ≤1.5; standardized Z values between −2 and 2)
	Construct validity	The degree to which questionnaire scores are consistent with hypotheses based on the assumption that the instrument measures the intended construct	≥75% of predefined hypotheses confirmed (including criterion validity and known-groups validity)
		Criterion validity. The degree to which questionnaire scores adequately reflect the scores obtained with another instrument used as a “gold standard”	Correlation with the “gold standard” ≥0.70; or AUC ≥0.70
		Known-groups validity. The degree to which questionnaire scores discriminate between respondents belonging to predefined groups (e.g. disease severity, age, sex, etc.)	≥75% of predefined hypotheses confirmed (e.g. statistically significant differences in questionnaire scores between individuals with mild-to-moderate vs severe disease)
Reliability	Internal consistency	The degree of intercorrelation among theoretically related questionnaire items	At least low evidence of unidimensionality (for each dimension) Cronbach’s alpha ≥0.70
	Test–retest reliability	The degree to which questionnaire scores (or domain scores) remain stable across two administrations of the instrument to the same individual over a short period of time	ICC, weighted kappa, or Pearson/Spearman correlation ≥0.70
	Measurement error	Random and systematic error in questionnaire scores that is not attributable to changes in the construct being measured	SDC or LoA < MIC

PCA: Principal Component Analysis; CFA: Confirmatory Factor Analysis; EFA: Exploratory Factor Analysis; AUC: Area Under the Curve; ICC: Intraclass Correlation Coefficient; CFI: Comparative Fit Index; COSMIN: Consensus-based Standards for the selection of health Measurement Instruments; LoA: Limits of Agreement; MIC: Minimal Important Change; PREM: Patient-Reported Experience Measure; PROM: Patient-Reported Outcome Measure; RMSEA: Root Mean Square Error of Approximation; SDC: Smallest Detectable Change; SRMR: Standardized Root Mean Square Residual; CTT: Classical Test Theory; TLI: Tucker-Lewis Index; IRT: Item Response Theory.

Beyond validity and reliability, PROMs and PREMs must also be capable of detecting changes in disease status over time [14]. This property, known as responsiveness, demonstrates the usefulness of a questionnaire for monitoring a particular disease.

In addition, some PROMs are used as disease-screening tools [16] and must therefore demonstrate sensitivity and specificity [14], i.e. their ability to identify true positives and true negatives, respectively [ 17]. Receiver operating characteristic (ROC) curves represent the true-positive rate (sensitivity) against the false-positive rate (1–sensitivity) as the cut-off score indicating the presence of disease is varied. The ROC curve of a test that discriminates well between individuals with and without disease should approach the upper-left area of the graph(Figure 1A). Conversely, a test unable to discriminate between them will follow the 45° diagonal line of the graph (Figure 1B)[18].

Figure 1.

Example of the interpretation of a ROC curve. ROC: Receiver Operating Characteristic.

The discriminatory ability of the instrument can also be assessed using the area under the ROC curve (AUROC), with higher AUROC values approaching 1 indicating greater discriminatory ability [18].

In studies assessing diagnostic test accuracy, it may also be useful to estimate positive predictive value (PPV) and negative predictive value (NPV), which correspond to the proportion of individuals classified as positive and negative who truly have or do not have the disease, respectively [17].

Finally, the feasibility of the instrument for its intended use should be reviewed. This involves a comprehensive assessment of the clinical purpose for which the questionnaire was designed; whether the instrument is generic for any condition or specifically designed for a particular disease; its length (number of domains and items); scoring and interpretation rules; frequency and duration of administration; floor and ceiling effects (a high proportion of responses in the minimum and maximum categories); non-response rate; and other logistical aspects such as setting (healthcare facility or home) and mode of administration (paper-based, web-based digital format, mobile application, etc.) [19].

Questionnaire development and validation process

The development of a PROM or PREM involves more than simply grouping a series of questions together; psychometric studies are required to validate the questionnaire by demonstrating the measurement properties described above(Figure 2)[20].

Figure 2.

Development and validation process of a patient-reported outcome measure (PROM) or patient-reported experience measure (PREM)

PREM: Patient-Reported Experience Measure; PROM: Patient-Reported Outcome Measure

Likewise, a questionnaire previously developed and validated in another language and context should not simply be translated. In such cases, cross-cultural adaptation studies are required, involving translation of the questionnaire from the original language into the target language and back again, with the participation of several specialists in clinical translation [21]. In addition, some items that are not applicable to the new context in which the questionnaire will be used may need to be removed or clarified [22]. Finally, the version adapted to the new context must also demonstrate validity and reliability in the new population [21].

Practical aspects of prom and prem use

Available instruments

Numerous questionnaires are currently available to assess different constructs. In the case of quality of life, generic PROMs may be used to assess this construct regardless of the disease affecting the individual and may even be administered to healthy populations; alternatively, disease-specific PROMs include items reflecting the pathophysiology of particular diseases [19].

Among generic quality-of-life PROMs (Table 2)[23–32], although most are limited to providing a numerical value representing how patients perceive their quality of life, preference-based measures are particularly noteworthy. These PROMs assess quality of life and are additionally supported by studies designed to determine population preferences for the health states generated by the questionnaire. These studies make it possible to estimate a utility value ranging from 0 (death) to 1 (full health) [33], which can subsequently be multiplied by survival to estimate quality-adjusted life years (QALYs). Conceptually, therefore, 1 year of life in full health (utility = 1) is equivalent to 1 QALY, just as 2 years of life with quality of life reduced by half (utility = 0.5) are also equivalent to 1 QALY. Ultimately, the QALY is a health outcome unit that simultaneously combines improvements in survival and morbidity, potentially informing whether one treatment is efficient compared with another through the incremental cost–utility ratio (ICUR), which compares the costs and QALYs associated with two treatments [33]. Preference-based measures have therefore attracted particular interest in health economics [33 ].

Table 2.

Types and examples of generic PROMs for assessing quality of life in community pharmacy.

Construct	PROM	Description	Reliability of the original version:			Spanish version:
			Language (Country)	Internal consistency	ICC (test–retest)	Internal consistency	ICC (test–retest)
HRQoL	EQ-5D [ 23–24 ]	This is a population preference-based measure comprising one question for each of the five dimensions assessed: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Questions are answered by selecting a health state from either 3 (3-level EQ-5D) or 5 (5-level EQ-5D) possible options, ranging from “no problems” to “extreme problems”. It also includes a visual analogue scale (EQ-VAS), on which respondents indicate how they perceive their health status on the day of completion (0 = worse; 100 = best possible). Versions with a format adapted for use in pediatric populations are also available (EQ-5D-Y).	English (United Kingdom)	α = 0.74–0.95	–	α = 0.89–0.94	–
	SF-36 [ 25–27 ]	Includes 36 questions grouped into 8 dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Questions are answered using different types of Likert scales. Overall scores are calculated for the Physical Component Summary (PCS) and Mental Component Summary (MCS).	English (United States)	α = 0.74-0.95	–	α = 0.89-0.94	–
	SF-12 [ 25 , 27 ]	This is a shortened version of the SF-36 questionnaire comprising only 12 questions.	English (United States)	–	0.76–0.89	α = 0.78-0.85	–
	SF-6D [ 28 ]	This is a classification system derived from the SF-36 and SF-12 questionnaires. Studies have been conducted to assess population preferences for the health states defined by this classification, thereby allowing utility values to be estimated (preference-based measure).	–	–	–	–	–
SWB	QOLS [ 29–30 ]	A 16-item questionnaire grouped into 5 domains: physical and material well-being; relationships with other people and social, community and civic activities; personal development and fulfilment; recreation; and independence. Each question is answered using a Likert scale ranging from 0 (“completely dissatisfied”) to 7 (“completely satisfied”), giving a total score ranging from 16 to 112, with higher scores indicating better quality of life (SWB).	English (United States)	α = 0.82-0.92	0.78–0.84	α = 0.89	0.765
	WHOQOL-100 [ 31–32 ]	A 100-item questionnaire grouped into 6 domains: physical capacity; psychological health; level of independence; social relationships; environment; and spirituality, religion and personal beliefs. It also includes one question assessing overall quality of life and perceived general health. Completion is estimated to take approximately 30 minutes. Questions are answered using a Likert scale ranging from 1 (“not at all”) to 5 (“extremely”).	15 different settings (29 languages)	α = 0.71-0.86	0.68–0.90	α = 0.69-0.90	–
	WHOQOL-BREF [ 31–32 ]	Shortened version of the WHOQOL-100 questionnaire comprising only 26 items.	15 different settings (29 languages)	α = 0.66-0.84	–	α = 0.75-0.80	–

ICC: Intraclass Correlation Coefficient; PROM: Patient-Reported Outcome Measure; QOLS: Quality of Life Scale; SF-12: Short Form 12-item; SF-36: Short Form 36-item; SF-6D: Short Form 6 Dimensions; SWB: Subjective Well-Being; WHOQOL: World Health Organization Quality of Life; WHOQOL-BREF: World Health Organization Quality of Life (short version).

The previous sections described HRQoL and SWB as constructs related to quality of life, with SWB representing the broader concept. In health sciences, HRQoL is more commonly used because PROMs designed to measure it allow utilities to be estimated relatively easily [8]. This is not the case with SWB, whose greater conceptual complexity makes it more difficult to quantify population preferences. Consequently, estimating utilities using questionnaires that measure SWB is more complex —as these include questions beyond health, such as satisfaction with life goals, feelings of security, financial aspects, etc.— although this remains an active area of research, as demonstrated by the development of the EQ-HWB [34].

Regarding disease-specific quality of life PROMs, instruments have been developed for a wide range of conditions [35–52]. Table 3 presents several examples that may be of particular interest in community pharmacy practice because they concern highly prevalent chronic diseases [53] or conditions causing substantial disability [54]. In these cases, community pharmacy provides accessible and convenient healthcare for patients, which could translate into improved quality of life partly because of the closer follow-up enabled by easy access to a healthcare professional.

Among PROMs specifically developed to measure quality of life in a particular disease, the Kansas City Cardiomyopathy Questionnaire (KCCQ) is particularly noteworthy [55–58]. This questionnaire has undergone extensive development that not only demonstrates its validity and reliability but also allows clinical meaning to be assigned to the scores obtained [58 ].

Table 3.

Types and examples of disease-specific PROMs for assessing quality of life in community pharmacy.

Area	PROM	Ítems	Domains		Response scale	Reliability of the original version			Spanish version
			No	Names		Language (country)	Internal consistency	ICC (test–retest)	Internal consistency	ICC (test–retest)
Asthma	AQLQ [ 35–36 ]	20	4	Dyspnea / Mood / Social restriction / Concern	1 (“Not at all”) – 4 (“Very often”)	English (Australia)	α = 0.92–0.94	0.80	α = 0.78–0.84	–
Cancer (generic)	EORTC QLQ-C30 [ 37–38 ]	30	-	Common core structure for all tumor types (modules are added according to tumor type)	1 (“Not at all”) – 4 (“Very much”)	English	–	–	–	–
	EORTC QLU-C10D [ 39–41 ]	13	10	Physical functioning / Role functioning / Social functioning / Emotional functioning / Pain / Fatigue / Sleep / Appetite / Nausea / Bowel problems	1 (“No problems”) – 4 (“Severe problems”)	English	– A	– A	– A	– A
Cancer (specific)	EORTC QLQ-BR42 [ 42–44 ]	42	7	Body image / Arm symptoms / Breast symptoms / Systemic chemotherapy adverse effects / Endocrine symptoms / Hand–foot or neuropathy symptoms / Skeletal symptoms	1 (“Not at all”) – 4 (“Very much”)	English	–	–	α = 0.55–0.95	0.50–0.75
Heart disease	KCCQ [ 55–58 ]	23	6	Physical limitation / Symptom stability / Symptoms / Self-efficacy / Social limitation / Quality of life	Varies by item (from greater to lesser impairment)	English (United States)	α = 0.62–0.95	–	α = 0.46–0.93	0.45–0.91
Hypertension	MINICHAL [ 45–46 ]	16	2	Mental status / Somatic symptoms	0 (“Not at all”) – 3 (“Yes, a major challenge”)	Spanish (Spain)	–	–	α = 0.75–0.87	0.75–0.82
Diabetes	DQOL [ 47–49 ]	46	4	Satisfaction / Impact / Social–vocational concern / Diabetes-related concern	1 (“Very satisfied”) – 5 (“Not at all satisfied”)	English (United States)	α = 0.66–0.92	0.78–0.92	α = 0.68–0.84	0.52–0.81
Kidney disease	KDQOL [ 50 ]	36	8	Physical functioning / Role limitations due to physical problems / Bodily pain / General health / Mental health / Role limitations due to emotional problems / Social functioning / Vitality	Varies by item	English (United States)	α = 0.68–0.94	–	–	–
Skin disease	DLQI [ 51–52 ]	10	1	–	Varies by item (from greater to lesser impairment)	English (United Kingdom)	–	0.96–0.99	α = 0.83	0.88

AQLQ: Asthma Quality of Life Questionnaire; ICC: Intraclass Correlation Coefficient; DLQI: Dermatology Life Quality Index; DQOL: Diabetes Quality of Life; EORTC: European Organisation for Research and Treatment of Cancer; KCCQ: Kansas City Cardiomyopathy Questionnaire; KDQOL: Kidney Disease Quality of Life; MINICHAL: Mini-Questionnaire of Quality of Life in Arterial Hypertension; PROM: Patient-Reported Outcome Measure; QLQ-BR42: Quality of Life Questionnaire – Breast Cancer; QLU-C10D: Quality of Life Utility – Core 10 Dimensions; QLQ-C30: Quality of Life Questionnaire – Core Questionnaire.

^A Preference-based outcome measure (provides a utility value associated with the health state defined by the response levels selected for each item).

Thus, administration of the KCCQ makes it possible to classify cardiac disease according to the New York Health Assessment (NYHA), since 85% of patients with scores of 0–24 are in class III (marked limitation of physical activity) or IV (inability to perform physical activity without symptoms), whereas 80% of those with scores of 75–100 are in class I (no limitation of physical activity) or II (slight limitation of physical activity) [58]. KCCQ scores also provide prognostic information, as scores of 0–24 are associated with a threefold higher risk of hospitalization compared with scores of 75–100; individuals with scores of 25–49 have twice the risk of hospitalization; and scores of 50–74 are associated with a 1.5-fold higher risk [58]. These associations demonstrate the considerable potential of PROMs as tools in clinical practice.

However, quality of life is not the only aspect that may be relevant to monitor in community pharmacy (Table 4). Because pharmacies are healthcare establishments that people visit frequently and relatively regularly, PROMs designed to assess mental health may be key tools for screening and follow-up [59–64]. Community pharmacy also provides an opportunity to monitor pain using simple tools such as verbal rating scales (VRS), visual analogue scales (VAS), numerical rating scales (NRS) or facial expression scales (FES) [65], as well as more complex PROMs [66].

Table 4.

Types and examples of PROMs and PREMs for assessing other constructs in community pharmacy.

Construct	PROM	Items	Domains		Response scale	Reliability of the original version			Spanish version
			No	Names		Language (country)	Internal consistency	ICC (test–retest)	Internal consistency	ICC (test–retest)
Mental health	GHQ-12 [ 59–60 ]	12	3	Effective coping / Self-esteem / Stress	Variable scoring methods	English (United Kingdom)	–	–	α = 0.78	–
Anxiety	GAD-7 [ 61–62 ]	7	1	–	0 (“Not at all”) – 3 (“Nearly every day”)	English (United States)	–	–	–	–
Depression	PHQ-9 [ 63–64 ]	9 + 1	1	–	0 (“Not at all”) – 3 (“Nearly every day”)	English (United States)	–	–	–	–
Work activity	WPAI [ 73–74 ]	9	1	–	Varies by item	English (United States)	–	–	–	–
Social support	Duke-UNC FSSQ [ 70–72 ]	11	1	–	1 (“Much less than I would like”) – 5 (“As much as I would like”)	English (United States)	–	–	α = 0.90	0.92
Treatment satisfaction	SATMED-Q [ 67 ]	17	6	Treatment effectiveness / Convenience of use / Impact on daily activities / Medical care / Undesirable adverse effects / Overall satisfaction	Varies by item	Spanish (Spain)	–	–	α = 0.81–0.91	0.94
	TSQM-9 [ 68–69 ]	9	3	Effectiveness / Convenience / Overall satisfaction	Varies by item	French (France)	α = 0.84–0.93	0.74–0.78	–	–
Patient experience and person-centred care	IEXPAC [ 75 ]	11	3	Productive interactions / New relational model / Patient self-management	“Never” – “Always”	Spanish (Spain)	–	–	α = 0.73–0.77	–

ICC: Intraclass Correlation Coefficient; FSSQ: Functional Social Support Questionnaire; GAD-7: Generalized Anxiety Disorder 7-item scale; GHQ-12: General Health Questionnaire 12-item version; IEXPAC: Instrument for the Evaluation of the Experience of Chronic Patients; MMAS-8: Morisky Medication Adherence Scale 8-item version; PHQ-9: Patient Health Questionnaire 9-item version; PREM: Patient-Reported Experience Measure; PROM: Patient-Reported Outcome Measure; SATMED-Q: Satisfaction with Medication Questionnaire; TSQM-9: Treatment Satisfaction Questionnaire for Medication 9-item version; WPAI: Work Productivity and Activity Impairment; WHODAS: World Health Organization Disability Assessment Schedule.

Given the nature of the pharmacy profession, instruments designed to monitor treatment-related aspects, such as satisfaction with pharmacotherapy, may also be useful [[ 68]–[69]. However, the professional role of community pharmacists is not limited to pharmacotherapy; therefore, other tools designed to assess social support [70–72], work impact [73,74] or patient experience [75] may also have a place in pharmacy practice. Indeed, with regard to experience, a PREM has been developed in Australia to assess satisfaction with care received in community pharmacy [76]. Although it has not yet undergone cross-cultural adaptation for use in Spain [76], it represents a strategic direction for positioning community pharmacy as a key component in improving population health and patients’ experience of the healthcare system.

Access to PROMs and PREMs

Traditionally, access to questionnaires involved contacting their authors after manually searching the scientific literature. However, specific databases have now been developed that compile a wide range of these instruments, together with relevant information on each instrument (Table 5). Alternatively, some developers provide websites through which questionnaires may be requested.

Table 5.

Examples of websites providing access to PROMs and PREMs.

Website	URL	Content
BiblioPRO	https://www.bibliopro.org/	Wide range of questionnaires (developed and originally intended for use in Spain)
ePROVIDE	https://eprovide.mapi-trust.org/	Wide range of questionnaires (developed and originally intended for international use)
EuroQol Research Foundation	https://euroqol.org/	Instruments developed by the EuroQol Group (e.g. EQ-5D)
RAND Corporation	https://www.rand.org/health-care.html	Instruments developed by the RAND Corporation (e.g. Short Form, KDQOL)
EORTC	https://qol.eortc.org/#	Instruments developed by the EORTC (e.g. QLQ-C30)
IEMAC	https://www.iemac.es/iexpac/	Instruments developed by the IEMAC group (IEXPAC)

EORTC: European Organisation for Research and Treatment of Cancer; IEXPAC: Instrumento de Evaluación de la eXperiencia del PAciente Crónico; KDQOL: Kidney Disease Quality Of Life; PREM: Patient-Reported Experience Measure; PROM: Patient-Reported Outcome Measure; QLQ-C30: Quality of Life Questionnaire – Core Questionnaire.

In all cases, the intellectual property rights associated with questionnaires must be taken into consideration, and permission from the developers should be obtained before use.

Key elements for the effective implementation of PROMs and PREMs

Preparation for the first visit

The preparations that should be undertaken before the first visit, in sequence, include:

1. Assessing workload and verifying that appropriate follow-up can be ensured using the PROMs and/or PREMs intended for administration. If this is not possible, questionnaire use should be limited to those considered essential in order to ensure continuity of the care process incorporating PROMs and PREMs [77].

2. Ensuring that appropriate infrastructure is available to collect questionnaire responses and store them securely, either in paper or digital format [77].

3. Identifying individuals who may benefit from systematic monitoring of PROs and/or PREs and who will therefore be offered the intervention [77].

4. Identifying the individual’s needs in order to personalize the intervention. This should begin by gathering the available clinical and pharmacotherapeutic information and assessing psychosocial factors to identify potential barriers that could compromise the intervention [ 77, 78].

5. Selecting the PROMs and PREMs to be used according to the needs identified and obtaining any permissions required by the developers under the relevant conditions of use [77, 78]. To identify a personalised set of relevant instruments, referred to as a core outcome set (COS), scientific consensus among healthcare professionals [79] or other resources (COMET Handbook, COSMIN/COMET guidelines, COS-STAP, COS-STAD, COS-STAR, etc.) may be consulted [78]. Nevertheless, the COS used in community pharmacy would be expected to remain limited in order to optimize the intervention.

First visit

The objective of the first visit is to motivate the individual to engage with the proposed intervention [78]:

• Building trust: creating a welcoming and safe environment, demonstrating empathy and respect for the individual’s experiences.

• Exploring motivations and barriers: asking what might motivate or discourage the individual from following the proposed intervention, identifying barriers and proposing solutions.

• Positive reinforcement and empowerment: recognising and celebrating successes and promoting self-efficacy (the individual’s ability to manage their own health).

• Developing an action plan through shared decision-making: ensuring that it is realistic and specific, and agreeing on milestones and dates for reviewing progress.

Another fundamental component of any healthcare intervention is the provision of appropriate structured therapeutic education (Table 6) [80]. This may involve discussion with the individual or provision of printed or digital educational materials (video and audio). It would also be appropriate to support the individual during the first administration of the questionnaire in order to address any questions and to continue providing therapeutic education during follow-up [80].

Table 6.

Aspects to be included in structured therapeutic education regarding PROMs and PREMs.

Steps	Actions	Content
1	Introduction	What? What are PROs and PREs? What are PROMs and PREMs? What content is included in a PROM or PREM?
2	Purpose	Why? Why are we interested in the individual’s direct perspective on their health and/or experience? Why do we use PROMs and PREMs in routine clinical practice? Which patient-reported measures are of particular interest to us?
3	Completion method	How? How is a PROM or PREM administered and completed (digital platform or paper-based format, response scales, etc.)? How long do we expect it to take to complete the questionnaire? How often will we ask the individual to complete the PROMs and/or PREMs?
4	Presentation of results	What does it mean? How can the scores obtained be interpreted? What can change in responses over time help us understand?
5	Use	What actions will we take? How will we manage the PROs and/or PREs? What aspects can be addressed when the responses are reviewed jointly? How should the responses be discussed with healthcare professionals? In which cases should other healthcare professionals be consulted (primary care, emergency care, hospital care, etc.)?

Source: Authors’ own elaboration based on Groenewegen A, Biller OM, Greenhalgh J, Joseph A, Lindström Egholm C, et al. Patient education on PROM completion in clinical care settings: a scoping review. J Patient Rep Outcomes. 2026;10(1):37. PRE: Patient-Reported Experience; PREM: Patient-Reported Experience Measure; PRO: Patient-Reported Outcome; PROM: Patient-Reported Outcome Measure.

Finally, informed consent should preferably be obtained from the individual for the clinical use of their PROM and PREM responses and other personal data [78].

Follow-up visits

The first critical consideration during follow-up is how frequently the questionnaires should be administered. Although responses may be requested at shorter intervals at the beginning of follow-up or when a relevant therapeutic and/or clinical change occurs, administrations should be spaced as far apart as possible once the individual is clinically stable. Achieving a balance between obtaining sufficient information and avoiding questionnaire fatigue is essential for the success of the intervention [78].

Another key element in optimizing questionnaire administration is the use of information and communication technologies. These would allow individuals to complete questionnaires at home, enable responses to be reviewed before they attend the community pharmacy, and streamline review of the results. The consultation itself could be conducted remotely where necessary, feasible and convenient for the patient [78].

Finally, to promote adherence to completion of PROMs and/or PREMs, individuals should always receive clinical feedback on their responses, including positive reinforcement when the results are clinically favorable [78]. Otherwise, it would be advisable to have protocols for contacting other healthcare professionals involved in the patient’s care, so that relevant responses can be communicated where appropriate and with the individual’s prior agreement.

Applications of PROMs and PREMs

The increasing use of PROMs and PREMs is highlighting their various applications at the macro level (healthcare institutions), meso level (healthcare services) and micro level (healthcare professionals).

Applications for healthcare institutions

At the institutional level, the main application of these instruments, and particularly preference-based measures, is the estimation of utilities used in economic evaluations that inform decisions regarding the funding of new healthcare interventions [33]. PROs are frequently measured in clinical trials, partly to generate these utilities [33], but also as secondary efficacy outcomes associated with treatments [81, 82].

Beyond the generation of utilities, patient participation in institutional health technology assessment processes is becoming increasingly common [83 ]. Although there still appears to be room for improvement in Spain [83], the European framework for joint clinical assessment could encourage greater patient involvement in the non-clinical assessment of health technologies [84].

Funding decisions, even when made collaboratively with patients and based on economic evaluations, remain subject to the uncertainty inherent in clinical trials, whose external validity is limited by their controlled environment [85]. In real-world settings, where patients are more heterogeneous and treatment adherence is lower, treatment effectiveness may be compromised [85]. To address this uncertainty and “share” risk, agencies and pharmaceutical companies frequently enter into pay-for-performance agreements, under which the price of a medicine is linked to its outcomes in clinical practice [86]. Although efficacy outcomes —such as survival, disease progression and recurrence— have traditionally been used, newer agreements include adverse events such as fatigue or pain, as well as the ability to perform daily activities, all of which can only be assessed using PROMs [87].

Finally, these instruments can also provide information on population satisfaction with the NHS, thereby helping to guide improvements in healthcare delivery [88]. Indeed, quality of care is not only an ethical obligation towards the population; improving patient experience could also reduce costs associated with hospital admissions and ultimately contribute to the sustainability of the NHS [89].

Applications for healthcare facilities

At the level of hospital services and other healthcare facilities, PROMs and PREMs are increasingly being used as indicators of quality of care [90]. In this context, initiatives aimed at defining quality indicators, including PROM- and PREM-related aspects, have been developed for certification of inflammatory bowel disease [91], psoriasis [92] and dermato-oncology units [93]. These initiatives have demonstrated the feasibility of certifying the healthcare activity of specific hospital services, which could support the possibility of certifying community pharmacies that demonstrate a commitment to quality of care.

Applications for healthcare professionals

In routine clinical practice, PROMs and PREMs provide a key tool for involving patients in their own health, promoting awareness and self-care [94].

Although experience with PROMs and PREMs in community pharmacy remains limited, applications observed in other healthcare settings may be extrapolated, such as the Naveta initiative, which combines telepharmacy with systematic measurement of PROMs and PREMs in hospital pharmacy [95], or the initiatives being conducted by IEXP [96], among others.

Specific applications in community pharmacy

Beyond medicine-centered pharmaceutical activities —including the custody, storage and preservation of raw materials, medicinal products and medical devices— pharmaceutical care comprises a range of patient-centered activities: dispensing (and extemporaneous preparation), pharmaceutical consultation or minor ailment management (including therapeutic education and pharmacovigilance), and personalized medication review and follow-up [97].

Dispensing is the professional act whereby a medicine and/or medical device is supplied to the patient under optimal conditions, in accordance with current regulations, ensuring patient safety and preventing potential medication-related problems [97]. Although dispensing involves an interview with the individual before the medicine is supplied, the dispensing model in Spain makes it difficult to incorporate PROMs and PREMs. Nevertheless, individuals receiving a medication repackaging service using multi-compartment compliance aids or personalized dosage systems could benefit from the use of these instruments [ 98]. Likewise, the growing use of PRIMs could provide a powerful tool for the systematic detection and management of medication-related problems [12].

In pharmaceutical consultation or minor ailment management, understood as the service provided in response to a person attending the pharmacy seeking a solution to a health problem [97], PROMs could facilitate history-taking and identification of the most appropriate approach for each individual. However, this practice is likely to be feasible only when very short questionnaires or simple visual scales are administered. In other healthcare settings, pharmaceutical care includes the prescribing of certain medicines, which appears to be associated with a favorable patient experience and improved health outcomes, and where systematic use of PROMs could play a more important role in diagnosis and personalized treatment selection [99].

Medication review and follow-up probably represent the activity in which PROMs and PREMs could be most readily integrated, as this is a practice in which the pharmacist assumes responsibility for the patient’s medication-related needs, undertakes to detect, prevent and resolve medication-related problems, and aims to optimize health outcomes associated with treatment in order to improve the individual’s quality of life [97]. The definition of medication review and follow-up itself highlights the need to monitor health outcomes, particularly quality of life [97], and also raises the possibility of monitoring adherence or treatment satisfaction [100]. In this context, previous studies have shown that community pharmacy could improve treatment-related PROs in conditions such as pain or depression, with the potential to reduce their severity [101].

With regard to mental health, in addition to monitoring treatment [101], community pharmacy offers an opportunity to detect symptoms of depression [ 102], for which the use of PROMs is essential. Indeed, screening and referral of these individuals are associated with earlier diagnosis of the condition and have also been shown to be feasible in practice [102].

Other studies suggest that community pharmacy could also play a role in detecting opioid use disorder (OUD), alcohol use or other substance use disorders [102]. In Spain, opioid treatment for people with OUD is regulated by Royal Decree 75/1990, which decentralizes responsibility and allows the autonomous communities to organize dispensing [103]. Some regions have chosen to involve community pharmacies in the dispensing of substitution therapy, with the Methadone Dispensing Programme in Community Pharmacies (PDMOF, in SpanishPrograma de Dispensación de Metadona en Oficina de Farmacia) in Castilla-La Mancha representing one example of this approach [104]. Although community pharmacy already facilitates access to medication for people with OUD, the use of PROMs to monitor treatment could further optimize outcomes [105].

In any case, although the full potential of PROMs and PREMs will only become apparent as their use expands, the examples described show that there are already reasons to encourage their implementation in community pharmacy.

CONCLUSIONS

The systematic incorporation of patient-reported outcomes and experiences through PROMs and PREMs represents a strategic opportunity to transform community pharmacy practice towards a more person-centred and value-based model of care.

However, effective implementation requires appropriate selection of valid and reliable tools that ensure clinical usefulness, together with their integration into structured care processes. In this regard, community pharmacy provides an opportunity for their application, particularly in medication review and follow-up, where the proximity and accessibility of the pharmacist facilitate the integration of these clinical instruments.

Scientific evidence suggests that PROMs and PREMs can improve communication with patients, treatment adherence, satisfaction and, ultimately, health outcomes. Promoting their adoption in community pharmacy would therefore not only help optimize individualized pharmaceutical care but also position this healthcare setting as a key contributor to value generation within the healthcare system.