Abstract
Background
Heart transplantation (HT) outcomes are greatly affected by psychological, social, behavioral, and self-care aspects. But still, there is no suitable instrument available for measuring readiness of HT among adult waiting-list patients, especially in the case of Iran.
Objective
To develop and validate the Heart Transplantation Readiness Scale for Adult Patients on the Waiting List (HTRW-A).
Methods
This exploratory sequential mixed-methods research consists of two phases at five cardiac centers in Tehran, Iran. In Phase 1 (qualitative), semi-structured interviews will be conducted with the participants including HT candidates, HT recipients, family members, nursing staff, medical doctors, transplant coordinators, and managers (estimated n=20-30). The qualitative data will be analyzed using the conventional content analysis method to find out the concept and dimensions of HT readiness. In Phase 2 (quantitative), the qualitative findings will be used to generate the items. Psychometric properties will be assessed based on numerous stated evaluations; these will include: face validity, content validity (CVR, CVI), construct validity (exploratory factor analysis), convergent validity (using SIPAT) and also Cronbach’s alpha to measure internal consistency, and ICC to evaluate test-retest reliability using data collected from approximately 250 to 300 patients who are placed on a waiting list for HT.
Expected Outcomes
The HTRW-A is intended to serve as a valid, reliable, and culturally sensitive method of obtaining the multidimensionality of one’s readiness for HT. By identifying areas where a patient may be lacking in their preparedness for the transplant process, healthcare providers can better offer specific interventions prior to a transplant.
Keywords
Background
Heart failure (HF), a comprehensive clinical syndrome, depicts a loss of cardiac performance, making it impossible for the heart to support its pumping functions to ensure the entire body receives its needed metabolism (Bozkurt et al., 2021). HF in its various forms can occur in people with congenital or altered heart anomalies. It has been associated with different clinical signs and symptoms, such as shortness of breath, weakness, peripheral edema, pulmonary rales, and elevated jugular venous pressure (Okwose et al., 2024; Schwinger, 2021).
An epidemiology study has suggested that, despite existing improvements in the management of cardiovascular diseases, HF has been viewed as a world epidemic (Becher et al., 2022). The American Heart Association (AHA) projects that by 2030, HF will impact eight million adults aged 18 and older, reflecting an increase from 2.4 percent in 2012 to 3 percent in 2030 (Virani et al., 2020). A recent study conducted globally estimates that the number of people living with HF exceeds 64 million, and the prevalence is still on the upward trend caused mainly by the ageing society and higher survival rates after acute cardiovascular incidents (Savarese et al., 2022). Moreover, the prevalence of HF is notably higher in Iran in comparison to other countries in Asia. A research study has uncovered a 32 percent association with death due to this serious illness indicating the critical need for effective treatment including transplantation (Chrysakis et al., 2024; Sarrafzadegan & Mohammmadifard, 2019).
For patients with end-stage HF that is not responding to medical treatment, heart transplantation (HT) is the only treatment option (Demiralp et al., 2024). The waiting period for HT is a very stressful experience for both patients and their families. It involves making decisions by a team of specialists, applying the best possible medical management continuously, and a large amount of psychological pressure (Kainuma et al., 2021). In most cases, patients may spend months or even years awaiting a transplant, due to the limited availability of donor organs. In some cases, even after such a long wait, when a donor organ is found, and after considering all factors, the transplant may not go forward as planned because of factors such as the poor health of the donor organ at the time of harvest (McMahon et al., 2021). Many obstacles to HT exist, including economic considerations, limited source of donors, risk of infection, risk of rejection, and requirements for lifelong immunosuppression (Ahmadi et al., 2021; Alsaeed & Husain, 2024; Maltês et al., 2021; Nassetta et al., 2022).
Various allocation models guide HT distribution, including candidate risk scores, blood group compatibility, donor-recipient matching for age and weight, recipient acuity, and waiting time (Ganapathi et al., 2023; Jain et al., 2025). Clinicians endeavor to select optimal recipients for this scarce resource (Dew et al., 2018). However, analysis of current selection criteria reveals predominant focus on physiological parameters which, while essential, may not capture the full spectrum of factors influencing transplant success.
Emerging evidence supports the importance of comprehensive pre-transplant preparation. A qualitative research in the United States revealed that HT patients foreseen complications and the need for mental health care after surgery, while they were making a patients’ right to proper care through self-advocacy, psychological health, nutrition, exercise, positive attitude, and trust in caregivers of the waiting list treated ones (Mack, 2022). On the other hand, research carried out in Spain showed that a multimodal prehabilitation including exercise, nutritional optimization, and psychological support postoperatively by improving rates of complications, shortening mechanical ventilation duration, and reducing the length of intensive care and hospital stays (Castel et al., 2022). The results of a systematic review showed that exercise-based prehabilitation programs improve functional capacity and possibly improve the recovery of patients after cardiac surgery from transplant (Metin et al., 2018).
Review of Existing Instruments for Transplant Readiness Assessment
Several instruments have been developed to assess various aspects of transplant candidacy and readiness. A critical review of these tools reveals significant limitations for assessing comprehensive readiness specifically in heart transplantation candidates.
Stanford Integrated Psychosocial Assessment for Transplant (SIPAT)
The SIPAT was developed by Maldonado et al. (2012) as a clinician-administered tool for psychosocial evaluation of transplant candidates. The instrument is composed of 18 questions grouped into 4 areas: The patient’s readiness to manage their illness, their social support system, the psychological stability and psychopathology they exhibit, and their substance use or abuse history. A total of 0 to 135 points can be scored on this tool; thus, the higher the number, the greater the psychosocial risk. This tool has been shown to have an excellent inter-rater reliability (ICC=0.94) and predictive validity for post-transplant outcomes during the original validation study (Maldonado et al., 2012).
While the SIPAT provides some evidence to support the assessment of readiness for HT, there are numerous limitations. The first example is that this tool, while initially developed in populations with liver transplants, was later utilized for a variety of other types of solid organ transplantation; however, it fails to capture several unique challenges associated with HT including but not limited to; dependency on devices (LVADs, pacemakers, and ICDs), the management of arrhythmia, and the individualized progression of symptoms in patients with advance heart failure. Secondly, because this tool requires a healthcare professional to administer it and necessitates trained evaluators, it adds additional workload on to the team, which impedes its routine clinical use. Thirdly, most validation studies for SIPAT have been conducted primarily within English-speaking Western populations and thus, there is limited evidence regarding its cross-cultural validity. Finally, SIPAT primarily addresses a risk assessment related to psychosocial factors; therefore, the criteria used may not adequately address positive factors associated with readiness (i.e., ability to do self-care, preparation for anticipated behaviors, and proactive coping mechanisms).
Psychosocial Assessment of Candidates for Transplantation (PACT)
Olbrisch and colleagues originally designed the PACT in 1989. As a historical document, the PACT is one of the first tools available to screen potential transplant recipients for psychosocial issues. The PACT includes eight main domains: social support, psychological health, lifestyle, understanding of transplantation, and past/current adherence. The PACT provides ratings from 1 to 5 in each of these eight areas, which combine to make a single overall score to represent an individual’s psychosocial suitability to undergo transplantation(s) (Olbrisch et al., 1989).
Although the PACT has some historical importance as one of the earliest developed tools for assessing psychosocial aspects of transplantation, it has a number of major limitations. To begin with, the PACT was created over 30 years ago when the field of transplantation had very different patient populations and treatment protocols than present day practice. In addition, the PACT provides broad, generalized rating on each domain, making it difficult to determine specific areas needing targeted interventions. Similar to the SIPAT, the PACT is administered by clinicians who may rely on their own clinical judgement rather than patient self-report to assess psychosocial factors. Finally, there is limited psychometric evidence for the PACT; most studies to date evaluating the PACT have only reported inter-rater reliability and no evaluations of the PACT’s overall validity or reliability.
Transplant Evaluation Rating Scale (TERS)
Twillman and colleagues (1993) developed the TERS, which consists of 10 sections, each measuring a different domain relevant to the evaluation of a potential transplant candidate, including social support, psychiatric history, substance abuse history, compliance history, and health behaviors (Twillman et al., 1993). The TERS has several limitations: it is clinician-administered, it has been developed for use only in renal transplant populations (and therefore has no specific validation for HT candidates), the TERS relies on pathology and risk factors as indicators of readiness to transplant rather than positive readiness indicators, and it has limited cross-cultural validation.
Physiological Scoring Systems
There are many physiological scoring systems, including the Candidate Risk Score (Benjamin et al., 2018) and Heart Failure Survival Score (Aaronson et al., 1997) that help guide the allocation and predictions of mortality. However, while both of these physiological tools are helpful to clinicians in the medical decision-making process, both do have very clear limitations in their use for determining readiness. The first being that they are primarily focused on the biological aspects related to the patients, while they do not incorporate or address psychological, behavioral or socio-economic dimensions that can be factored into the assessment of a patient’s preparedness. As well, neither tool is able to identify the modifiable parts of the patient’s profile that are amendable to intervention and correction before transplantation.
Self-Management and Adherence Tools
Generic self-management tools, such as the Self-Care of Heart Failure Index (SCHFI), developed by Riegel et al. (2009) are designed to evaluate self-care behaviors for heart failure (Riegel et al., 2009). Medication adherence tools, such as the Morisky Medication Adherence Scale (MMAS-8), measure general medication-taking behaviour (Morisky et al., 2008). However, the limitations of these tools for evaluating an individual’s readiness for transplantation include a focus on current behavioral patterns as opposed to providing prospective, specific preparation for transplantation; furthermore, there are no questions regarding readiness for the use of immunosuppressant; or how to adjust to lifestyle changes and psychological adjustments associated with transplantation.
Critical Gap in the Literature
The review of existing instruments reveals several critical gaps. First, no existing instrument was designed specifically for heart transplant candidates, missing unique aspects of HT readiness. Second, all identified instruments were developed and validated in Western populations, with no evidence of validity in Middle Eastern or specifically Iranian cultural contexts where family dynamics, religious beliefs, and healthcare behaviors differ significantly (Alitabar, 2023; Khashaba et al., 2025; Majda et al., 2022). Third, most existing tools require trained clinician administration. Fourth, in addition to assessing psychosocial risk, virtually all existing instruments either only assess psychosocial risk or do not include assessment of the psychosocial risk as an area of assessment in their instruments as a primary area of focus. Fifth, there is currently no single instrument that fully covers the complexity of assessing readiness from a multidimensional perspective.
Culture influences how an individual approaches their health behaviors, what coping strategies they may use to manage stress and to what extent they involve their relatives in their health decisions; this may vary widely from culture to culture (Jayasinghe et al., 2025). In Iran, this is especially a problem since there is no public policy in place that establishes a systematic way to measure readiness for HT in patients awaiting transplantations.
Therefore, it is imperative that researchers design a stable and culturally relevant instrument to measure readiness for HT in a multidimensional context. This paper presents a protocol for a mixed methods project to develop the “Heart Transplantation Readiness Scale for Waiting List Adult Patients” (HTRW-A).
Objectives
Primary Objective
To develop and validate the Heart Transplantation Readiness Scale for Adult Patients on the Waiting List (HTRW-A).
Phase 1 Objectives (Qualitative Study)
• To explore the concept of readiness for heart transplantation from the perspectives of patients, families, and healthcare professionals • To identify the key dimensions and attributes of heart transplantation readiness • To develop a preliminary conceptual framework for heart transplantation readiness
Phase 2 Objectives (Instrument Development and Validation)
• To generate items for the HTRW-A based on qualitative findings • To evaluate the face and content validity of the HTRW-A • To examine the construct validity of the HTRW-A using exploratory factor analysis • To evaluate the convergent validity of the HTRW-A • To determine the reliability of the HTRW-A
Methods
Study Design
Overview of Study Phases, Procedures, and Expected Outcomes
Abbreviations: AVE, Average Variance Extracted; CR, Construct Reliability; CVR, Content Validity Ratio; CVI, Content Validity Index; HT, Heart Transplantation; ICC, Intraclass Correlation Coefficient; I-CVI, Item-level CVI; KMO, Kaiser-Meyer-Olkin; S-CVI/Ave, Scale-level CVI Average; SIPAT, Stanford Integrated Psychosocial Assessment for Transplantation.
Phase 1: Qualitative Study
Study Setting
The qualitative phase will be conducted at five major cardiac centers in Tehran, Iran: Masih Daneshvari Hospital, Shahid Modarres Hospital, Shariati Hospital, Imam Khomeini Hospital, and Shahid Rajaee Cardiovascular Medical and Research Institute. These centers represent the primary HT programs in Iran and collectively perform the majority of heart transplantations nationally. Additionally, organ donation coordination offices affiliated with the Ministry of Health and Medical Education will be included for recruitment of transplant coordinators and managers.
Participants and Sampling
Maximum variation purposive sampling will be employed to identify participants from the diversity of views and experiences available (Tajik et al., 2025). Using a maximum variation sample means that participants will be selected based not only on the richness of their knowledge about the study’s research questions but also on their ability to convey their experiences or opinions regarding the study’s research goals and on their willingness to take part in the study. Maximum variation sampling will ensure inclusion of participants varying in age, gender, disease duration, time on waiting list (for patients), and years of experience (for healthcare providers).
The participants will include: HT waiting-list patients (estimated n=6-10) who are adults aged 18 years or older, on active waiting list for at least 30 days, able to communicate in Persian, and without severe cognitive impairment; post-HT recipients (estimated n=4-6) who are adults aged 18 years or older, at least 3 months post-transplant, and able to reflect on pre-transplant experience; family caregivers (estimated n=4-6) who are primary caregivers of waiting-list patients or recipients and adults aged 18 years or older; nurses (estimated n=3-5) with at least 2 years of experience in HT or heart failure units; physicians (estimated n=2-4) who are cardiologists or cardiac surgeons with HT experience; transplant coordinators (estimated n=2-3) currently working in transplant coordination; and transplant managers (estimated n=1-2) with administrative experience in transplant programs. The total estimated sample is 22-36 participants.
Based on previous qualitative studies in transplantation, we anticipate conducting 20-30 interviews to achieve data saturation (Hennink et al., 2017). However, sampling will continue until no new code emerge, consistent with recommendations for qualitative research rigor (Hennink et al., 2017).
Data Collection
Data collection will be through semi-structured, in-depth interviews. A guide for the interview was developed from a review of the literature and discussion with the research team, and will be refined iteratively through emerging findings.
Interview Guide for Patients and Family Members
Opening Question
“Can you describe your experience since you learned that you/your family member needed a heart transplant?”
Main Questions
1. “What does ‘being ready for a heart transplant’ mean to you?” 2. “How do you prepare physically, emotionally, and mentally for the transplant?” 3. “What challenges have you faced during your waiting period?” 4. “How do you cope with the wait for a transplant?” 5. “What kind of support do you have from your family, friends, and/or health care providers?” 6. “What kind of information or skill do you need to be better prepared?” 7. “What concerns/fears do you have with regard to the transplant itself and post-transplant?” 8. “How has your daily life changed since being placed on the waiting list?” 9. “What role does your family play in your preparation for your transplant?” 10. “How do you manage your medications/follow your treatment plan?”
Interview Guide for Healthcare Professionals
Opening Question
“How have you experienced working with potential/definitive heart transplant patients?”
Main Questions
1. “What is it that allows you to tell if a patient is ready for a heart transplant?” 2. “In addition to medical qualifications, what other criteria do you use to determine if a patient’s transplant procedure will be successful?” 3. “What are the characteristics of people who have a successful outcome after a heart transplant compared to those who struggle?” 4. “What are some of the most common issues you see that are a barrier to patient readiness for a heart transplant?” 5. “How do you currently assess whether or not a patient is ready for a heart transplant?” 6. “What is the role of the patient’s family in their readiness for a heart transplant?” 7. “What psychological/emotional factors can adversely impact a patient’s readiness for a heart transplant?” 8. “How significant is medication compliance in determining whether a patient is ready for a heart transplant?” 9. “What improvements do you suggest in the preparation of patients before undergoing a heart transplant?” 10. “During this time of waiting to be called in for a heart transplant, what types of resources/support systems have been beneficial to patients while waiting for their transplant?”
Probing Prompts
• “Can you expand on that?” • “Can you share an example of that?” • “How did you feel about that?” • “What happened next?” • “Why do you think this factor is significant?”
Closing Question
“Is there anything else about transplant readiness that you think is important that we haven’t discussed?”
Interview Procedures
To establish a good relationship with study participants and secure their written consent before proceeding with the study’s interviewing process. This includes scheduling individual interviews, according to each participant’s choice, so that each interview is held in a private, sound-controlled environment. All interviews will be audio recorded if the participant agrees, with each session beginning with demographic information requested from the individual before starting the main interview questions. If necessary, the researcher will ask probing questions in order to clarify or obtain a better understanding of the responder’s opinion, reaction; participants will also be provided the option to have the interview continued at a future meeting if a participant is determined to be fatigued.
At the conclusion of an interview, a follow-up should take place so that the participant may add any further thoughts or suggestions about the topic of study or be available for future clarification on any related issues. All interviews will be transcribed verbatim within 48 hours from the date of the interview; therefore, original recordings are to be securely saved using a password-protected computer file. The transcriptions for preliminary analysis and coding will be available before conducting additional interviews, as transcribed versions of interviews will be reviewed by the researchers’ faculty supervisors and will improve all future interviews conducted in connection with the study.
Data Analysis
Data will be analyzed qualitatively through conventional content analysis as defined by Hsieh and Shannon (2005) (Hsieh & Shannon, 2005) with operationalization of the data according to a model developed by Graneheim and Lundman (2004) (Graneheim & Lundman, 2004).
Step 1 - Transcription and Immersion
A transcript will be created of each audio file containing an interview and this transcript will be checked against the original audio recording to guarantee accuracy. The research team will read through each transcript numerous times as part of the immersion process in order to obtain a holistic understanding of the participants’ experience.
Step 2 - Identifying Meaning Units
Transcript portions related to the research question are referred to as Meaning Units and will be identified and marked.
Step 3 – Condensing & Coding
After identifying Meaning Units, they will be condensed and assigned code labels that reflect their essential meaning. Initial coding for each meaning unit will be performed independently by two researchers (VZ and MK) and will be followed by discussion until discrepancies are resolved.
Step 4 - Categorization
Similarly coded meaning units will be grouped together based on the similarities among the group of codes and/or their inherent properties during constant comparisons made within and between transcripts during the categorization process.
Step 5 - Content Mapping
The categorized data will be systematically examined to explore patterns and relationships across transcripts. This step provides a structured overview of the observable content related to transplant readiness, highlighting how categories relate to each other, without inferring latent meanings or counting occurrences.
Step 6 - Member Checking and Peer Debriefing
The preliminary findings will be shared with a subset of participants to confirm that the findings were accurate. Throughout the analysis phase of the study, the research team will conduct regular peer debriefing sessions.
Data Management
The qualitative data will be stored and managed in MAXQDA software (version 2022, VERBI Software, Berlin, Germany). An audit trail documenting the analytical decisions will be maintained through the course of the study.
Trustworthiness
Trustworthiness Strategies for Qualitative Phase
Based on Lincoln and Guba (1988) framework for establishing rigor in qualitative research.
Phase 2: Instrument Development and Validation
Conceptual Framework and Item Generation
The conceptual model will be developed inductively from qualitative findings. Categories derived from content analysis will inform operational definitions for each dimension and guide item generation. For each dimension identified, theoretical and operational definitions will be established, and items will be generated with attention to clarity, unidimensionality, and cultural appropriateness (DeVellis & Thorpe, 2022). Initial item generation will aim for 3-5 items per dimension to allow for item reduction during validation while maintaining adequate domain coverage. Items will be phrased as statements with response options on a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree), with negatively-worded items included to reduce response bias.
Sample Size Calculation
Exploratory Factor Analysis
In exploratory factor analysis, a minimum of 10 participants per item is generally recommended to obtain stable factor solutions (Costello & Osborne, 2005). Given that 25–30 items are expected to remain after content validity assessment, a sample of 250–300 participants will be recruited. Sampling adequacy will also be evaluated using the Kaiser–Meyer–Olkin (KMO) measure, with values of 0.70 or higher considered acceptable.
Convergent Validity
A subset of participants will be recruited to assess convergent validity with 100 individuals completing both the HTRW-A and SIPAT.
Test-Retest Reliability
In accordance with Kennedy et al.’s recommendations, this will involve 30 participants who will complete the HTRW-A (Test-Retest reliability), which will be retested after 2 weeks (Kennedy, 2022).
Attrition Consideration
Due to concerns over attrition, we expect to have around 15-20% dropouts (incomplete responses or dropouts), therefore, we expect the initial recruitment of 300-350 participants will cover for any potential attrition.
Participant Selection Criteria
Inclusion Criteria
• Adults aged 18 years or older • Registered on the active HT waiting list for at least 30 days • Able to read and understand Persian • Willing to provide informed consent • Cognitively able to complete self-report measures (assessed by transplant coordinator)
Exclusion Criteria
• Hospitalized in intensive care unit at time of assessment • Receiving mechanical circulatory support with altered consciousness • Documented severe cognitive impairment or psychiatric disorder affecting comprehension • Previously received heart transplantation
Validity Assessment
Face Validity
The qualitative assessment of face validity involving the review of each question by ten patients who satisfy eligibility criteria on the basis of difficulty, clarity and ambiguity is a way of determining face validity. Feedback from patients will be utilized to revise item wording, item structure, and item response options as it pertains to difficulties they encounter while answering the items.
Quantitative assessment of face validity will involve the participant rating the importance of each item on a five-level Likert-type scale (1 not important; 5 very important). The impact score for an item will be determined by multiplying the percentage of responses of four or five for the question with the average importance rating. Items which have impact scores of at least 1.5 will be retained; all other items will undergo further review for potential revision or deletion (Hajizadeh & Asghari, 2011).
Content Validity
Content validity will be assessed by an expert panel following guidelines by Polit and Beck (2006) (Polit & Beck, 2006).
Expert Panel Composition (n=10)
• 3 cardiologists/cardiac surgeons with HT experience • 2 transplant coordinators • 2 cardiovascular nurses with at least 5 years of experience • 2 nursing faculty members with expertise in instrument development • 1 psychologist with experience in transplant settings
Expert Inclusion Criteria
• Minimum 5 years of clinical or research experience in relevant field • Familiarity with psychometric principles (for methodologists) • Currently active in clinical practice or research
Procedure
Each expert will receive study objectives and conceptual framework, operational definitions of each dimension, complete item list organized by dimension, and rating forms for CVR and CVI assessment.
Qualitative Content Validity
Experts will evaluate items regarding grammar, appropriate wording, correct item placement, clarity, and simplicity. Modifications will be made based on consensus feedback.
Content Validity Ratio (CVR)
Each item will be rated as “Essential,” “Useful but not essential,” or “Not necessary.” CVR will be calculated using Lawshe’s formula (Lawshe, 1975). With 10 experts, items with CVR of 0.62 or greater will be retained (p<0.05).
Content Validity Index (CVI)
Each item will be rated for relevance on a 4-point scale: 1=Not Relevant, 2=Somewhat Relevant, 3=Relevant, 4=Highly Relevant. Item-level CVI (I-CVI) of 0.79 or greater indicates item retention; I-CVI between 0.70-0.78 requires revision; I-CVI below 0.70 indicates deletion (Lynn, 1986). Scale-level CVI (S-CVI/Ave) of 0.90 or greater indicates acceptable content validity (Polit et al., 2007).
Construct Validity
Construct validity will be examined using exploratory factor analysis (EFA) to identify the underlying dimensional structure of the HTRW-A (Watkins, 2018).
Preliminary Checks
• Missing data analysis: Items with greater than 10% missing values will be examined for patterns • Normality assessment: Skewness (acceptable range ±2) and kurtosis (acceptable range ±7) will be evaluated • Outlier detection: Multivariate outliers will be identified using Mahalanobis distance (p<0.001)
Factorability Assessment
• Kaiser-Meyer-Olkin (KMO) measure: 0.70 or greater required for adequate sampling • Bartlett’s test of sphericity: p<0.05 required • Anti-image correlation matrix: Diagonal values of 0.50 or greater required
Factor Extraction
Principal Axis Factoring (PAF) will be used as the extraction method.
Factor Retention Criteria
• Eigenvalue greater than 1.0 (Kaiser criterion) • Scree plot analysis (Cattell criterion) • Parallel analysis using Monte Carlo simulation (Horn’s method) • Theoretical interpretability • Minimum 3 items per factor
Factor Rotation
Oblique rotation (Promax with kappa=4) will be used, as dimensions of readiness are expected to be correlated. If factor correlations are weak (r<0.32), orthogonal rotation (Varimax) results will also be reported (Osborne, 2015).
Factor Interpretation
• Items with factor loadings of 0.40 or greater will be retained • Items with cross-loadings greater than 0.32 on multiple factors will be examined for conceptual fit and potentially deleted • Communalities below 0.30 will indicate potential item problems • Each factor will be named based on conceptual content of constituent items • Total variance explained will be reported (minimum 50% preferred)
Convergent Validity
Convergent validity will assess the degree to which the HTRW-A correlates with theoretically related measures (Abma et al., 2016). The Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) will be used as the reference instrument (Maldonado et al., 2012). We hypothesize moderate correlation (r=0.40-0.70) between HTRW-A and SIPAT total scores, as instruments measure related but distinct constructs. A subset of 100 participants will complete both instruments. Average Variance Extracted (AVE) of 0.50 or greater and Construct Reliability (CR) of 0.70 or greater will indicate adequate convergent validity (Fornell & Larcker, 1981).
Reliability Assessment
Internal Consistency
Cronbach’s alpha coefficient will be calculated for the total scale and each subscale identified through factor analysis. Alpha of 0.70 or greater is considered acceptable, 0.80-0.89 is good, and 0.90 or greater is excellent (Tavakol & Dennick, 2011). McDonald’s omega will also be calculated as a more robust reliability measure (Hayes & Coutts, 2020).
Test-Retest Reliability
Thirty patients will complete the HTRW-A at two time points, 14 days apart. This interval is sufficiently short to minimize true change in the construct while long enough to prevent recall effects (Streiner et al., 2024). Participants whose clinical status changes significantly between assessments will be excluded from test-retest analysis. Intraclass Correlation Coefficient (ICC) using a two-way mixed-effects model with absolute agreement will be calculated. ICC of 0.75 or greater is considered acceptable (Koo & Li, 2016). Standard Error of Measurement (SEM) and Minimal Detectable Change at 95% confidence (MDC95) will also be calculated.
Additional Assessments
Floor and Ceiling Effects
Total scores will be standardized to a 0-100 scale. Floor and ceiling effects below 15% are considered acceptable (Haqiqatkhah, 2025).
Feasibility
Average completion time (acceptable if 30 minutes or less) and missing data rate (acceptable if less than 5% per item) will be evaluated.
Scoring
Response options will use a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree). Negatively-worded items will be reverse-scored. Linear transformation to a 0-100 scale will be applied using the formula: Transformed Score = [(Actual raw score - Lowest possible raw score)/(Highest possible raw score - Lowest possible raw score)] × 100. This yields scores ranging from 0 (lowest readiness) to 100 (highest readiness).
Data Collection Procedure
Following ethics approval and institutional permissions, the researcher will visit study sites to recruit participants. After explanation of study objectives, voluntary nature of participation, and right to withdraw, eligible patients providing informed consent will complete demographic questionnaires and the HTRW-A. For participants unable to complete questionnaires independently, items will be read aloud by the researcher without interpretation.
Statistical Analysis
All quantitative analyses will be performed using SPSS software version 26 (IBM Corporation, Armonk, NY, USA). Descriptive statistics will summarize participant characteristics and item responses. Statistical significance will be set at p<0.05 for all analyses.
Summary of Psychometric Properties and Acceptance Criteria
Abbreviations: AVE, Average Variance Extracted; CR, Construct Reliability; CVR, Content Validity Ratio; I-CVI, Item-level Content Validity Index; ICC, Intraclass Correlation Coefficient; KMO, Kaiser-Meyer-Olkin; PAF, Principal Axis Factoring; S-CVI/Ave, Scale-level Content Validity Index Average; SIPAT, Stanford Integrated Psychosocial Assessment for Transplantation.
Study Timeline
Discussion
This protocol describes the development and validation of the Heart Transplantation Readiness Scale for Adult Patients on the Waiting List (HTRW-A), the first culturally-adapted, HT-specific instrument designed to assess multidimensional readiness among waiting-list patients.
Significance of the Study
This research addresses three significant deficiencies in current transplant research and practice through its research design. The three areas of investigation include:
Conceptual Gap
Patient readiness has been shown to have an impact on transplant success (Cupples et al., 2006), however, we do not define or operate within the construct of “readiness for heart transplantation”. As it stands, the definition of readiness is disjointed, since we are currently understanding the “readiness” construct within psychological, behavioral and social realms rather than as a comprehensive framework. By employing qualitative methods to explore stakeholder perspectives, this study will provide a grounded conceptual framework reflecting the multidimensional nature of readiness as experienced by patients and observed by clinicians.
Measurement Gap
Existing instruments assess isolated aspects of transplant candidacy. The SIPAT and PACT evaluate psychosocial factors but were not designed specifically for HT and lack validation in non-Western populations. Physiological scoring systems such as the CRS address only biological factors. No existing tool comprehensively captures the behavioral preparation, self-care capacity, medication adherence readiness, and psychological preparedness specific to HT candidates. The HTRW-A will integrate these dimensions into a unified assessment specifically designed for HT candidates.
Cultural Gap
Cultural distance exists in the difference in behaviors associated with approaches to the health care system, how families connect with one another, how faith/belief shapes one’s ability to cope, and how one approaches health care.), as well as in the cultural context in which they have developed (Vandecasteele et al., 2024). Thus, an evaluation tool that has been created for use within one specific culture may not produce the same results when evaluated using a different culture (Van de Vijver & Tanzer, 2004). The Iranian culture also has distinct characteristics of family involvement in the health care decision-making process, coping through religion and distinct communication between health care providers and patients. The creation of the HTRW-A in an Iranian health care context provides the opportunity for researchers to create a culturally appropriate and relevant assessment tool for the Iranian population and provides the framework for future adaptations of HTRW-A to be developed across cultures.
Comparison With Existing Instruments
There are many key distinctions between the HTRW-A and the existing instruments.
Stanford Integrated Psychosocial Assessment for Transplant (SIPAT)
The SIPAT is a clinician-administered tool developed to evaluate psychosocial candidacy for solid organ transplantation (Maldonado et al., 2012). While comprehensive in its psychosocial assessment, SIPAT has several limitations for HT-specific application. It was developed primarily for liver transplantation and later adapted for other organs. The HT-related WMS is only applicable to patients with heart transplants (HT) and those who have not undergone heart transplants (NHT). The HTRW-A will be a self-reported measure designed to capture the unique needs and preferences of HT candidates. It will allow patients to evaluate their own HT readiness and reduce the time required by clinicians for the assessment process. The HTRW-A is adapting to patients’ personal experiences before and during their HT journey. Thus, the HTRW-A has the potential for large-scale distribution.
Psychosocial Assessment of Candidates for Transplantation (PACT)
The PACT provides a general psychosocial evaluation framework for transplant candidates (Olbrisch et al., 1989). However, it lacks specificity for HT, does not address behavioral readiness or self-care capacity, and has limited validation across cultural contexts. The HTRW-A will address these limitations through its HT-specific focus and comprehensive dimensional coverage.
Candidate Risk Score (CRS) and Heart Failure Survival Score (HFSS)
These physiological scoring systems focus on mortality prediction (Aaronson et al., 1997; Benjamin et al., 2018). While valuable for allocation decisions, they do not assess modifiable readiness factors that could be targeted through pre-transplant interventions. The HTRW-A complements physiological assessments by evaluating preparedness factors amenable to intervention.
Comprehensive pre-transplant assessments should go beyond physiological measures as noted by both Dew et al. (2018) and other recent researchers. In their study, Dew et al. (2018), reaffirmed that psychosocial factors were significant predictors of post-transplant adherence and outcomes, thus, indicating the need for systematic assessment of patient readiness prior to transplant (Dew et al., 2018). The HTRW-A addresses this need by providing a standardized, patient-reported measure of multidimensional readiness.
Clinical Implications
The HTRW-A has potential clinical applications at multiple levels.
Individual Patient Care
Using the HTRW-A, nurse transplant coordinators and nurses will have the ability to analyze each patient’s readiness profile systematically to assist in recognizing specific limitations and create an individualized plan for preparing for transplant. For instance, a patient who had a low score for medication adherence readiness would likely benefit from receiving adherent counseling as well as learning how to organize their medication into dose boxes. A patient who scored low in the psychosocial category could be referred to receive support in the form of psychological counseling and/or develop skills to overcome any coping skill issues. Patients with inadequate social support might be connected to peer support groups and/or the Social Work department. The targeted approach allows for the appropriate use of preparation resources where they are needed most efficiently.
Transplant Program Quality Improvement
Aggregate HTRW-A data can identify common readiness gaps within transplant programs, informing development of targeted educational programs or support services. Programs might discover, for instance, that patients consistently score low on understanding of immunosuppression requirements, prompting development of enhanced education modules. This application aligns with quality improvement approaches in transplantation (Kobashigawa et al., 2014).
Resource Allocation Decisions
In settings with organ scarcity, the HTRW-A can complement physiological assessments to ensure that transplanted organs are allocated to patients who are best prepared to achieve optimal outcomes. This approach supports ethical allocation principles by addressing modifiable factors that influence transplant success. Importantly, the HTRW-A is intended to inform preparation interventions rather than serve as exclusion criteria, thereby ensuring equitable access while optimizing post-transplant outcomes.
Research Applications
The HTRW-A will enable researchers to evaluate prehabilitation interventions by measuring changes in readiness over time and examining relationships between baseline readiness and post-transplant outcomes. This facilitates rigorous evaluation of pre-transplant preparation programs.
Nursing Implications
This study has particular relevance for nursing practice. Nurses serve as primary coordinators of transplant patient care and are ideally positioned to assess and enhance patient readiness (Al-Beashi et al., 2024). Currently, readiness assessment often relies on informal clinical judgment rather than systematic evaluation. The HTRW-A will provide nurses with an evidence-based tool to: • Conduct standardized readiness assessments during waiting-list management visits • Document readiness status in patient records for team communication • Monitor changes in readiness over time to evaluate intervention effectiveness • Identify specific readiness deficits requiring targeted intervention • Communicate readiness concerns to the transplant team using objective measures • Plan and evaluate nursing interventions targeting readiness deficits • Facilitate patient education based on identified knowledge gaps • Support shared decision-making by helping patients understand their preparation needs
This validates the holistic nursing philosophy toward the provision of care to patients and supports the evidence-based practice of transplant nursing; the patient-reported instrument allows for patients to have increased involvement in their preparation for transplant, enabling them to be active participants in their own care consistent with patient-centered care principles (Tong et al., 2022; Q. Zhang et al., 2025; Y. m. Zhang et al., 2025).
Methodological Considerations
Several methodological decisions merit discussion.
Exploratory Sequential Design
The design selected—exploratory sequential mixed-methods—means that the content of the tools used in this study is based on the actual lived experiences of the stakeholders and not imposed by an outside framework; therefore, using this type of design provides maximized content validity and cultural relevance for instrument creation for domains with little prior exploration (Clark, 2019; Creswell & Creswell, 2023). The qualitative phase provides rich understanding of the readiness construct, while the quantitative phase establishes measurement properties necessary for clinical and research application.
Multiple Stakeholder Inclusion
By including multiple stakeholder groups that consist of patients at different stages (waiting-list and post-transplant), family caregivers, and numerous types of healthcare providers, there has been an effort to include as comprehensive a range of stakeholder perspectives as possible in order to fully cover the readiness construct; this triangulation of sources allows for the strengthening of content validity through representing the multidisciplinary nature of transplant care.
Exploratory Factor Analysis
The use of EFA rather than confirmatory factor analysis reflects the developmental nature of this instrument. EFA is appropriate when the dimensional structure of a construct is unknown, as is the case with HT readiness (Watkins, 2018). The factor structure identified will require confirmation in future studies using CFA with independent samples.
Strengths
This study has several methodological and practical strengths: 1. 2. 3. 4. 5. 6. 7.
Limitations
Several limitations should be acknowledged.
Single-Country Validation
The validation for this study will take place solely in Iran, restricting the translatability of the study’s findings for those living in different cultures. However, this focus helps provide culturally relevant information to the intended audience. Additionally, the methods described in this study may help others develop an instrument that incorporates the relevant features of the study’s population across cultures.
Absence of Confirmatory Factor Analysis
Confirmatory factor analysis (CFA) could not be employed in this study due to the logistical problems posed by the geographical distribution of heart transplant recipients throughout Iran and the relatively small number of heart transplants performed at each center. Therefore, the factor structure determined by exploratory factor analysis (EFA) must be confirmed by using larger independent samples in the future.
Cross-Sectional Psychometric Testing
The design due to its methodology does not permit assessment of predictive validity; therefore, for an assessment of whether the HTRW-A score will predict post-transplantation survival, rejection episodes, medication adherence, quality of life, and health care utilization, longitudinal data analyses are needed.
Self-Report Bias
The self-reported instrument will allow self-report bias of individuals responding to the HTRW-A. The potential for the responses to be affected by social desirability bias is particularly relevant for sensitive issues such as adherence behavior and substance use. Future research in this area may combine some objective measures or create external informant versions of the HTRW-A to confirm the acceptance of scores.
Exclusion of Severely Ill Patients
The exclusion of severely ill patients requiring intensive care unit hospitalization or the exclusion of those with severe cognitive impairment may decrease the use of this patient-reported instrument in the most at-risk population; however, the exclusions are necessary for the preservation of self-report accuracy.
Future Directions
Following initial validation, several directions for future research are recommended.
Predictive Validity
Research studies using a prospective cohort design can determine whether HTRW-A scores predict post-transplant outcomes such as survival, graft function, acute rejections episodes, medication adherence, quality of life, and utilization of healthcare services.
Cross-Cultural Adaptation
Using the methodology utilized in the present study, future studies should be conducted to adapt and subsequently validate the HTRW-A to appropriately represent other countries and cultures following guidelines established.
Clinical Cut-Off Scores
Future studies should provide clinically relevant cut-off scores to identify those who require additional intervention as opposed to those who are prepared to receive a transplant.
Intervention Development
Future studies should provide development of interventions that target specific deficiencies identified by the HTRW-A.
Brief Screening Version
A brief screening version of the HTRW-A should be developed for those working in busy clinical settings to quickly identify patients in need of an extensive assessment.
Electronic Administration
Development of the electronic version of the HTRW-A would promote routine assessment and longitudinal monitoring in the clinic setting.
Conclusion
This protocol describes a rigorous mixed-methods approach to developing and validating a comprehensive, culturally-adapted instrument for assessing heart transplantation readiness. The HTRW-A has potential to improve pre-transplant patient preparation, optimize resource allocation, and enhance transplant outcomes by providing healthcare teams—particularly nurses—with an evidence-based tool for systematic readiness assessment and intervention planning. The methodology described provides a template for instrument development in similar contexts where culturally-appropriate assessment tools are lacking.
Footnotes
Acknowledgments
This research project forms part of the doctoral dissertation of the first author (MK). The authors gratefully acknowledge the support of Shahid Beheshti University of Medical Sciences and the cooperation of participating healthcare centers.
ORCID iDs
Ethical Considerations
This study was approved by the Ethics Committee of Shahid Beheshti University of Medical Sciences (Approval Code: IR.SBMU.PHARMACY.REC.1403.273) and will be conducted in accordance with the Declaration of Helsinki.
Consent to Participate
Written informed consent will be obtained from all participants prior to data collection. Participants will receive comprehensive information regarding the study’s purpose, procedures, risks, and benefits. The voluntary nature of participation and the right to withdraw at any time without affecting medical care will be emphasized. Given the sensitive nature of exploring pre-transplant experiences, the following psychological safeguards will be explicitly included in the informed consent process: interviewers will receive training in trauma-informed interviewing techniques; the consent form will state that some questions may evoke emotional responses and that interviews will be paused or terminated if significant distress is observed; a clinical psychologist will be available for consultation and referral; and participants will receive contact information for psychological support services at participating centers. All data will be anonymized and stored securely with access restricted to the research team.
Author Contributions
Study conceptualization and design: MK, VZ, FM. Methodology development: MK, VZ, LV, HM, FB, FM. Data collection: MK. Data analysis and interpretation: MK, VZ, LV, HM, FB, FM, ZHA, BSK. Manuscript writing - original draft: MK. Manuscript writing - review and editing: All authors. Study supervision: VZ, FM. All authors have read and approved the final manuscript.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research received financial support from Shahid Beheshti University of Medical Sciences, Tehran, Iran. The funding body had no role in study design, data collection, analysis, interpretation, or manuscript preparation.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Data Availability Statement
Data sharing is not applicable to this protocol article. Data generated from the study will be available from the corresponding author upon reasonable request following study completion, subject to ethical approval and data protection requirements.