REVIEW ARTICLE Year : 2023  |  Volume : 50  |  Issue : 1  |  Page : 13-18

The cross-cultural adaptation process of a patient-reported outcome measure

Thangamani Ramalingam Alagappan
Faculty, Department of Physiotherapy, Sarvajanik College of Physiotherapy, Veer Narmad South Gujarat University, Surat, Gujarat, India

Date of Submission04-Oct-2021Date of Decision15-Nov-2021Date of Acceptance18-Jul-2022Date of Web Publication24-Mar-2023

Correspondence Address:
Thangamani Ramalingam Alagappan
Sarvajanik College of Physiotherapy, Veer Narmad South Gujarat University, Rampura, Chadda-Ole, Surat - 395 003, Gujarat
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/jss.jss_136_21

Patient-reported outcome measures (PROMs) are increasingly being used in the field of physiotherapy. In India, they are primarily used to determine clinical improvement in patients following intervention or for clinical audit purposes. However, clinical, academic, and research professionals' understanding of the construct, development, and psychometric validation of PROMs are uncertain, on the darker side, and unclear. As a result, this state could potentially lead to significant constraints in practice in terms of proper PROM selection, application, and administration. Furthermore, the lack of availability of PROMs in the patients' native language may necessitate a cross-cultural approach.

Keywords: Cross-cultural adaptation, patient-reported outcome measures, psychometric validation

How to cite this article:
Alagappan TR. The cross-cultural adaptation process of a patient-reported outcome measure. J Sci Soc 2023;50:13-8
  Patient-Reported Outcome Measures 

What are patient-reported outcome measures

According to the literature, patient-reported outcomes (PROs) are any feedback reports or statements about a patient's health condition. It may genuinely reflect the patient's experience with health care and be nonjudgmental of any health provider's response to the patient. The important five categories of PROs are health-related quality of life (QoL), functional status, symptoms and symptom burden, health behaviors, and the patient's health-care experience. Patient-reported outcome measures (PROMs) are measurement instruments that are commonly used to collect information on various aspects of a patient's health status, experience, and QoL. The development and use of questionnaires, interview schedules, and rating scales provide information from the patient's point of view as well as insight into how patients perceive the impact of treatments on their QoL. These instruments can be filled out by a patient (self-reported), a person about themselves (caregivers), or others on their behalf (parents on behalf of a child).[1]

Importance of patient-reported outcome measures in current practice

PROMs have the potential to improve the quality and outcomes of health-care services provided to patients. Certainly, they provide substantial evidence of health outcomes from the patient's perspective. They can be used to assess levels of health and need in populations and service users, and they can provide evidence of service outcomes for audit, quality assurance, and comparative performance evaluation over time. They may, however, improve the quality of interactions between health professionals and individual service users.[2]

Types or classification of patient-reported outcome measures

Seven major types of instruments are described, with examples. Each one has a different set of features and functions, as well as a different purpose. The classification should not be interpreted too strictly and is not mutually exclusive.[3]

Disease-specific patient-reported outcome measures

Patients' perceptions of a specific disease or health problem are measured by these instruments. There are now a variety of instruments available for common health issues, for example, the QoL questionnaire for asthma patients.

Population-specific patient-reported outcome measures

Individually-tailored instruments target specific demographics, such as children or the elderly, for example, CHIP-CE.

Dimension-specific patient-reported outcome measures

Health status can be assessed using instruments that focus on a specific dimension, such as physical function or symptom severity, or a global judgment of well-being, cognitive function, or role activities, for example, the Beck Depression Inventory.[3]

Generic patient-reported outcome measures

Generic instruments are intended to measure very broad aspects of health and thus have the potential to be useful for a wide range of patient groups and the general population, for example, SF-36.[4]

Individualized patient-reported outcome measures

Individualized instruments enable respondents to choose the content of their questionnaires. Generic instruments, in general, are designed to measure very broad aspects of health, making them potentially appropriate for a wide range of patient groups as well as the general population in general. As an example, consider the following: SF-36 items that are the most important areas of their lives that are affected by a disease or health problem and then rate how badly affected they are in each area and the rest of their lives, for example, Patient-Generated Index.[5]

Summary items patient-reported outcome measures

Responses to summary items are asked to summarize various aspects of their health status using a single item or a small number of items. Questions about long-term illness, for example, can be found in the UK General Household Survey.

Utility measures patient-reported outcome measures

Measures of utility take into account preferences or values attached to individual states of health and express them as a single index of health states. A cost-utility analysis can be performed using this type of instrument to determine the overall value of health states to society. As an example, EuroQol and EQ-5D mobility, self-care, main activity, pain/discomfort, and anxiety/depression make up the EuroQol EQ-5D's five components.

Patient-reported outcome measures can be used by WHOM?

It can be used by patients and clinicians to improve patient-provider communication and patient involvement in decision-making. This information will be used by the health system's decision-makers to inform health services program planning, policy development, and quality improvement efforts. Comparative and cost-effectiveness analyses, as well as other research questions, are conducted by researchers and policymakers.[6],[7]

How patient-reported outcome measures are used in general health-care practice?

PROMs are typically chosen based on a set of criteria, can be administered effectively in some ways, and can serve some purpose in general health-care practice. Fitzpatrick et al. should consider the following eight criteria when selecting PROMs for the use and application of instruments in clinical trials, economic evaluation, and routine patient care purposes. These include: Is the instrument content appropriate to questions addressed by the application? (Appropriateness) Is the instrument acceptable to patients? (Acceptability) Is it easy to administer and process? (Feasibility) How accurate and interpretable are the instrument's scores? (Precision and Interpretability) Are the results reproducible and internally consistent? (Reliability), and does it measure genuinely and capable of detecting changes over time? (Validity and Responsiveness).[3]

In general, PROMs can be utilized as a self-administered or interviewer-administered tool in clinical settings. The main factors to consider during an administration are cost-effectiveness, staff availability, and missing data issues, which may determine the route of administration such as telephone, E-mail, or postal.[8],[9] The majority of PROM instruments are intended for use in clinical trials and economic evaluations, but some have been proposed to assist health professionals in assessing and caring for individual patients. These instruments can provide a standardized, quantifiable measure of benefit against which to evaluate the outcomes of interventions. The increasing use of instruments for this application reflects the wide range of medical and surgical interventions aimed primarily at improving patients' well-being and QoL rather than extending life.[3],[10] Instrument data can assist clinicians in making decisions about various clinical inputs and tracking the outcomes of interventions provided by specific specialties. The patient-reported instruments are a valuable tool for clinicians in their patient care.[11] Self-administered questionnaires with adequate measurement properties allow patients to provide evidence of how they perceive their health in a timely manner, which can supplement existing clinical evidence. It has been proposed that patient-reported instruments be used to provide information on the health profile and health-care needs of the population.[12]

The addition of elements to PROMs such as a well-designed electronic system, including response automation, item selection tailoring, and reporting algorithms, may mark a watershed moment for PROMs in health-care practice.[13]

  Why Cross-Cultural Adaptation? 

PROMs – the nonavailability of instruments in non-English speaking countries is a real challenge that necessitates cross-cultural adaptation (CCA) and instrument translation from English to the target language. The CCA requires a translation process based on guidelines, as well as validation of psychometric properties in the target language.

Instead of developing a new questionnaire or tool, translating one allows for comparisons across populations, allowing researchers to examine functional status across a wide range of people and share information across cultural and linguistic barriers. It is now widely accepted that PROM tools intended for cross-cultural use must not only be well translated linguistically but also culturally adapted, to maintain the instrument's content validity. The primary goal of PROM CCA is to achieve equivalence between the original and adapted questionnaires using reliable and valid CCA methods. There are several methods for CCA of questionnaires. Most would achieve comparable results, according to experts alone, and choosing one is a matter of preference and logistics.

  Guidelines for Cross-Cultural Adaptation Process of Patient-Reported Outcome Measures 

The CCA of a PROM tool followed a combination of adaptation guidelines and psychometric evaluation. Despite the fact that more than 31 identified guidelines have been discovered, there appears to be no consensus on CCA methods. The use of committees, focus groups, and back translations was recommended and included in the majority of the guidelines. However, evidence for the best methods is generally lacking, although hints from works of the literature suggest that back translation may not be as necessary as previously perceived. More evidence is required to back up the recommendations. A questionnaire's adaptation and validation are two distinct processes that should be distinguished.[14],[15]

Beaton et al., 2000 guidelines for cross-cultural adaptation of a questionnaire

The guidelines described by Beaton et al. are based on a review of the medical, sociological, and psychological literature on CCA. This review resulted in the description of a thorough adaptation process aimed at achieving semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires. These guidelines serve as a framework for the translation and cultural adaptation (TCA) processes. Individual items, questionnaire instructions, and response options are all modified during the process. [Table 1] summarizes Beaton's methodology, which consists of Stages I–V. The final section (Stage VI) proposes an appraisal method in which an advisory committee or developers review the process and decide whether this is an acceptable translation. Although such a committee or the developers are unlikely to be involved in tracking translated versions of the instrument, this stage has been included in case a tracking system exists.[16]

The process of CCA attempts to achieve content equivalence between source and destination. The assumption that this method will ensure the conservation of psychometric qualities such as validity and reliability at the item and/or scale level is occasionally made. Following the completion of the translation, additional tests on the psychometric features of the adapted questionnaire should be performed. This will be briefly explored toward the end of the guidelines. The translation procedure described in this article is the first of three steps of the International Society for QOL Assessment project's three-step approach. The other two processes are to verify the scaling requirements (item performance and item weights) and to validate and create normative values for the new version. A brief listing of the stages involved in CCA is mentioned in [Table 1].

ISPOR task force for translation and cultural adaptation 2005

ISPOR established the QoL Special Interest Group— TCA group in 1999 to promote debate and the development of guidelines and standards for the TCA of PRO measures. Following the discovery of a general lack of consistency in current methods and published recommendations, the TCA group felt the need to build a holistic approach that synthesized the entire range of published methodologies. This approach led to the creation of TCA of PROs measures – Principles of good practice, as well as a report on current methodologies and an assessment of their strengths and limitations. Each method of TCA was thoroughly examined in terms of logic, components, major actors, and the potential benefits and hazards associated with each method and phase.[17]

  Validation of Psychometric Properties of a Patient-Reported Outcomes Measure After Cross-Cultural Adaptation 

The psychometric features and validation of a PROM provide evidence to health-care practitioners that the outcome measure operates as expected. It specifies the characteristics of an instrument or PROM, such as its reliability or appropriateness for use in a specific situation. Psychometric qualities are frequently calculated using statistical approaches and published in the literature as follows:

Statistical analyses

Demographic and clinical information of the study participants will be presented as counts, percentages, or means and standard deviations (SDs) appropriatelyRelative test–retest reliability will be determined by intraclass correlation coefficient (ICC [2, 1]). ICC values will be interpreted (1) as very high (ICC >0.90), high (ICC >0.75), moderate (ICC between 0.50 and 0.75), and low (ICC <0.50)[18]Absolute reliability will be determined by the standard error of measurement (SEM) using the formula SEM = SD, where SD is the average SD of the two-session scores (26, 27, 28). The minimal detectable change will be calculated using the formula 1.96x√2xSEM [19],[20]Systematic differences between the first and second session scores will be evaluated by paired Student's test[21]The limits of agreement between two sessions test–retest test scores will be evaluated by plotting the difference in scores during the two testing occasions against the baseline scores in the Bland–Altman graph. The limits of the agreement will be calculated by the 95% confidence interval within the difference score[22]Factor analysis, a principal component extraction with varimax rotation would load on one or more factors with an eigenvalue >1[23],[24]Construct convergent validity will be analyzed using the Pearson correlation coefficient (”r”) to determine the strength of the relationship between scores of associated measures. The strength of correlation will be interpreted as 0.00 to 0.19 – very weak, 0.20 to 0.39 – weak, 0.40 to 0.69 – moderate, 0.70 to 0.89 – strong correlations, and 0.90–1.00 – very strong correlation.[25]

Further, [Table 2] shows the overall statistical test requirements in the psychometric properties and validation of a cross-culturally adapted PROM.[26]

Table 2: Statistical tests requirement in psychometric validation of a cross-culturally adapted tool

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  Barriers to Cross-Cultural Adaptation of a Patient-Reported Outcomes Measure 

Epstein et al. discovered and proposed in a review of guidelines for CCA of questionnaires that the process of translating and adapting a questionnaire for a different cultural group represents a great challenge and requires enough time, skill, knowledge, and more experience in CCA methods. It necessitates an appropriate methodological strategy as well as quality translation for the application of the measurement tool. Especially, the criterion for analyzing the equivalence and techniques for evaluating the psychometric properties of collected data is essential. In general, the lack of evidence for CCA methods limits the possibilities of clear-cut recommendations. Even though the evidence for the best methods is lacking, the clues indicate that back translation may not be mandatory.[14] Furthermore, the linguistic difficulties (nonequivalent terms or idiomatic expressions) and attaining equivalence in CCA are difficult to complete. An important limitation for the researcher to handle is cultural equivalence, which determines to what extent an outcome measure is as suited for use in other cultures. According to Stevelink (2013), the method of cultural equivalency testing has been addressed insufficiently by researchers to yet. As a result, health-care practitioners should be aware that the use of PROMs necessitates the previous testing of cultural validity in the following context.[27]

  Conclusion 

PROMs are ideal for formulating treatment goals and assessing patient management progress. When applying PROMs, the lack of instruments in non-English speaking nations is a significant challenge. CCA requires a translation process based on criteria, as well as an assessment of psychometric features in the target language. The real challenges include cultural adaptation of the items rather than a word-for-word translation.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 

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  [Table 1], [Table 2]