Validation of the Thai version of the family reported outcome measure (FROM-16)© to assess the impact of disease on the partner or family members of patients with cancer

Health related quality of life (HRQOL) is of importance and considered an ultimate treatment goal for many conditions. HRQOL assessment has been widely used not only in research but also in clinical practice [1]. It is especially valuable in chronic diseases such as cancer, where patients may suffer for a long duration from the disease condition, complications or even the treatment process [1]. Although healthcare providers have turned their attention to patient’s HRQOL, the family’s HRQOL is usually overlooked. There is evidence that suggests a negative impact on family members in term of caregiving burden, finance, life style, or even the mental status [2, 3]. Study also shows that most family members needs are not met by healthcare services, resulting in distress and anxiety [4].

More importantly, a patient’s HRQOL may depend significantly on the HRQOL of the family members. The impact on quality of life for people who have family members suffering from cancer are expected to have circumstance that differ from the normal population [5, 6]. This is more profound in Eastern culture and Asian families who tend to be more holistic and interdependent, resulting in different cognitive and social orientation when compared with Western populations [7]. There is a lack of relevant instruments to apply in clinical settings [8] with only the recently reported Family Reported Outcome Measure (FROM-16), containing 16 items developed for family members of chronic disease patients in United Kingdom, being available. It has good psychometric properties and able to be used in routine practice taking only two minutes for questionnaire completion time [9]. The study aimed at translating and validating a Thai version of FROM-16 in Thai family members of cancer patients.

The findings show that the Thai version of FROM 16 is valid and reliable in Thai family members of cancer patients, with slightly different factor loading structure to the original version. Short time of administration was also observed with median time approximately 3 min (160 s).

FROM-16 is a questionnaire originated in English language. Validation tests reflect good psychometric properties in family member of chronic illness patient in the United Kingdom. The questionnaire is also highly applicable for routine use due to simplicity and short administration time. The affected area that is covered by FROM-16 was relevant to the most identified impact on Thai family members [8], but cross-cultural adaptation of questionnaire in population with different language may not feasible unless an appropriate translation process and psychometric properties tests were confirmed [21].

Neither floor nor ceiling effect was observed in either total or domain score analysis, with 15% being considered the maximum acceptable [22]. This indicates that the Thai FROM-16 is suitable for measuring the impact in this population. The mean and median scores were very similar to the original study [9], but tended to be lower in the cancer-related population. This finding may result from two reasons; the sampling method and cultural issues. The purposive sampling method by picking up the small group of most represented subjects, assessed by senior specialist in each specialty may result in higher scores when compare with a larger sample size. Second, the culture context in terms of caring for Thai family members, according to the finding in the interactive review data, considers taking care of a patient in the family as a gratitude, commitment, and responsibility [8], hence may result in lower response as an impact or burden. Furthermore, sex life is considered as a sensitive issue in Asian populations and may limit the response. No correlation was found with age and disease duration. This finding needs to be further confirmed in multivariate analysis before conclusions could be drawn.

The content validity was performed by a multidisciplinary expert panel, including physicians, pharmacists, and a nurse. Cognitive and debriefing results of the final version shows that Thai FROM-16 is easy to understand from both question and response options perspectives. During the pretest, there was no change for any items suggested by family members. The concurrent validity was confirmed by negative correlation between Thai FROM-16 and WHOQOL-BREF-THAI, indicating that higher impacts may contribute to lower HRQOL. Convergent and divergent validity, tested with hypothesis of negligible correlation for unrelated domains, also indicates a good result. On the other hand, this test score showed expected negative correlation with psychological domain in WHOQOL-BREF-THAI. Known group validity was confirmed based on literature findings of negative effect on certain groups of family members’ HRQOL. Female family member, having a higher burden as a caregiver, living with patient with advanced disease or limited physical ability of patients and those who have insufficient income were expected to be more affected [12]. These tests also reflected positive result for the hypothesis in terms of care and financial burden, with statistically significant higher Thai FROM-16 total scores. In contrast, there was no difference according to sex and severity of disease.

An interesting issue was found in factor analysis results. Three factors that exceeded the eigenvalue cutoff point were identified by PCF extraction and Cattells’ scree plot, which very similar to the original version, one eigenvalue was close to lower limit of 1 and may be consider to be removed. However, the oblimin rotation reveals different factor loading for both models, as seen in the structure matrix, where items 4 and 6 significantly loaded on two components with very close values. In order to clarify these issues, CFA was used to identify the best fit. All factor loading models including the original one were included for analysis. The 3-factor model revealed slightly better values for selected goodness of fit indices. This model consists of component one: item 1 and 3, component two: item 2, 4, 5, and 6, component three: items 7–16. The last component is similar to original version, while the emotional part was divided into 2 components. This finding may result from difference cultural aspects of Asian and Western populations. According to the cognitive interview in the pilot study, item 1: feeling worry and item 3: feeling sad were considered as self-emotion, and could keep it by themself, while item 2: feeling angry, item 4: feeling frustrated, item 5: difficult to find someone to talk to, and item 6: feeling difficulty of caring, were considered as the feeling that may affect the patient and/or other family members. This finding is consistent with the pattern of structural difference in cross-cultural adaptations in both generic and specific instrument in Asian countries [22, 23, 24].

A Cronbach’s alpha value of 0.86 reflects a good reliability of Thai FROM-16. The two domains also archived an acceptable value by Cronbach’s alpha of 0.73 and 0.82. Possibility of item drop out was demonstrated by alpha if item deleted analysis. None of removed items resulted in significant improvement of alpha values, indicating that all items contributed to the whole questionnaire and none should not be deleted.

This study had several limitations. All participants were recruited from a single center and most of the patients were receiving chemotherapy as the treatment. However, Srinagarind Hospital is the main tertiary referral center providing medical services across the northeast region of Thailand. Our sample was diagnosed with both oncologic and hematologic malignacy, and mostly diagnosed in advanced stages and currently receiving chemotherapy, hence these family members should be a good representative for the Thai population. Furthermore, chemotherapy is known as a treatment that contribute to the negative effects on HRQOL for both cancer patient and family members, [25] and will be a good reflection for negative impact in a cancer population.

This study shows good reliability and validity of the Thai version of FROM-16 with some differences in structural factor loadings. The questionnaire also requires short time for administration, so is suitable for routine clinical use. These findings generally support using of this questionnaire in Thai family members of cancer patients. The future challenge is to use this questionnaire in other modalities of treatment such as surgery, radiotherapy, and supportive care. Thai FROM-16 may provide potential benefits from use in other diseases, such chronic kidney disease, neurological and cardiac disease. Further study for validation in those population, and questionnaire responsiveness may be required.