A methodological review of the Short Form Health Survey 36 (SF-36) and its derivatives among breast cancer survivors

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1 DOI /s REVIEW A methodological review of the Short Form Health Survey 36 (SF-36) and its derivatives among breast cancer survivors Charlene Treanor Michael Donnelly Accepted: 11 August 2014 Ó Springer International Publishing Switzerland 2014 Abstract Purpose A systematic review of the validity, reliability and sensitivity of the Short Form (SF) health survey measures among breast cancer survivors. Methods We searched a number of databases for peerreviewed papers. The methodological quality of the papers was assessed using the COnsenus-based Standards for the selection of health Measurement INstruments (COSMIN). Results The review identified seven papers that assessed the psychometric properties of the SF-36 (n = 5), partial SF-36 (n = 1) and SF-12 (n = 1) among breast cancer survivors. Internal consistency scores for the SF measures ranged from acceptable to good across a range of language and ethnic sub-groups. The SF-36 demonstrated good convergent validity with respective subscales of the Functional Assessment of Cancer Treatment General scale and two lymphedema-specific measures. Divergent validity between the SF-36 and Lymph-ICF was modest. The SF-36 demonstrated good factor structure in the total breast cancer survivor study samples. However, the factor structure appeared to differ between specific language and ethnic sub-groups. The SF-36 discriminated between survivors who reported or did not report symptoms on the Breast Cancer Prevention Trial Symptom Checklist and SF-36 physical sub-scales, but not mental sub-scales, discriminated between survivors with C. Treanor (&) M. Donnelly UKCRC Centre of Excellence for Public Health, Queen s University Belfast, Belfast, Northern Ireland c.treanor@qub.ac.uk C. Treanor M. Donnelly Cancer Epidemiology and Health Services Research Group, Centre for Public Health, Queen s University Belfast, Institute of Clinical Sciences-B Building, Royal Victoria Hospital Site, Grosvenor Road, Belfast BT12 6BJ, Northern Ireland or without lymphedema. Methodological quality scores varied between and within papers. Conclusion Short Form measures appear to provide a reliable and valid indication of general health status among breast cancer survivors though the limited data suggests that particular caution is required when interpreting scores provided by non-english language groups. Further research is required to test the sensitivity or responsiveness of the measure. Keywords Breast cancer Quality of life Systematic review Psychometric properties Short Form health survey SF-36 Introduction Breast cancer is one of the most commonly occurring and most widely studied cancers in developing countries worldwide with 5-year relative survival rates which exceed 80 % [1]. Breast cancer survivors may experience adverse or late effects following treatment [2], and it is important to understand the impact of these effects on the health and well-being of cancer survivors [3, 4]. Increasingly, health care programmes are shifting focus from traditional clinical outcomes to patient-reported outcomes such as quality of life and health status (e.g. UK National Cancer Survivorship Initiative, 2010), particularly with respect to the new chronic condition-like model of cancer and the recognised importance of capturing the patient perspective in order to aid patient-centred practice, health care policy and the configuration of cancer services [5]. The Short Form (SF) health survey measure is a widely used, generic, self-report measure of health status. We conducted a systematic review of studies which assessed the validity, reliability and sensitivity of the SF-36 and

2 briefer versions (SF-12 and SF-8) among breast cancer survivors. The methodological quality of the papers was assessed using the COnsenus-based Standards for the selection of health Measurement INstruments (COSMIN) and related checklist [5]. Methods Review method PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO and the Social Sciences Citation Index were searched using terms which link breast cancer survivor, psychometric properties and SF measures. The search terms for measurement properties were based on a sensitive search filter developed by the COSMIN initiative which is appropriate for identifying papers which focus on the psychometric properties of a specific patient-reported outcome measure (see Fig. 1). Titles identified from the electronic search were exported to Refworks, and duplicates were removed. The eligibility of a paper was assessed independently by two reviewers, firstly according to its title followed by its abstract and the full paper. The bibliographies of included papers were searched for further eligible papers. Data Fig. 1 Complete search strategy (breast) AND (cancer OR neoplasm) AND (survivor* OR patient*) AND (medical outcomes study SF-36 OR medical outcomes study SF36 OR medical outcomes study SF 36 OR medical outcomes study short form-36 OR medical outcomes study short form 36 OR SF-36 OR SF36 OR SF 36 OR short form-36 OR short form 36 OR MOS SF-36 OR MOS SF36 OR MOS SF 36 OR MOS short form-36 OR MOS short form 36) OR (medical outcomes study SF-12 OR medical outcomes study SF12 OR medical outcomes study SF 12 OR medical outcomes study short form-12 OR medical outcomes study short form 12 OR SF-12 OR SF12 OR SF 12 OR short form-12 OR short form 12 OR MOS SF-12 OR MOS SF12 OR MOS SF 12 OR MOS short form-12 OR MOS short form 12) OR (medical outcomes study SF-8 OR medical outcomes study SF8 OR medical outcomes study SF 8 OR medical outcomes study short form-8 OR medical outcomes study short form 8 OR SF-8 OR SF8 OR SF 8 OR short form-8 OR short form 8 OR MOS SF-8 OR MOS SF8 OR MOS SF 8 OR MOS short form-8 OR MOS short form 8) AND (reproducib*[tw] OR methods [sh] OR valid*[tiab] OR reproducibility of results [MeSH] OR reliab*[tiab]) NOT (child* OR paed* OR ped*) AND (hospital OR inpatient) AND (pallia* OR end of life* OR terminal*)

3 extraction unto a standardised pro-forma was conducted independently. Inclusion/exclusion criteria Only papers that covered survivors of breast cancer were included. Survivors were defined as individuals who had completed treatment with curative intent (including surgery, radiotherapy and/or chemotherapy); survivors who were in receipt of adjuvant hormone therapy for prophylactic purposes were also included. Papers with survivors from sites other than breast cancer were included if a separate analysis was provided for breast cancer. Papers which assessed the psychometric properties of the SF-36, or its derivatives, the SF-12 and the SF-8 were included. Four papers met the above inclusion criteria. Three papers which utilised the SF measures to assess the psychometric properties of other measures e.g. Functional Assessment of Cancer Treatment-General scale (FACT-G) were also included. We focused on the taxonomy developed by the COSMIN initiative which covers three main domains and related measurement properties: reliability (internal consistency and measurement error); validity (content validity, construct validity, and criterion validity); and responsiveness. Peer-reviewed papers which assessed one or more of these measurement properties were included. Papers were excluded if they covered individuals in receipt of curative treatment (defined above) or palliative care; did not cover breast cancer survivors; did not assess the psychometric properties (defined above) of the SF-36 or its derivatives; and were not published in peer-review journals. Quality assessment The COSMIN checklist and scoring manual were used to appraise the methodological quality of studies. The checklist addresses the general requirements of psychometric studies, followed by separate sections on individual psychometric properties [6, 7]. In total, there are 114 checklist items. A four-point scoring system from excellent, good, fair to poor has been developed for each property [8]. Many checklist items require subjective judgements, and this aspect may account for low interrater reliability, thus the authors recommend independent quality assessors to decide a priori how items are to be interpreted [9]. Methodological quality was appraised independently by two reviewers with high agreement. It is not necessary to complete all items in the checklist, as each included study may address one or more psychometric properties. Results The search identified 270 papers after duplicates were removed see Fig. 2 for complete process of study selection. Tables 1 and 2 present the summary characteristics and findings of included papers. Five studies were conducted in the United States, and the remaining two studies were conducted in Dutchspeaking countries Belgium and The Netherlands, respectively. The SF-36 was the focus of all but one study which focussed on the SF-12. One study included four subscales only of the SF-36. The English language versions of the SF measures were used in three studies, other language versions include: Chinese (n = 2), Dutch (n = 2), Korean (n = 1) and Spanish (n = 1). Of the studies that primarily aimed to assess the psychometric properties of the SF measures, they focussed on internal consistency (n = 3), construct validity (n = 3), concurrent validity (n = 3) and discriminant validity (n = 1). The studies which provide psychometric information on the SF measures when used to assess other measures focussed on convergent and divergent validity (n = 1), discriminant validity (n = 1) and concurrent validity (n = 1). Due to the small number of papers identified, no exclusions were made based on methodological quality. Quality appraisal Methodological quality scores varied between and within papers. The quality assessment of internal consistency included scorings of excellent (n = 1), good (n = 1) and fair (n = 1). Methodological quality scores for construct validity (including discriminant validity which the COS- MIN initiative includes under construct validity) included good (n = 1) and poor (n = 3). The methodological quality of concurrent validity was assessed as fair in each study (n = 4). Within studies, methodological quality ranged from excellent to poor [10] and from good to fair [11, 12]. In general, the main reason for reduced methodological quality across and within studies was the use of less-than-optimal sample sizes, particularly for analyses by sub-group. Additionally, many of the studies did not clearly state a priori which hypotheses they were testing when assessing convergent and divergent validity, including the direction and size of association between convergent or divergent constructs. Internal consistency A range of ethnic and language groups were the focus of interest in the three US studies which assessed the internal consistency of the SF measures. The Chinese language SF- 12; Spanish, Korean Chinese and English language SF-36;

4 Fig. 2 Number of papers after implementation of search strategy and 4 subscales of the English language SF-36 were the measures of interest. A Cronbach s alpha co-efficient (a) score of greater than 0.7 indicates acceptable internal consistency. Two of the studies calculated internal consistency scores for the overall breast cancer sample as well as ethnic and language sub-groups. Internal consistency scores for the overall sample across the SF subscales were acceptable in both studies: from a = 0.76 to a = 0.91 [10] and a = 0.72 to a = 0.90 [12]. Only one study assessed the internal consistency scores for the SF-36 subscales among a European-American population; the scores were acceptable (range a = ) [10]. Two studies assessed the internal consistency of the SF- 36 among African-American breast cancer survivor populations. Similar internal consistency scores were reported in both studies, and with the exception of the social functioning subscale, these scores were in the acceptable to good range [10, 12]. For the purposes of comparison to the Ashing-Giwa et al. [10] study which utilised the full SF-36 to the Ashing-Giwa and Rosales [12] study which implemented only four SF-36 subscales, internal consistency scores for social functioning (a = 0.64; a = 0.68), physical role limitations (a = 0.86; a = 0.87), bodily pain (a = 0.86; a = 0.84) and general health (a = 0.79; a = 0.78) are highlighted, respectively. Two studies included Latina-American breast cancer survivors. One study administered the Spanish language SF-36 [10], whereas the other study administered the English language SF-36 (4 subscales) to two groups: survivors who were English language proficient (EP) and survivors who had limited English language proficiency (LEP) [12]. Nevertheless, internal consistency scores were all acceptable and generally similar across each sub-group between and within the two studies. For the purposes of comparison of the Ashing-Giwa et al. [10] study which utilised the full SF-36 to the Ashing-Giwa and Rosales (2013) study [12] which implemented only four SF-36 subscales, internal consistency scores for social functioning (a = 0.71; EP: a = 0.75; LEP: a = 0.73), physical role limitations (a = 0.94; EP: a = 0.87; LEP: a = 0.93), bodily pain (a = 0.84 EP: a = 0.89; LEP: a = 0.88) and general health (a = 0.84 EP: a = 0.74; LEP: a = 0.76) are highlighted, respectively [10, 12]. Among Chinese-American breast cancer survivors, internal consistency scores for the Chinese language SF-12 at both baseline and at one-year follow-up for the physical and mental component summary scores were acceptable (range a = and a = ) [13]. Internal consistency scores on the eight subscales of the SF-36 among Asian-American breast cancer survivors were also acceptable in an additional study (range a = ) [10]. Concurrent validity: convergent Two studies assessed the extent of convergence between subscales of the FACT-B and FACT-G measures and the

5 Table 1 Study characteristics of papers which focussed on the psychometric properties of the SF measures a Measure(s) of interest SF-36 Spanish-, Korean, Chinese and English language versions Functional Assessment of Cancer Therapy-Breast (FACT-B) SF-12 Chinese language version Functional Assessment of Cancer Therapy-General (FACT-G) SF-36 4 sub-scales only (general health; pain; role limitations due to physical health and social functioning) English language version Life Stress Scale MOS Social Support Survey Quality of medical care satisfaction (study specific) Spirituality (study specific) Body image (study specific) Sexual impact (study specific) Short Acculturation Scale for Hispanics Aim(s) To assess the construct validity of the QoL measures To assess the internal consistency of the measures by ethnic group To assess the concurrent validity of the FACT-B and the SF-36 Study design Cross-sectional telephone or postal survey To assess the internal consistency and construct validity of the SF-12 and the FACT-G among Chinese-American breast cancer survivors SF-36 English language version FACT-G Functional Living Index-Cancer (FLIC) Centre for Epidemiology Studies Depression (CES-D) To assess the reliability and validity of HRQoL b measures in minority ethnic populations (African-American; English language proficient (EP) Latina- American and limited English language proficient (LEP) Latina-American) To assess the concurrent validity of the FACT-G with the other outcome measures Longitudinal postal survey Cross-sectional survey (baseline) data obtained from an intervention study Population Criteria Criteria Criteria Criteria To assess whether the SF-36 and the FLIC can be used interchangeably to measure HRQoL among breast cancer survivors To assess whether similarly named sub-scales on the SF-36 and the FLIC measure similar dimensions of HRQoL To assess the extent to which the SF-36 and the FLIC are able to detect differences in HRQoL between breast cancer survivors with and without lymphedema Cross-sectional survey

6 Table 1 continued African-American, European- American, Asian-American and Latina-American breast cancer survivors between 1 and 5 years post-diagnosis (stages 0-III), aged 18 and over with no other cancer or major medical or psychiatric condition and identified from cancer registry and community groups Chinese-American Breast cancer survivors between 6 months and 3 years post-diagnosis (stages 0-III), aged over 18 years and identified from a cancer registry Breast cancer survivors (with no other cancer type) between 1 and 6 years post-diagnosis (stages 0-III), aged over 18 years, selfidentified as African- or Latina- American and identified from cancer registries, clinics and support groups Sample Sample Sample Sample n = 703 n = 74 completed survey at both time-points; age: mean = 54.6 years, SD = 9.1, range = years; age at diagnosis: mean = 52.7, SD = 8.7 years; time since diagnosis: mean = 2.4 year, SD = 2.0; 79 % diagnosed stage I-II African-American n = 135; age: mean = 56 years; age at diagnosis: mean = 52; time since diagnosis: mean = 3.6 years; 80 % diagnosed stages I-II 80 % more than high school education; 30 % low income less than $25,000 European-American n = 179; age: mean = 57 years; age at diagnosis: mean = 55; time since diagnosis: mean = 2.7 years; 74 % diagnosed stages I-II 78 % more than high school education; 40 % low income less than $25,000 Breast cancer survivors aged years, at least 3 months post-surgery recruited from outpatient lists n = 320 Lymphedema group n = 32; age: mean = 50.6 years, SD = 10.1; time since diagnosis: mean = 2.6 years, SD = 2.1 African-American n = 88; age: 70 % \ 65 years; 77 % diagnosed stage I-II; 82 % more than high school education; 31 % low income less than $25,000 EP Latina-American n = 95; 84 % \ 65 years; 79 % diagnosed stage I-II; 28 % more than high school education; 31 % low income less than $25,000 LEP Latina-American n = 137; 85 % \ 65 years; 78 % diagnosed stage I-II; 14 % more than high school education; 71 % low income less than $25,000 Non-lymphedema group n = 78; age: mean = 52.8 years, SD = 9.1; time since diagnosis: mean = 2.1 years, SD = 1.7

7 Table 1 continued 90 % more than high school education; 14 % low income less than $25,000 Latina-American n = 183; age: mean = 53 years; age at diagnosis: mean = 50; time since diagnosis: mean = 2.9 years; 75 % diagnosed stages I-II 47 % more than high school education; 50 % low income less than $25,000 Asian-American n = 206; age: mean = 54 years; age at diagnosis: mean = 51; time since diagnosis: mean = 2.9 years; 74 % diagnosed stages I-II 82 % more than high school education; 25 % low income less than $25,000 Psychometric properties assessed Internal consistency Internal consistency Internal consistency Convergent validity Construct validity Construct validity (exploratory factor analysis at baseline and Confirmatory factor analysis at 1-year followup) Construct validity (confirmatory factor analysis based on original factor structure) Discriminative validity Concurrent validity Concurrent validity Results Internal consistency Internal consistency Internal consistency Convergent validity Overall sample: physical functioning a = 0.91, physical role limitations a = 0.89, emotional role limitations a = 0.86, vitality = 0.85, mental health a = 0.84, social functioning a = 0.76, bodily pain a = 0.84, general health a = 0.80 Baseline: SF-12 physical component summary (PCS) score a = 0.82; SF-12 mental component summary score (MCS) a = 0.80 SF-36 social functioning, Total sample: a = 0.72; African- American sample: a = 0.68; LEP Latina-American sample: a = 0.73; EP Latina-American sample: a = 0.75 SF-36 PCS vs. SF-36 MCS: taub = 0.247

8 Table 1 continued African-American sample: physical functioning a = 0.93, physical role limitations a = 0.86, emotional role limitations a = 0.84, vitality = 0.87, mental health a = 0.82, social functioning a = 0.64, bodily pain a = 0.86, general health a = 0.79 European-American sample: physical functioning a = 0.88, physical role limitations a = 0.87, emotional role limitations a = 0.83, vitality = 0.90, mental health a = 0.86, social functioning a = 0.88, bodily pain a = 0.86, general health a = 0.76 Latina-American sample: physical functioning a = 0.93, physical role limitations a = 0.94, emotional role limitations a = 0.86, vitality = 0.86, mental health a = 0.84, social functioning a = 0.71, bodily pain a = 0.84, general health a = 0.80 Asian-American sample: physical functioning a = 0.89, physical role limitations a = 0.88, emotional role limitations a = 0.88, vitality = 0.79, mental health a = 0.83, social functioning a = 0.79, bodily pain a = 0.80, general health a = 0.84 One-year follow-up: SF-12 PCS a = 0.81; SF-12 MCS a = 0.79 SF-36 physical role limitations, Total sample: a = 0.90; African- American sample: a = 0.87; LEP Latina-American sample: a = 0.93; EP Latina-American sample: a = 0.87 Construct validity SF-36 pain, Total sample: a = 0.88; African-American sample: a = 0.84; LEP Latina- American sample: a = 0.88; EP Latina-American sample: a = 0.89 Baseline: two factors emerged Factor 1: All 6 MCS items loaded (not careful = 0.432, social time = 0.585, energy = 0.632, accomplished less emotional = 0.798, blue/ sad = 0.849, peaceful = 0.896), as well as 1 PCS item (general health = 0.426) SF-36 general health, Total sample: a = 0.77; African- American sample: a = 0.78; LEP Latina-American sample: a = 0.76; EP Latina-American sample: a = 0.74 SF-36 PCS vs. FLIC total score: tau-b = SF-36 MCS vs. FLIC total score: tau-b = SF-36 physical functioning vs. FLIC physical functioning: taub = Construct validity SF-36 mental health vs. FLIC mental health: tau-b = 0.586

9 Table 1 continued Construct validity c Factor 2: All 6 PCS items loaded (accomplished less physical = 0.444, general health = 0.476, pain interference = 0.589, limited in kind of work = 0.698, moderate activities = 0.742, climb several flights = 0.940) Only data from the SF-36 general health Perception items were presented in the paper Overall sample (n = 676): emotional role limitations, physical role limitations, pain and mental health loaded onto a single factor each; general health, physical functioning and vitality each had mostly good factor structure with a few inconsistencies; social functioning did not load onto any factors African-American (n = 131): general health, emotional role limitations and pain items had good factor structures; other items had loadings on multiple factors or no factors One-year follow-up: 58.1 % of common variance explained Factor 1: 5/6 PCS items (general health = 0.531, accomplished less physical = 0.728, pain interference = 0.735, moderate activities = 0.846, climb several flights of stairs = 0.977) but one (limited in kind of work) loaded and 3/6 MCS items (energy = 0.526, accomplished less emotional = and not careful) loaded = Factor 2: 1/6 PCS item loaded (limited in kind of work = 0.502), and 4/6 MCS items (social time = 0.733, not careful = peaceful = and blue/sad = 0.827) loaded Total sample: 4-factors explained 72 % of the variance and represented the factorial structure of the original SF-36 measure Factor 1: physical role limitations (all 4 items): range = ; social functioning (1 out of 2 items): 0.49 Factor 2: general health (4 out of 5 items): range = Factor 3: general health (2 out of 5 items): range = ; bodily pain (all 2 items): range = SF-36 social functioning vs. FLIC social functioning: taub = SF-36 general health vs. FLIC general health: tau-b = Discriminative validity SF-36 PCS (d = 1.20) but not MCS (d = 0.19) and each of the subscales (physical functioning: d = 1.11; physical role limitations: d = 1.02; emotional role limitations: d = 0.72; vitality: d = 0.74; social functioning: d = 0.60; bodily pain: d = 0.72 and general health: d = 0.69) with the exception of mental health (d = 0.35) had significant effect sizes

10 Table 1 continued European-American (n = 174): discrepancies with factor loading for physical functioning (items loaded onto two separate factors) and general health (3/5 items loaded onto one factor); other subscale items had consistent factor loadings Latina-American (n = 170): physical role limitations, emotional role limitations and mental health items had consistent factor loadings; other subscale items had less consistent factor loadings Asian-American (n = 201): consistent factor loadings for general health, emotional role limitations and pain; other subscale items loaded onto multiple or no factors Factor 4: general health (1 out of 5 items): 0.72; social functioning (all 2 items): range = African-American sample: 4-factors explained 73 % of the variance Factor 1: physical role limitations (all 4 items): range = ; social functioning (1 out of 2 items): 0.57 Concurrent validity e Factor 2: general health (3 out of 5 items): range = ; bodily pain (1 out of 2 items): 0.45 Sub-scales of the FACT-G were significantly correlated to respective sub-scales of the SF- 36 Factor 3: general health (1 out of 5 items): 0.74; bodily pain (all 2 items): range = and; social functioning (all 2 items): range =

11 Table 1 continued Total sample: SF-36 general health and FACT-G functional Well-being (q = 0.62); SF-36 physical functioning and FACT- G physical well-being (q = 0.60); SF-36 physical role limitations and FACT-G physical well-being (q = 0.61); SF-36 emotional role limitations and FACT-G functional well-being (q = 0.51); SF-36 vitality and FACT-G functional well-being (q = 0.64) and physical wellbeing (q = 0.64); SF-36 mental health and FACT-G emotional well-being (q = 0.65); SF-36 social functioning and FACT-G functional well-being (q = 0.62); SF-36 bodily pain and FACT-G physical well-being (q = 0.68) African-American: SF-36 general health and FACT-G functional Well-being (q = 0.60); SF-36 physical functioning and FACT- G physical well-being (q = 0.65); SF-36 physical role limitations and FACT-G physical Well-being (q = 0.62); SF-36 emotional role limitations and FACT-G functional well-being (q = 0.51) and FACT-G emotional Well-being (q = 0.51); SF-36 vitality and FACT-G functional well-being (q = 0.63); SF-36 mental health and FACT-G emotional wellbeing (q = 0.66); SF-36 social functioning and FACT-G functional well-being (q = 0.67); SF-36 bodily pain and FACT-G physical well-being (q = 0.70) Factor 4: general health (1 out of 5 items): 0.93 LEP Latina-American sample: 4-factors explained 75 % of the variance

12 Table 1 continued European-American: SF-36 general health and FACT-G functional Well-being (q = 0.59); SF-36 physical functioning and FACT-G physical well-being (q = 0.48); SF-36 physical role limitations and FACT-G physical well-being (q = 0.64); SF-36 emotional role limitations and FACT-G functional well-being (q = 0.61); SF-36 vitality and FACT-G functional well-being (q = 0.68); SF-36 mental health and FACT-G functional wellbeing (q = 0.75); SF-36 social functioning and FACT-G functional well-being (q = 0.65); SF-36 bodily pain and FACT-G physical well-being (q = 0.68) Latina-American: SF-36 general health and FACT-G functional Well-being (q = 0.60); SF-36 physical functioning and FACT- G physical well-being (q = 0.64); SF-36 physical role limitations and FACT-G physical Well-being (q = 0.61); SF-36 emotional role limitations and FACT-G physical well-being (q = 0.54); SF-36 vitality and FACT-G physical well-being (q = 0.66); SF-36 mental health and FACT-G emotional wellbeing (q = 0.64); SF-36 social functioning and FACT-G functional well-being (q = 0.61); SF-36 bodily pain and FACT-G physical well-being (q = 0.63). Factor 1: physical role limitations (all 4 items): range = ; bodily pain: (1 out of 2 items): range = 0.47; social functioning (1 out of 2 items): 0.42 Factor 2: general health (3 out of 5 items): range =

13 Table 1 continued Asian-American: SF-36 general health and FACT-G functional well-being (q = 0.66) and FACT-G physical Well-being (q = 0.66); SF-36 physical functioning and FACT-G functional well-being (q = 0.57); SF-36 physical role limitations and FACT-G functional Well-being (q = 0.53) and FACT-G physical Well-being (q = 0.53); SF-36 emotional role limitations and FACT-G functional wellbeing (q = 0.50); SF-36 vitality and FACT-G physical well-being (q = 0.72); SF-36 mental health and FACT-G emotional wellbeing (q = 0.62); SF-36 social functioning and FACT-G physical well-being (q = 0.56); SF-36 bodily pain and FACT-G physical well-being (q = 0.68) Factor 3: general health (3 out of 5 items): range = ; bodily pain (1 out of 2 items): 0.51 Factor 4: general health (1 out of 5 items): 0.74; bodily pain (all 2 items): range = ; social functioning (all 2 items): range = EP Latina-American sample: 4-factors explained 73 % of the variance Factor 1: physical role limitations (all 4 items): range = ; social functioning (1 out of 2 items): 0.52 Factor 2: general health (2 out of 5 items): range = Factor 3: general health (2 out of 5 items): range = ; bodily pain (all 2 items): range =

14 Table 1 continued Factor 4: general health (2 out of 5 items): range = ; social functioning (all 2 items): range = Concurrent validity d African-American: SF-36 general health vs. FACT-G physical well-being (q = 0.60); vs. FACT-G social/family wellbeing (q = 0.01 n.s.*); vs. FACT-G emotional well-being (q = 0.39); vs. FACT-G functional well-being (q = 0.43) SF-36 social functioning vs. FACT-G physical well-being (q = 0.69); vs. FACT-G social/ family well-being (q = 0.16 n.s.*); vs. FACT-G emotional well-being (q = 0.37); vs. FACT-G functional well-being (q = 0.59) SF-36 physical role limitations vs. FACT-G physical well-being (q = 0.56); vs. FACT-G social/ family well-being (q =-0.01 n.s.*); vs. FACT-G emotional well-being (q = 0.22); vs. FACT-G functional well-being (q = 0.51) SF-36 bodily pain vs. FACT-G physical well-being (q = 0.69); vs. FACT-G social/family wellbeing (q = 0.04 n.s.*); vs. FACT-G emotional well-being (q = 0.20 n.s.); vs. FACT-G functional well-being (q = 0.52)

15 Table 1 continued LEP Latina-American: SF-36 general health vs. FACT-G physical well-being (q = 0.54); vs. FACT-G social/family wellbeing (q = 0.42); vs. FACT-G emotional well-being (q = 0.44); vs. FACT-G functional well-being (q = 0.56) SF-36 social functioning vs. FACT-G physical well-being (q = 0.56); vs. FACT-G social/ family well-being (q = 0.40); vs. FACT-G emotional wellbeing (q = 0.43); vs. FACT-G functional well-being (q = 0.61) SF-36 physical role limitations vs. FACT-G physical well-being (q = 0.51); vs. FACT-G social/ family well-being (q =-0.17); vs. FACT-G emotional wellbeing (q = 0.25); vs. FACT-G functional well-being (q = 0.44) SF-36 bodily pain vs. FACT-G physical well-being (q = 0.62); vs. FACT-G social/family wellbeing (q = 0.21 n.s.*); vs. FACT-G emotional well-being (q = 0.27); vs. FACT-G functional well-being (q = 0.53) EP Latina-American: SF-36 general health vs. FACT-G physical well-being (q = 0.50); vs. FACT-G social/family wellbeing (q = 0.36); vs. FACT-G emotional well-being (q = 0.42); vs. FACT-G functional well-being (q = 0.53)

16 Table 1 continued SF-36 social functioning vs. FACT-G physical well-being (q = 0.49); vs. FACT-G social/ family well-being (q = 0.43); vs. FACT-G emotional wellbeing (q = 0.44); vs. FACT-G functional well-being (q = 0.62) SF-36 physical role limitations vs. FACT-G physical well-being (q = 0.50); vs. FACT-G social/ family well-being (q =-0.23); vs. FACT-G emotional wellbeing (q = 0.18 n.s.); vs. FACT- G functional well-being (q = 0.53) SF-36 bodily pain vs. FACT-G physical well-being (q = 0.71); vs. FACT-G social/family wellbeing (q = 0.22); vs. FACT-G emotional well-being (q = 0.25); vs. FACT-G functional well-being (q = 0.63) Authors conclusions Internal consistency Internal consistency Internal consistency Convergent validity The SF-36 was assessed as having moderate-to-strong reliability across the different ethnic groups The SF-12 has good internal consistency and the measure is reliable in a Chinese-American population The SF-36 had acceptable internal consistency across the three subgroups SF-36 PCS and MCS measure distinct domains of HRQoL Construct validity Construct validity Construct validity There is a modest degree of construct overlap between the SF-36 PCS and MCS and the FLIC total score Overall, the SF-36 presented good factor structure, with the exception of the social functioning scale The SF-12 at baseline had good factor structure which closely reflected the 2 constructs of the measure The SF-36 role limitations due to physical health subscale had good factor structure across each sub-group The physical, mental and social domains of HRQoL are similar in the two measures, but general health is not similar

17 Table 1 continued Factor structures by ethnic groups were less consistent The factor structure of the SF-12 at follow-up was less robust, and this may be due to a response shift in cancer survivor s interpretation of the items. The SF-36 general health, pain and social functioning sub-scales had inconsistent factor structures across the three sub-groups Concurrent validity The SF-36 is acceptable for use in breast cancer survivor populations from ethnic minority and low-literacy groups There was good concurrent validity demonstrated between the FACT-G and the SF-36 Concurrent validity Discriminative validity SF-36 is able to discriminate between breast cancer survivors with and without lymphedema in terms of physical HRQoL, but not mental HRQoL There was good concurrent validity demonstrated between the FACT-G and the SF-36 Quality Assessment Internal consistency Internal consistency Internal consistency Concurrent validity Excellent Fair Good Construct validity Construct validity Poor Poor Concurrent validity Construct validity Concurrent validity Fair Good Fair Fair b d Unless where necessary information regarding the SF measures only is reported HRQoL = health-related quality-of-life Participants with missing data were excluded from this analysis Although, the FACT-G was focus of the analysis, psychometric information on the SF-36 is also provided Only the highest, positive correlations are reported in the table a c e * n.s. = non-significant

18 SF-36 [10, 12]. The Ashing-Giwa et al. [10] study analysed convergent validity among the total sample and four ethnic and language sub-groups: African-American, European- American, Latina-American and Asian-American. The strength and direction of associations between respective SF and FACT-B subscales were similar across the total sample and ethnic and language sub-groups see Table 2. The Ashing-Giwa and Rosales [12] study analysed the concurrent validity between the FACT-G and four subscales of the SF-36 among three sub-groups: African- American; LEP and EP Latina-Americans. Except for a few discrepancies, the strength and direction of associations were similar between the FACT-G and SF-36 subscales among each of the sub-groups see Table 2. Of note, a strong association was found between the SF-36 social functioning and the FACT-G social/family wellbeing subscales among the African-American group compared to low-moderate correlations observed among the LEP and EP Latina-American groups. Two additional studies assessed the convergent validity of SF-36 subscales and respective lymphedema-specific measures among breast cancer survivors in Dutch-speaking countries. One of the studies stated five a priori hypotheses to assess convergent validity between the Lymph-ICF and the SF-36. Each of the hypotheses was supported and listed in Table 2 [14]. The second study demonstrated acceptable convergent validity with the ULL27 [15]. The highest, positive correlations were between the SF-36 psychological subscales (with the exception of the emotional role limitations subscale), and social subscales and respective psychological and social domains of the ULL27. However, the SF-36 vitality and physical role limitations subscales did not correlate very strongly with the physical domain of the ULL27 [15]. Both studies demonstrated moderate correlations between the SF-36 bodily pain subscale and respective physical scales of the lymphedema scales in the expected direction. Similar results were demonstrated between the SF-36 social functioning subscale and respective Lymph- ICF and ULL27 social scales. The Devoogdt et al. [14] study found that the SF-36 mental health subscale was correlated strongly with the Lymph-ICF mental function scale; however, the Viehoff et al. [15] study reported similar findings except for the respective ULL27 psychological scale and SF-36 emotional role limitations. Concurrent validity: divergent One study stated five hypotheses to assess the divergent validity of SF-36 and the Lymph-ICF see Table 2. Three of the five hypotheses were supported. The authors expected the greatest divergence and thus weakest association to be between the Lymph-ICF life and social and the SF-36 physical functioning subscales; however, the lowest correlation was reportedly with SF-36 emotional role limitations. Moreover, Lymph-ICF mobility activities subscale was negatively, but moderately associated with the SF-36 emotional role limitations subscale (q =-0.42) which deviated from the a priori hypothesis [14]. Construct validity Based on the original factor structure of the SF-36, one study utilised Confirmatory Factor Analysis to test the factor structure of four subscales of the SF-36 for their total sample and three sub-groups: African-American; LEP and EP Latina-American. For the total sample, the 4 factors explained 72 % of variance and generally represented the structure of the SF-36. Four distinct factors emerged for each SF-36 subscale with few inconsistencies see Table 1. Although, the four factors of the SF-36 explained between 73 and 75 % of the variance in quality-of-life scores within the respective ethnic and language subgroups, the factor structure of the subscales with the exception of the physical role limitation subscale was less consistent. The general health items loaded onto three factors across the three sub-groups, and each of the items for the bodily pain and social functioning subscales loaded onto one factor among the African-American and LEP Latina-American sub-groups see Table 1 [12]. Exploratory factor analysis data across the total sample and ethnic and language sub-groups were presented for the general health perception items only in one paper [10]. According to the authors descriptions of the results for the other subscales (except for SF-36 social functioning), the factor structure was generally consistent for the total sample. The most consistent factor structure was within the European-American sub-group whereby inconsistencies were found only within the general health and physical functioning subscales. The factor structure of the SF-36 performed similarly within the Asian- and African-American sub-groups. The most inconsistent pattern of factor loadings was within the Latina-American sub-group; good factor structure was identified among the emotional role limitations subscale only [10]. Both studies demonstrate good factor structure of the SF- 36 within the total samples under study; however, factor structures were less consistent within the ethnic and language sub-groups. A few notable discrepancies can be found between the two studies. Within the African-American subgroup, discrepancies can be seen for the factor structure of the physical role limitations, general health and bodily pain subscales. Moreover, within the Latina-American subgroup, the only discrepancy can be seen in the factor structure for the physical role limitations subscale [10, 12]. A further study assessed the factor structure of the SF-12 within a Chinese-American breast cancer survivor sample.

19 Table 2 Study characteristics of papers which provide psychometric information on the SF measures but focussed on other measures a Study Devoogdt et al. [14] Terhorst et al. [16] Viehoff et al. [15] Country Belgium USA The Netherlands Measure(s) of interest Lymphedema Functioning, Disability and Health questionnaire (Lymph-ICF) Breast Cancer Prevention Trial Symptom Checklist (BCPT) Upper limb lymphedema 27-item questionnaire (ULL27) SF-36 Dutch language version SF-36 English language version SF-36 Dutch language version Study-specific questionnaire Aim(s) To assess the validity and reliability of the Lymph-ICF questionnaire To assess the psychometric properties of the BCPT with a sample of breast cancer patients before and after adjuvant therapy Construct validity assessed using the SF-36 To determine the discriminant validity of the presence/ absence of symptoms on the BCPT using the SF-36 Study design Longitudinal survey: baseline at outpatient appointment; follow-up h later to be returned by post. Baseline and follow-up data obtained from a longitudinal cohort study Population Criteria Criteria Criteria Psychometric properties assessed Dutch-speaking breast cancer survivors who had undergone unilateral axillary dissection at least 12 months previously, recruited from hospital-based physiotherapy and breast clinic appointments Breast cancer survivors diagnosed with stages I-IIIa who were part of the Anastrozole use In Menopausal women (AIM) cohort study Sample Sample Sample n = 90 breast cancer patients n = 27 chemotherapy only group; age: mean = 58.9 years; range = years; education: mean = 14.6 years; 81.5 % white ethnicity n = 30 with objective lymphedema; age: mean = 61.2 years; SD = 10.0 years n = 30 with subjective lymphedema; age: mean = 56.7 years; SD = 9.3 years n = 30 with no reported lymphedema; age: mean = 58.3 years; SD = 11.9 years Construct validity (Convergent and Divergent) n = 157 anastrozole only group; age: mean = 61.6 years; range = years; education: mean = 14.8 years; 98.1 % white ethnicity n = 94 chemotherapy and anastrozole combined group; age: mean = 59.0; range = years; education: mean = 14.7 years; 94.7 % white ethnicity Convergent validity hypotheses Discriminant validity Concurrent validity (1) Lymph-ICF physical function and SF-36 bodily pain (2) Lymph-ICF mental function and SF-36 mental health (3) Lymph-ICF household activities and SF-36 physical functioning To translate the ULL27 into Dutch (from French) and determine its psychometric properties in a population of patients with lymphedema To assess the concurrent validity of the ULL27 using the SF-36 Cross-sectional survey and clinical assessment of lymphedema Dutch women with breast cancer with unilateral edema of the upper limb (no distinction made between primary and secondary lymphedema). Patients with progressive disease or infection of the upper limb in the last 2 months were excluded n = 84; age: mean = 59 years; SD = 11.79; onset of edema after surgery: mean = 26 months; SD = months

20 Table 2 continued Study Devoogdt et al. [14] Terhorst et al. [16] Viehoff et al. [15] Country Belgium USA The Netherlands (4) Lymph-ICF mobility activities and SF-36 physical functioning (5) Lymph-ICF life and social activities and SF-36 social functioning Divergent validity hypotheses (1) Lymph-ICF physical function and SF-36 roleemotional and mental health (2) Lymph-ICF mental health and SF-36 physical functioning and physical role limitations (3) Lymph-ICF household activities and SF-36 emotional role limitations and mental health (4) Lymph-ICF mobility activities and SF-36 emotional role limitations and mental health (5) Lymph-ICF life and social activities and SF-36 physical limitations Results Construct validity Discriminant validity Concurrent validity 5 convergent validity hypotheses were supported Low, negative correlations between the symptoms reported on the BCPT and scores on the SF-36 summary component scores at both baseline (range = to 0.016) and 6-month follow-up (range = to ) (1) Lymph-ICF physical function and SF-36 bodily pain (q =-0.52) (2) Lymph-ICF mental function and SF-36 mental health (q =-0.70) (3) Lymph-ICF household activities and SF-36 physical functioning (q =-0.51) (4) Lymph-ICF mobility activities and SF-36 physical functioning (q =-0.62) (5) Lymph-ICF life and social activities and SF-36 social functioning (q =-0.33) 3 of the 5 divergent hypotheses were supported The Dutch ULL27 domains were significantly correlated with most of the respective SF-36 The ULL27 physical domain correlated highly with SF- 36 bodily pain (q = 0.69), general health (q = 0.60) and social functioning (q = 0.55) domains, but not physical role limitations (q = 0.38) or vitality (q = 0.47) domains as would be expected The ULL27 psychological domain correlated highly with SF-36 general health (q = 0.54), vitality (q = 0.55), mental health (q = 0.66) and social functioning (q = 0.51) domains as would be expected, but not the emotional role limitations (q = 0.42) domain The ULL27 social domain correlated highly with SF-36 physical functioning (q = 0.64), general health (q = 0.56) and social functioning (q = 0.45) domains

21 Table 2 continued Study Devoogdt et al. [14] Terhorst et al. [16] Viehoff et al. [15] Country Belgium USA The Netherlands Authors conclusions Quality assessment (1) Lymph-ICF physical function and SF-36 roleemotional (q = 0.03) and mental health (q =-0.14) (2) Lymph-ICF mental health and SF-36 physical functioning (q =-0.24) and physical role limitations (q =-0.25) (3) Lymph-ICF household activities and SF-36 emotional role limitations (q =-0.22) and mental health (q =-0.27) (4) Support for emotional role limitations only and not mental health-lymph-icf mobility activities and SF- 36 emotional role limitations: (q =-0.15) and mental health: (q =-0.42) (5) Unsupported-Lymph-ICF life and social activities and SF-36 physical functioning (q =-0.25); (role limitations emotional had lowest correlation q =- 0.19) Construct validity Discriminant validity Concurrent validity The Lymph-ICF demonstrated good convergent and divergent validity with respective sub-scales of the SF-36 Discriminant validity was reported in the expected direction that a higher number of reported symptoms is associated with lower scores on the SF-36. This finding is supported by other research Construct validity Construct validity Construct validity Poor Fair Fair The lower concurrent validity between the ULL27 physical domain and the respective SF-36 domains may be explained by the focus of lower limb functioning in the SF-36 as compared to upper limb focus in the ULL27 There was good concurrent validity between the psychological and social domains of the ULL27 and respective SF-36 domains Unless where necessary information regarding the SF measures only is reported a

22 The authors utilised exploratory factor analysis at baseline to explore the factor structure of the measure within this population. The factor structure largely mirrored that of the original measure, all MCS items (with one PCS item) and PCS items loaded onto two emergent factors, respectively. Confirmatory Factor Analysis was used to assess how the SF-12 performed in the same population, 1 year later. Two factors emerged, but the pattern of factor loadings reflecting the MCS and PCS items was less consistent, and 58.1 % only of variance was explained [13]. Discriminant validity One study administered the English language SF-36 in order to differentiate between groups of breast cancer survivors with and without lymphedema [11], and a second study used the SF-36 to assess the discriminant validity of the Breast Cancer Prevention Trial Symptom Checklist (BCPT) measure [16]. At baseline and 6-month follow-up, low correlations (range q = to and q = to , respectively) were reported between the SF-36 component summary scores and BCPT scores. The BCPT requires the presence or absence of a number of symptoms related to breast cancer treatment to be reported, and higher scores on the SF-36 indicate better HRQoL. The findings indicated the SF-36 has good discriminant validity [16]. The SF-36 was able to differentiate between survivors with and without lymphedema in the expected direction (i.e. survivors with lymphedema have lower SF-36 scores) in terms of physical component summary score (d = 1.20), physical role limitations (d = 1.02), physical functioning (d = 1.11), emotional role limitations (d = 0.72), vitality (d = 0.74), social functioning (d = 0.60), bodily pain (d = 1.20) and general health (d = 0.69). The SF-36 mental component summary score (d = 0.19) and mental health subscale were not able to differentiate between survivors with and without lymphedema [11]. Discussion Seven studies assessed the psychometric properties of the SF measures within diverse ethnic and language breast cancer survivor samples. Overall, the SF measures were found to have good psychometric properties. Further support for the use of the SF-36 among cancer survivor populations is provided by the assessment of the psychometric properties of the SF-36 within a British, childhood cancer survivor cohort [17]. Internal consistency ranged from acceptable to good across the SF-36 subscales and SF-12 component summary scores within breast cancer survivor populations of varying spoken languages and ethnicities. The social functioning subscale had the lowest internal consistency scores (a = 0.64 and a = 0.68) among African-American breast cancer survivors in two studies; however, the scores were not low enough to warrant cause for concern. The SF-36 and FACT-G were assessed concurrently in two studies within various ethnic and language sub-groups; comparisons between the two studies were, however, limited as one study included only four of the eight SF-36 subscales and included only two similar ethnic and language subgroups. Differences in study design between the two studies may account for some of the discrepancies in concurrent validity results (e.g. SF-36 subscales and FACT measures social/family well-being subscales) among the African- American samples. One of the studies conducted a population-based cross-sectional telephone or postal survey to investigate different recruitment strategies among different ethnic and language groups and to assess the psychometric properties of health-related outcome measures [10], whereas the other study utilised baseline data from a psycho-education intervention study to undertake a secondary assessment of psychometric properties [12]. No further details of the psycho-education intervention are reported in the study or published elsewhere, in particular how the sample was selected. Breast cancer survivors who already have a good knowledge of breast cancer and its impact may have selfselected for the psycho-education intervention compared to survivors with less knowledge; therefore, items on the cancer-specific FACT-G may have more salience for them compared to items on the generic SF-36. A further study assessed the convergent validity of the SF-36 and FLIC to good effect [11]. Given that the SF-36 is a generic measure of health status and the FACT and FLIC are measures specific to cancer populations, it shows promise that the measures seemingly measure the same constructs in diverse ethnic and language breast cancer survivor groups. It would appear that the SF-36 may be a suitable generic alternative to both cancer-specific measures, particularly to make comparisons of the health status of cancer survivors to population norms, the general population or other disease groups. The concurrent validity of respective subscales of the Dutch language SF-36 and lymphedema-specific measures (ULL27 and Lymph-ICF) was assessed for convergent validity in two studies and divergent validity (Lymph-ICF) in one study to good effect. One of the studies found a less strong association between respective physical subscales of the two measures. The authors report that this is likely due to the lower limb focus of the SF-36 e.g. ability to climb a flight of stairs compared to the upper limb focus of the ULL27 [15]. Thus, the SF-36 may be more appropriate for use among survivors with lower limb lymphedema [18], although this would need to be psychometrically assessed. In order to accurately capture the health outcomes of breast

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