| Literature DB >> 31417242 |
Nicoletta Riva1, Christian Borg Xuereb2, Michael Makris3, Walter Ageno4, Alex Gatt1.
Abstract
Purpose: Anticoagulant therapy has an impact on the health-related quality of life, as it is a chronic treatment for most clinical indications and also requires some lifestyle changes. Since there was no validated questionnaire available in the Maltese language, the aim of our study was to translate and validate the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2). Patients and methods: The PACT-Q2 explores two dimensions (convenience and anticoagulant treatment satisfaction). Forward and backward translations were performed. The Maltese version of the PACT-Q2 was administered to 174 patients on warfarin treatment enrolled from different anticoagulation clinics in Malta. Reliability was assessed through internal consistency (Cronbach's alpha) and test-retest (intraclass correlation coefficient [ICC]). Validity was assessed through floor/ceiling effect, factor analysis (root mean square error of approximation [RMSEA], standardized root mean squared residual [SRMR], goodness-of-fit index [GFI], adjusted goodness-of-fit index [AGFI], comparative fit index [CFI]), subscales correlation and known-group validity.Entities:
Keywords: atrial fibrillation; psychometrics; quality of life; surveys and questionnaires; venous thromboembolism; warfarin
Year: 2019 PMID: 31417242 PMCID: PMC6593733 DOI: 10.2147/PPA.S207498
Source DB: PubMed Journal: Patient Prefer Adherence ISSN: 1177-889X Impact factor: 2.711
Characteristics of patients who completed the Maltese version of the PACT-Q2
| N of patients | 174 |
|---|---|
| Age (years), mean (SD) | 70 (10.1) |
| Males, n/N (%) | 82/174 (47.1%) |
| Living alone, n/N (%) | 31/174 (17.8%) |
| Primary school education only, n/N (%) | 108/174 (62.1%) |
| Paid employment (full- or part-time), n/N (%) | 18/174 (10.3%) |
| Anticoagulant indications: atrial fibrillation, n/N (%) | 122/174 (70.1%) |
| Anticoagulant treatment duration: >5 years, n/N (%) | 76/174 (43.7%) |
| INR in range at enrolment, n/N (%) | 99/174 (56.9%) |
| Good anticoagulation control (TTR ≥70%) in the previous 12 months, n/N (%) | 96/170 (56.5%) |
| Hospitalisation in the previous 12 months, n/N (%) | 86/170 (50.6%) |
| History of bleeding (self-reported), n/N (%) | 63/174 (36.2%) |
Abbreviations: INR, international normalized ratio; SD, standard deviation; TTR, time within therapeutic range.
Internal consistency of the Maltese and English versions of the PACT-Q2
| PACT-Q2 | Maltese version | English version | |||||
|---|---|---|---|---|---|---|---|
| Item | Cronbach’s alpha coefficient | Item-total correlation | Cronbach’s alpha if item deleted | Cronbach’s alpha coefficient | Item-total correlation | Cronbach’s alpha if item deleted | |
| 0.86 | 0.86 | ||||||
| 0.63 | 0.84 | 0.56 | 0.84 | ||||
| 0.72 | 0.83 | 0.68 | 0.84 | ||||
| 0.60 | 0.84 | 0.65 | 0.84 | ||||
| 0.65 | 0.84 | 0.53 | 0.85 | ||||
| 0.49 | 0.85 | 0.51 | 0.85 | ||||
| 0.57 | 0.84 | 0.54 | 0.84 | ||||
| 0.58 | 0.84 | 0.53 | 0.84 | ||||
| 0.54 | 0.84 | 0.61 | 0.84 | ||||
| 0.65 | 0.84 | 0.62 | 0.84 | ||||
| 0.32 | 0.86 | 0.23 | 0.86 | ||||
| 0.34 | 0.86 | 0.39 | 0.86 | ||||
| 0.42 | 0.85 | 0.52 | 0.84 | ||||
| 0.36 | 0.85 | 0.55 | 0.84 | ||||
| 0.62 | 0.75 | ||||||
| 0.40 | 0.56 | 0.41 | 0.73 | ||||
| 0.31 | 0.66 | 0.28 | 0.79 | ||||
| 0.31 | 0.59 | 0.36 | 0.74 | ||||
| 0.33 | 0.59 | 0.53 | 0.71 | ||||
| 0.35 | 0.58 | 0.61 | 0.69 | ||||
| 0.48 | 0.57 | 0.72 | 0.68 | ||||
| 0.56 | 0.56 | 0.69 | 0.68 | ||||
Results of the confirmatory factor analysis
| Fit parameters | Reference values | Maltese version of the PACT-Q2 | English version of the PACT-Q2 |
|---|---|---|---|
| RMSEA | ≤0.08 | 0.09 | 0.07 |
| SRMR | ≤0.10 | 0.10 | 0.08 |
| GFI | ≥0.90 | 0.82 | 0.80 |
| AGFI | ≥0.90 | 0.78 | 0.84 |
| CFI | ≥0.90 | 0.79 | 0.88 |
Abbreviations: Legend, AGFI, adjusted goodness-of-fit index; CFI, comparative fit index; GFI, goodness-of-fit index; RMSEA, root mean square error of approximation; SRMR, standardized root mean squared residual.
Correlation between the PACT-Q2 and sociodemographic or clinical characteristics
| Variable | Correlation coefficient for the Maltese version | Correlation coefficient for the English version | ||
|---|---|---|---|---|
| Convenience | Satisfaction | Convenience | Satisfaction | |
| Increasing age | 0.05 (0.53) | 0.02 (0.81) | 0.34 (<0.0001) | 0.14 (0.08) |
| Male sex | 0.09 (0.26) | 0.03 (0.68) | 0.27 (0.001) | 0.19 (0.02) |
| Living alone | 0.05 (0.54) | −0.11 (0.14) | −0.07 (0.37) | 0.05 (0.55) |
| Primary school education only | −0.01 (0.95) | −0.07 (0.36) | −0.02 (0.84) | −0.11 (0.16) |
| Paid (full- or part-time) employment | −0.09 (0.24) | 0.04 (0.56) | −0.22 (0.006) | −0.15 (0.07) |
| Atrial fibrillation | −0.01 (0.94) | 0.04 (0.58) | 0.09 (0.27) | 0.01 (0.91) |
| Anticoagulant treatment duration >5 years | 0.03 (0.73) | 0.07 (0.36) | 0.05 (0.57) | 0.01 (0.92) |
| INR in range at enrolment | 0.05 (0.49) | 0.05 (0.43) | 0.07 (0.36) | −0.15 (0.07) |
| Good anticoagulation control (TTR ≥70%) in the previous 12 months | 0.06 (0.43) | 0.12 (0.12) | 0.04 (0.64) | −0.03 (0.71) |
| Hospitalisation in the previous 12 months | −0.10 (0.21) | −0.03 (0.70) | −0.18 (0.03) | 0.05 (0.58) |
| History of bleeding (self-reported) | −0.16 (0.08) | −0.21 (0.01) | −0.17 (0.03) | −0.12 (0.11) |
Note: A negative correlation means lower satisfaction.
Abbreviations: INR, international normalized ratio; TTR, time within therapeutic range.
Details of the intra-language correlation: score differences on re-administration of the PACT-Q2 (time 2 minus time 1) and intraclass correlation coefficients
| Mean score difference (SD) | Min score difference | Max score difference | ICC | |
|---|---|---|---|---|
| PACT-Q2 convenience | −0.1 (3.2) | −6 | 6 | 0.87 |
| PACT-Q2 satisfaction | 0.1 (4.1) | −7 | 8 | 0.40 |
| PACT-Q2 convenience | 0.9 (3.0) | −3 | 7 | 0.87 |
| PACT-Q2 satisfaction | 2.3 (3.6) | −1 | +10 | 0.60 |
Note: For both subscales, the original scores were considered (not rescaled). Items in the convenience subscale were reversed.
Abbreviations: ICC, intraclass correlation coefficient; SD, standard deviation.
Response distribution for each PACT-Q2 item and summary statistics
| PACT-Q2 item | Maltese version | English version | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Response category (%) | Mean (SD) | Response category (%) | Mean (SD) | |||||||||
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | |||
| 1.2 | 5.2 | 4.0 | 12.1 | 4.6 (0.9) | 0.6 | 1.3 | 5.7 | 14.0 | 4.7 (0.7) | |||
| 2.9 | 6.3 | 8.6 | 20.1 | 4.3 (1.1) | 0.0 | 5.1 | 6.4 | 16.6 | 4.6 (0.8) | |||
| 4.0 | 5.8 | 6.3 | 24.1 | 4.3 (1.1) | 0.0 | 2.6 | 9.6 | 26.1 | 4.5 (0.8) | |||
| 5.2 | 12.6 | 8.6 | 24.1 | 4.0 (1.2) | 2.6 | 11.5 | 19.1 | 26.8 | 3.9 (1.1) | |||
| 2.9 | 10.3 | 15.5 | 21.8 | 4.0 (1.2) | 1.3 | 8.3 | 19.8 | 29.3 | 4.0 (1.0) | |||
| 2.9 | 8.1 | 4.0 | 10.3 | 4.5 (1.1) | 0.6 | 2.6 | 7.6 | 21.0 | 4.5 (0.8) | |||
| 1.7 | 4.6 | 9.8 | 18.4 | 4.4 (1.0) | 1.9 | 3.8 | 8.3 | 26.1 | 4.4 (0.9) | |||
| 1.2 | 4.0 | 7.5 | 14.4 | 4.5 (0.9) | 1.3 | 6.4 | 8.9 | 27.4 | 4.3 (1.0) | |||
| 0.6 | 4.0 | 4.6 | 6.9 | 4.7 (0.8) | 0.6 | 1.9 | 2.6 | 17.2 | 4.7 (0.7) | |||
| 5.2 | 8.1 | 5.2 | 17.8 | 4.3 (1.2) | 1.3 | 3.2 | 3.8 | 13.4 | 4.6 (0.8) | |||
| 11.5 | 17.8 | 29.5 | 24.1 | 3.4 (1.4) | 8.3 | 17.8 | 19.1 | 26.1 | 3.5 (1.3) | |||
| 2.3 | 4.0 | 6.9 | 10.9 | 4.5 (1.0) | 0.0 | 4.5 | 10.8 | 14.0 | 4.5 (0.9) | |||
| 2.3 | 8.6 | 10.9 | 25.3 | 4.2 (1.1) | 0.6 | 2.6 | 7.0 | 28.0 | 4.5 (0.8) | |||
| 2.3 | 2.9 | 27.0 | 57.5 | 10.3 | 3.7 (0.8) | 6.4 | 8.3 | 14.6 | 39.5 | 3.8 (1.2) | ||
| 14.9 | 6.9 | 16.7 | 10.3 | 2.2 (1.5) | 16.6 | 19.1 | 14.0 | 7.6 | 2.3 (1.3) | |||
| 4.0 | 5.8 | 50.6 | 28.7 | 10.9 | 3.4 (0.9) | 0.6 | 3.2 | 54.1 | 21.7 | 3.6 (0.9) | ||
| 0.6 | 2.9 | 12.6 | 72.4 | 11.5 | 3.9 (0.6) | 0.6 | 1.9 | 11.5 | 64.3 | 4.0 (0.7) | ||
| 0.0 | 5.8 | 9.8 | 71.3 | 13.2 | 3.9 (0.7) | 1.3 | 5.1 | 12.7 | 53.5 | 4.0 (0.9) | ||
| 0.0 | 0.6 | 6.3 | 81.6 | 11.5 | 4.0 (0.4) | 1.3 | 0.6 | 7.0 | 68.8 | 4.1 (0.7) | ||
| 0.0 | 0.0 | 5.8 | 78.7 | 4.1 (0.5) | 1.3 | 1.3 | 7.6 | 64.3 | 4.1 (0.7) | |||
Notes: Numbers in bold in the response category section indicate significant floor or ceiling effect. * Items of the convenience subscale (B1 to C2) are reversed.
Results of the 2-factor analysis
| Maltese version | English version | |||
|---|---|---|---|---|
| Item | Convenience | Satisfaction | Convenience | Satisfaction |
| 0.09 | 0.06 | |||
| 0.26 | 0.34 | |||
| 0.07 | 0.06 | |||
| −0.03 | −0.03 | |||
| 0.04 | 0.10 | |||
| −0.08 | 0.16 | |||
| 0.32 | 0.18 | |||
| 0.13 | 0.25 | |||
| 0.07 | 0.05 | |||
| 0.09 | 0.15 | |||
| 0.07 | 0.11 | |||
| −0.08 | 0.08 | |||
| 0.03 | 0.11 | |||
| −0.06 | 0.08 | |||
| −0.36 | −0.07 | |||
| 0.10 | 0.15 | |||
| 0.20 | 0.38 | |||
| 0.16 | 0.14 | |||
| 0.03 | 0.17 | |||
| −0.10 | 0.18 | |||
Notes: Numbers in bold indicate the highest loading of each factor, which is therefore likely to explore that dimension. * Items of the convenience subscale (B1 to C2) are reversed.