Spiritual well-being and its relationship with patient characteristics and other patient-reported outcomes in peritoneal dialysis patients: Findings from the PDOPPS.

BACKGROUND: Spiritual well-being (SWB), an individual's understanding of the meaning and purpose of life, may help patients with chronic or terminal illnesses cope with their diseases. This study aimed to assess SWB in patients on peritoneal dialysis (PD), as well as its relationship with patient characteristics and patient-reported outcomes (PRO). METHODS: The data were obtained from questionnaires that formed part of the PD Outcomes and Practice Patterns Study (PDOPPS). Measures used in this study were SWB scores derived from the WHO quality of life, spirituality, religiousness and personal beliefs (WHOQOL-SRPB) tool including 32 items from eight facets; physical (PCS) and mental component summary (MCS) scores of the 12-Item Short-Form Health Survey (SF-12), Center of Epidemiologic Studies Depression Scale-10 (CES-D-10) scores, burden of kidney disease scores and functional status scores. RESULTS: Overall, 529 out of 848 participants (62%) completely responded to the questionnaires and were included in the analysis. Over two-thirds of PD patients (70%) had moderate or higher SWB scores. The SWB scores were significantly lower in patients with age >65 years and unemployed status. SWB scores positively correlated with higher PCS, MCS, burden of kidney disease scores and functional status scores, while negatively correlated with depression scores by CES-D-10 scale. Patients who reported significant depressive symptoms (CES-D-10 score ≥ 10) had significantly lower SWB scores. CONCLUSION: Better SWB was significantly associated with better health-related QOL (HRQOL) and the absence of depressive symptoms. SWB may be an essential consideration in the delivery of high-quality PD.

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.

BACKGROUND: Cancer not only impairs a patient's physical and psychosocial functional behaviour, but also contributes to negative impact on family members' health related quality of life. Currently, there is an absence of a relevant tool in Thai with which to measure such impact. The aim of this study was to translate and validate the Family Reported Outcome Measure (FROM-16) in Thai cancer patients' family members. METHODS: Thai version of FROM-16 was generated by interactive forward-backward translation process following standard guidelines. This was tested for psychometric properties including reliability and validity, namely content validity, concurrent validity, known group validity, internal consistency, exploratory and confirmatory factor analysis. Construct validity was examined by comparing the Thai FROM-16 version with the WHOQOL-BREF-THAI. RESULTS: The internal consistency reliability was strong (Cronbach's alpha = 0.86). A Negative moderate correlation between the Thai FROM-16 and WHOQOL-BREF-THAI was observed (r = - 0.4545, p < 0.00), and known group validity was proved by a statistically significant higher score in family members with high burden of care and insufficient income. The factor analysis supported both 3-factor and 2-factor loading model with slight difference when compared with the original version. CONCLUSIONS: The Thai FROM-16 showed good reliability and validity in Thai family members of patients with cancer. A slight difference in factor analysis results compared to the original version could be due to cross-culture application.

Assisted peritoneal dialysis performed by caregivers and its association with patient outcomes.

BACKGROUND: Although caregivers allow peritoneal dialysis (PD) patients with disabilities the opportunity to perform PD, it is crucial to clarify the safety and effectiveness of assisted PD performed by caregivers compared to self-PD. METHODS: PD patients from 22 PD centres in Thailand were prospectively followed in the Peritoneal Dialysis Outcomes and Practice Patterns Study during 2016-2017. Patients receiving assisted PD performed by caregivers were matched 1:1 with self-PD patients using propensity scores calculated by logistic regression. The associations between assisted PD and risk of mortality, peritonitis and permanent transfer to haemodialysis (HD) were assessed by multivariable competing risk regression. RESULTS: Of 778 eligible patients, 447 (57%) required assisted PD performed by caregivers. Most of the caregivers were family members (98%), while the rest were non-family paid caregivers (2%). Patient factors associated with assisted PD were older age, female gender, lower educational level, cardiovascular comorbidities, diabetes, automated PD modality, poorer functional status and lower blood chemistries (albumin, creatinine, sodium, potassium and phosphate). After 1:1 matching, the baseline characteristics were adequately matched, and 269 patients in each group were analysed. Compared with self-PD, assisted PD was significantly associated with an increased risk of all-cause mortality (adjusted sub-hazard ratio: 2.15, 95% confidence interval: 1.24-3.74). There were no differences in the occurrences of peritonitis and permanent HD transfer between the groups. CONCLUSIONS: Assisted PD was required by more than half of Thai PD patients and was independently associated with a higher mortality risk. This may reflect causal effect or confounding by indication.

Glucose Tolerance Test and Pharmacokinetic Study of Kaempferia parviflora Extract in Healthy Subjects.

Kaempferia parviflora Wall. ex Baker (KP), Krachaidam in Thai or Thai ginseng, is a herbal medicine that has many potential pharmacological effects. The effect of KP extract on blood glucose level in rodent was reported. This study focused on the oral glucose tolerance test and pharmacokinetic study in healthy volunteers administered with KP extract (90 and 180 mg/day, placebo). The oral glucose tolerance tests were performed at baselines and 28-days of administration. The pharmacokinetics were determined after a single dose administration of the tested products using 3,5,7,3',4'-pentamethoxyflavone (PMF) and 5,7,4'-trimethoxylflavone (TMF) as markers. The results showed that glucose metabolism via oral glucose tolerance test was not affected by KP extract. Blood glucose levels of volunteers at 120 min after glucose loading were able to be returned to initial levels in placebo, KP 90 mg/day, and KP 180 mg/day groups both at baseline and 28-days of administration. The results of the pharmacokinetic study revealed that only TMF and PMF, but not 5,7-dimethoxyflavone (DMF) levels could be detected in human blood. The given doses of KP extract at 90 and 180 mg/day showed a linear dose-relationship of blood PMF concentration whereas blood TMF was detected only at high given dose (180 mg/day). The half-lives of PMF and TMF were 2-3 h. The maximum concentration (Cmax), area under the curve of blood concentration and time (AUC), and time to maximum concentration (Tmax) values of PMF and TMF estimated for the 180 mg/day dose were 71.2 ± 11.3, 63.0 ± 18.0 ng/mL; 291.9 ± 48.2, 412.2 ± 203.7 ng∙h/mL; and 4.02 ± 0.37, 6.03 ± 0.96 h, respectively. PMF was quickly eliminated with higher Ke and Cl than TMF at the dose of 180 mg/day of KP extract. In conclusion, the results demonstrated that KP extract had no effect on the glucose tolerance test. In addition, this is the first demonstration of the pharmacokinetic parameters of methoxyflavones of KP extract in healthy volunteers. The data suggest the safety of the KP extract and will be of benefit for further clinical trials using KP extract as food and sport supplements as well as a drug in health product development.

The Association of Functional Status with Mortality and Dialysis Modality Change: Results from the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

BACKGROUND: Little is known about the prevalence of functional impairment in peritoneal dialysis (PD) patients, its variation by country, and its association with mortality or transfer to hemodialysis. METHODS: A prospective cohort study was conducted in PD patients from 7 countries in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) (2014 - 2017). Functional status (FS) was assessed by combining self-reports of 8 instrumental and 5 basic activities of daily living, using the Lawton-Brody and the Katz questionnaires. Summary FS scores, ranging from 1.25 (most dependent) to 13 (independent), were based on the patient's ability to perform each activity with or without assistance. Logistic regression was used to estimate the odds ratio (OR; 95% confidence interval [CI]) of a FS score < 11 comparing each country with the United States (US). Cox regression was used to estimate the hazard ratio (HR; 95% CI) for the effect of a low FS score on mortality and transfer to hemodialysis, adjusting for case mix. RESULTS: Of 2,593 patients with complete data on FS, 48% were fully independent (FS = 13), 32% had a FS score 11 to < 13, 14% had a FS score 8 to < 11, and 6% had a FS score < 8. Relative to the US, low FS scores (< 11; more dependent) were more frequent in Thailand (OR = 10.48, 5.90 - 18.60) and the United Kingdom (UK) (OR = 3.29, 1.77 - 6.08), but similar in other PDOPPS countries. The FS score was inversely and monotonically associated with mortality but not with transfer to hemodialysis; the HR, comparing a FS score < 8 vs 13, was 4.01 (2.44 - 6.61) for mortality and 0.91 (0.58 - 1.43) for transfer to hemodialysis. CONCLUSION: Regional differences in FS scores observed across PDOPPS countries may have been partly due to differences in regional patient selection for PD. Functional impairment was associated with mortality but not with permanent transfer to hemodialysis.

The validity of A new practical quality of life measure in patients on renal replacement therapy.

OBJECTIVE: A new quality of life measure, apart of the National Health and Welfare 2003 survey, is a promising tool for outcome evaluation of clinical practice due to its brevity, validity, reliability, and providing easy interpretation against general population norm-based scores. The measure consisting of 9-items, and so called 9-item Thai Health status Assessment Instrument (9-THAI) was used to assess its validity and reliability in patients on renal replacement therapy (RRT). MATERIAL AND METHOD: Three hundred and two patients on RRT who visited Srinagarind Hospital from March to May 2005 were studied Convergent and divergent validity were assessed using SF-36 as the concurrent measure. Concurrent validity was also assessed using hematocrit level and hospitalization history in the last year as concurrent clinical measures. Test-retest reliability was studied by repeated measure within one 1 month. Responsiveness of 9-THAI was studied in patients who reported health improvement. RESULTS: Results of correlations between 9-THAI and SF-36 domains were as hypothesized 9-THAI scores were significantly correlated with hematocrit level and hospitalization history. The results confirmed the validity of 9-THAI for use as a quality of life measure. Intraclass correlation coefficients of 9-THAI scores in stable patients were satisfactory. Among patients on RRT who reported overall health improvement, 9-THAI scores significantly increased, thus adding further evidence of the responsiveness of 9-THAI. CONCLUSION: The 9-THAI is a valid and reliable generic health status measure that can be used as an ideal core in a battery of quality of life measures in clinical practice for patients on RRT.

Melatonin in patients with cancer receiving chemotherapy: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: The MIRCIT trial was a randomized, double-blind, placebo-controlled study of advanced Non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients were randomized to receive 10 mg or 20 mg of melatonin or placebo. Assessment of health-related quality of life (HRQoL) was completed at baseline, and at 2, 3 and 7 months. Survival and adverse events were collected. DNA damage marker 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG) was measured during the first three months of chemotherapy. RESULTS: Patients in the melatonin-treated group had better adjusted HRQoL scores, with a slightly significantly better score (2.69 points, 95% confidence interval (CI)=0.01-5.38, p=0.049) being found in social well-being. Median survival was 7.3 months (95% CI=3.42-11.14) without significant difference. A great amont of DNA damage marker was observed in the placebo-treated group, and this was associated with lower survival (r(2)=-0.656, p=0.02), implying the protective effect of melatonin in healthy cells. CONCLUSION: Melatonin in combination with chemotherapy did not affect survival and adverse events of advanced patients with NSCLC, but there was a trend for better HRQoL.