Displaying publications 1 - 20 of 39 in total

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  1. You R, Liu J, Wu DB, Qian X, Lyu B, Zhang Y, et al.
    Cancer Manag Res, 2019;11:10239-10248.
    PMID: 31824194 DOI: 10.2147/CMAR.S219722
    Objective: The purpose of this study was to evaluate the cost-effectiveness of the combined use of afatinib and epidermal growth factor receptor (EGFR) testing versus gemcitabine-cisplatin as the first-line treatment for patients with non-small cell lung cancer (NSCLC) in China.

    Methods: A decision-analytic model, based on clinical phase III trials, was developed to simulate patient transitions. Direct costs were estimated from the perspective of the Chinese healthcare system. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICER) were calculated over a 5-year lifetime horizon. Model robustness was conducted in sensitivity analyses.

    Results: For the base case, EGFR mutation testing followed by afatinib treatment for advanced NSCLC increased 0.15 QALYs compared with standard chemotherapy at an additional cost of $5069.12. The ICER for afatinib maintenance was $33,416.39 per QALY gained. The utility of PFS and the cost of afatinib had the most important impact on the ICER. Scenario analyses suggested that when a patient assistance program (PAP) was available, ICER decreased to $22,972.52/QALY lower than the willingness-to-pay (WTP) threshold of China ($26,508/QALY).

    Conclusion: Our results suggest that gene-guided maintenance therapy with afatinib with the PAP might be a cost-effective treatment option compared with gemcitabine - cisplatin in China.

  2. You R, Zhang Y, Wu DB, Liu J, Qian X, Luo N, et al.
    Front Pharmacol, 2020;11:456.
    PMID: 32425768 DOI: 10.3389/fphar.2020.00456
    Objective: This study aims to estimate the cost-effectiveness of yearly intravenous zoledronic acid treatment versus weekly oral alendronate for postmenopausal osteoporotic women in China.

    Methods: We used a Markov microsimulation model to compare the cost-effectiveness of zoledronic acid with alendronate in Chinese postmenopausal osteoporotic women with no fracture history at various ages of therapy initiation from health care payer perspective.

    Results: The incremental cost-effectiveness ratios (ICERs) for the zoledronic acid versus alendronate were $23,581/QALY at age 65 years, $17,367/QALY at age 70 years, $14,714/QALY at age 75 years, and $12,169/QALY at age 80 years, respectively. In deterministic sensitivity analyses, the study demonstrated that the two most impactful parameters were the annual cost of zoledronic acid and the relative risk of hip fracture with zoledronic acid. In probabilistic sensitivity analyses, the probabilities of zoledronic acid being cost-effective compared with alendronate were 70-100% at a willingness-to-pay of $29,340 per QALY.

    Conclusions: Among postmenopausal osteoporotic women in China, zoledronic acid therapy is cost-effective at all ages examined from health care payer perspective, compared with weekly oral alendronate. In addition, alendronate treatment is shown to be dominant for patients at ages 65 and 70 with full persistence. This study will help clinicians and policymakers make better decisions about the relative economic value of osteoporosis treatments in China.

  3. Wu DB, Chaiyakunapruk N, Chong HY, Beutels P
    Vaccine, 2015 Mar 30;33(14):1633-58.
    PMID: 25681663 DOI: 10.1016/j.vaccine.2015.01.081
    BACKGROUND: Seven-valent pneumococcal conjugate vaccines (PCV7) have been used in children for more than a decade. Given the observed increase in disease caused by pneumococcal serotypes not covered by PCV7, an increasing number of countries are switching from 7-valent to 10- and 13-valent PCVs ("PCV10" and "PCV13"). Economic evaluations are important tools to inform decisions and price negotiations to make such a switch.
    OBJECTIVE: This review aims to provide a critical assessment of economic evaluations involving PCV10 or PCV13, published since 2006.
    METHODS: We searched Scopus, ISI Web of Science (SCI and SSCI) and Pubmed to retrieve, select and review relevant studies, which were archived between 1st January 2006 and 31st January 2014. The review protocol involved standard extraction of assumptions, methods, results and sponsorships from the original studies.
    RESULTS: Sixty-three economic evaluations on PCVs published since January 2006 were identified. About half of these evaluated PCV10 and/or PCV13, the subject of this review. At current prices, both PCV13 and PCV10 were likely judged preferable to PCV7. However, the combined uncertainty related to price differences, burden of disease, vaccine effectiveness, herd and serotype replacement effects determine the preference base for either PCV10 or PCV13. The pivotal assumptions and results of these analyses also depended on which manufacturer sponsored the study.
    CONCLUSION: A more thorough exploration of uncertainty should be made in future analyses on this subject, as we lack understanding to adequately model herd and serotype replacement effects to reliably predict the population impact of PCVs. The introduction of further improved PCVs in an environment of evolving antibiotic resistance and under the continuing influence of previous PCVs implies that the complexity and data requirements for relevant analyses will further increase. Decision makers using these analyses should not just rely on an analysis from a single manufacturer.
    KEYWORDS: Cost-effectiveness; Cost–benefit; Pneumococcal conjugate vaccine; Streptococcus pneumoniae
  4. Wu DB, Hussain S, Mak V, Lee KK
    Value Health, 2014 Nov;17(7):A382.
    PMID: 27200852 DOI: 10.1016/j.jval.2014.08.2625
    OBJECTIVES. Osteoporotic fractures are common in older adults and are often associated with high morbidity and mortality. As the incidence increases with age, it is natural that osteoporotic fractures have become a major health problem worldwide. Increasing number of patients with osteoporotic fracture will have a serious economic impact on the patient themselves and the society. The objective of this study is to study the cost-effectiveness of strontium ranelate compared to alendronate for patients with post-menopausal osteoporotic fractures in Malaysia.
    METHODS. A Markov model was developed to project clinical and economic benefits of strontium in a hypothetical cohort of patients (N=1,000) over a 5-year time horizon. This study was conducted from a payer perspective. Model parameters including transition probabilities and costs of treating fracture at various sites were Malaysia-specific. Drug costs were obtained from a public teaching hospital in Kuala Lumpur. Utilities were derived from previous literatures and efficacy data were derived from two pivotal trials, i. e. SOTI and TROPOS trials. Outcomes were presented as cost per quality-adjusted life year (QALY) gained. A discount rate of 3% was applied. Both 1-way and multivariate probabilistic sensitivity analyses were undertaken to evaluate robustness of results.
    RESULTS. Compared to alendronate, strontium could prevent 328 wrist, 192 hip, 7 vertebra and 115 multiple fractures respectively over 5 years, which was translated into 27.9 QALYs gained. Using strontium can lead to cost reduction of MYR1,416,595 (USD442,685), MYR478,257 (USD149,455), MYR22,784 (USD7,120) and MYR61,883 (USD113,088) due to reduced episodes of fractures at wrist/hip/vertebra/multiple sites respectively. The total reduction of direct medical costs of MYR2,279,519 (USD712,349) was larger than the extra drug cost, hence making strontium a cost-saving therapy.
    CONCLUSIONS. It was shown that strontium appeared to be more cost-effective compared to alendronate and hence should be recommended in the public sector in Malaysia.
  5. Wu DB, Roberts CS, Huang YC, Chien L, Fang CH, Chang CJ
    J Med Econ, 2014 May;17(5):312-9.
    PMID: 24575941 DOI: 10.3111/13696998.2014.898644
    Invasive pneumococcal disease (IPD) and pneumococcal pneumonia cause substantial morbidity and mortality worldwide. This retrospective study was conducted to estimate the disease burden from pneumococcal disease in older adults in Taiwan from a health insurer's perspective.
  6. Wu DB, Lee EH, Chung WS, Chow DP, Lee VW, Wong MC, et al.
    Psychiatry Res, 2013 Dec 30;210(3):745-50.
    PMID: 24012164 DOI: 10.1016/j.psychres.2013.07.012
    Schizophrenia is one of the most expensive psychiatric illnesses. This study compared retrospectively health-care resources consumed 12 months before and 24 months after risperidone long-acting injection (RLAI) treatment in Hong Kong. A mirror-image analysis was conducted using data (N=191) from three public hospitals in Hong Kong from 2003 to 2007. The main outcome measure was hospitalisation cost. Other secondary outcomes such as hospitalisation episodes, outpatient visits and adverse events were also compared. A predictive model was established using linear regression based on generalised estimating equations. Analysis showed that RLAI was associated with a reduction in hospitalisation cost by HK$10,001,390 (24.7%) (HK$40,418,694 vs. HK$30,417,303; P-value <0.05). Days of hospitalisation were reduced by 1538 days (10.1%) (15,271 vs. 13,733; P-value <0.05). The predictive model estimated that the hospitalisation cost of patients using RLAI was only 11.1% (3.1-3.93%, 95% confidence interval (CI)) compared to those receiving conventional antipsychotics combined with oral risperidone. Cost of hospitalisation was significantly reduced after RLAI therapy. However, results should be considered as indicative or suggestive only, due to potential channelling bias where certain drug regimens are preferentially prescribed to patients with particular conditions. The findings from our study may be useful in health-care decision making considering treatment options for schizophrenia in resource-limited settings.
  7. Wu DB, Roberts C, Lee VW, Hong LW, Tan KK, Mak V, et al.
    Hum Vaccin Immunother, 2016;12(2):403-16.
    PMID: 26451658 DOI: 10.1080/21645515.2015.1067351
    Pneumococcal disease causes large morbidity, mortality and health care utilization and medical and non-medical costs, which can all be reduced by effective infant universal routine immunization programs with pneumococcal conjugate vaccines (PCV). We evaluated the clinical and economic benefits of such programs with either 10- or 13-valent PCVs in Malaysia and Hong Kong by using an age-stratified Markov cohort model with many country-specific inputs. The incremental cost per quality-adjusted life year (QALY) was calculated to compare PCV10 or PCV13 against no vaccination and PCV13 against PCV10 over a 10-year birth cohort's vaccination. Both payer and societal perspectives were used. PCV13 had better public health and economic outcomes than a PCV10 program across all scenarios considered. For example, in the base case scenario in Malaysia, PCV13 would reduce more cases of IPD (+2,296), pneumonia (+705,281), and acute otitis media (+376,967) and save more lives (+6,122) than PCV10. Similarly, in Hong Kong, PCV13 would reduce more cases of IPD cases (+529), pneumonia (+172,185), and acute otitis media (+37,727) and save more lives (+2,688) than PCV10. During the same time horizon, PCV13 would gain over 74,000 and 21,600 additional QALYs than PCV10 in Malaysia and Hong Kong, respectively. PCV13 would be cost saving when compared against similar program with PCV10, under both payer and societal perspective in both countries. PCV13 remained a better choice over PCV10 in multiple sensitivity, scenario, and probabilistic analyses. PCV13s broader serotype coverage in its formulation and herd effect compared against PCV10 were important drivers of differences in outcomes.
  8. Wu DB, Yee CH, Ng CF, Lee SWH, Chaiyakunapruk N, Chang YS, et al.
    Front Pharmacol, 2018;9:1078.
    PMID: 30386234 DOI: 10.3389/fphar.2018.01078
    Background: Lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) is a common condition affecting men. Studies have shown that the prevalence of LUTS/BPH increases with age, which will cause considerable economic burden to the healthcare system and society. The aim of the present study was to evaluate the long term cost effectiveness of dutasteride and tamsulosin therapy compared to tamsulosin alone in men with BPH in Hong Kong. Methods: A Markov decision model was constructed to estimate the economic impact from a healthcare payers' perspective, which only included direct costs. Analyses were conducted for a 4-year time frame. Results: When compared to tamsulosin alone, combination therapy was more expensive but also more effective in preventing complications and reduced the need for surgery. Over life-time projection suggest that combination therapy will be cost-effective if the willingness-to pay threshold of USD 20,000. Conclusion: Findings of this study found that combination therapy of tamsulosin and dutasteride was more cost-effective compared to tamsulosin alone across a wide range of scenario.
  9. Wong WP, Coles J, Chambers R, Wu DB, Hassed C
    J Alzheimers Dis Rep, 2017 Dec 02;1(1):181-193.
    PMID: 30480237 DOI: 10.3233/ADR-170031
    Background: The current lack of an effective cure for dementia would exacerbate its prevalence and incidence globally. Growing evidence has linked mindfulness to cognitive and psychological improvements that could be relevant for mild cognitive impairment (MCI).

    Objective: To investigate whether mindfulness practice can improve health outcomes of MCI.

    Methods: The study is the first longitudinal mixed-methods observational study with a one-year follow-up period, that customized an eight-week group-based mindfulness training program for older adults with MCI (n = 14). Measures included cognitive function, psychological health, trait mindfulness, adherence to mindfulness practice, and everyday activities functioning as assessed at pre-intervention, post-intervention, and one-year follow-up. Repeated measures ANOVAs, Pearson's correlation analyses, and Mann-Whitney U tests were performed.

    Results: The MCI participants showed significant improvements in cognitive function (p 

  10. Toh LS, Lai PS, Wu DB, Wong KT, Low BY, Tan AT, et al.
    Patient Prefer Adherence, 2014;8:1365-81.
    PMID: 25328386 DOI: 10.2147/PPA.S65718
    Purpose: To develop and validate the English version of the Satisfaction Questionnaire for Osteoporosis Prevention (SQOP) in Malaysia.
    Methods: The SQOP was modified from the Osteoporosis Patient Satisfaction Questionnaire and developed based on literature review and patient interviews. Face and content validity were established via an expert panel. The SQOP consists of two sections: clinical services and types of counseling. There were 23 items in total, each with a five-point Likert-type response. Satisfaction score was calculated by converting the total score to a percentage. A higher score indicates higher satisfaction. English speaking, non-osteoporotic, postmenopausal women aged 50 years were included in the study. Participants were randomized to either the control or intervention group. Intervention participants were provided counseling, whereas control participants received none. Participants answered the SQOP at baseline and 2 weeks later.
    Results: A total of 140 participants were recruited (control group: n=70; intervention group: n=70). No significant differences were found in any demographic aspects. Exploratory factor analysis extracted seven domains. Cronbach’s α for the domains ranged from 0.531–0.812. All 23 items were highly correlated using Spearman’s correlation coefficient 0.469–0.996 (P<0.05), with no significant change in the control group’s overall test–retest scores, indicating that the
    SQOP achieved stable reliability. The intervention group had a higher score than the control group (87.91±5.99 versus 61.87±8.76; P<0.05), indicating that they were more satisfied than control participants. Flesch reading ease was 62.9.
    Conclusion: The SQOP was found to be a valid and reliable instrument for assessing patients’ satisfaction towards an osteoporosis screening and prevention service in Malaysia.
    Keywords: patient satisfaction, randomized controlled trial, postmenopausal women, screening
    Study site: primary care clinic, tertiary hospital, Malaysia
  11. Toh LS, Lai PS, Wu DB, Wong KT, Low BY, Anderson C
    PLoS One, 2015;10(5):e0124553.
    PMID: 25938494 DOI: 10.1371/journal.pone.0124553
    Objectives: To develop and validate Osteoporosis Prevention and Awareness Tool (OPAAT) in Malaysia.
    Methods: The OPAAT was modified from the Malaysian Osteoporosis Knowledge Tool and developed from an exploratory study on patients. Face and content validity was established by an expert panel. The OPAAT consists of 30 items, categorized into three domains. A higher score indicates higher knowledge level. English speaking non-osteoporotic postmenopausal women 50 years of age and pharmacists were included in the study.
    Results: A total of 203 patients and 31 pharmacists were recruited. Factor analysis extracted three domains. Flesch reading ease was 59.2. The mean±SD accuracy rate was 0.60±0.22 (range: 0.26-0.94). The Cronbach’s α for each domain ranged from 0.286-0.748. All items were highly correlated (Spearman’s rho: 0.761-0.990, p<0.05), with no significant change in the overall test-retest scores, indicating that OPAAT has achieved stable reliability. Pharmacists had higher knowledge score than patients (80.9±8.7vs63.6±17.4, p<0.001), indicating
    that the OPAAT was able to discriminate between the knowledge levels of pharmacists and patients.
    Conclusion: The OPAAT was found to be a valid and reliable instrument for assessing patient’s knowledge about osteoporosis and its prevention in Malaysia. The OPAAT can be used to identify individuals in need of osteoporosis educational intervention.
    Study site:: Primary care clinic, tertiary hospital, Malaysia
  12. Toh LS, Lai PSM, Wu DB, Bell BG, Dang CPL, Low BY, et al.
    Osteoporos Sarcopenia, 2019 Sep;5(3):87-93.
    PMID: 31728426 DOI: 10.1016/j.afos.2019.09.001
    Objectives: To compare and assess the performance of 6 osteoporosis risk assessment tools for screening osteoporosis in Malaysian postmenopausal women.

    Methods: Six osteoporosis risk assessments tools (the Simple Calculated Osteoporosis Risk Estimation [SCORE], the Osteoporosis Risk Assessment Instrument, the Age Bulk One or Never Estrogen, the body weight, the Malaysian Osteoporosis Screening Tool, and the Osteoporosis Self-Assessment Tool for Asians) were used to screen postmenopausal women who had not been previously diagnosed with osteoporosis/osteopenia. These women also underwent a dual-energy X-ray absorptiometry (DXA) scan to confirm the absence or presence of osteoporosis.

    Results: A total of 164/224 participants were recruited (response rate, 73.2%), of which only 150/164 (91.5%) completed their DXA scan. Sixteen participants (10.7%) were found to have osteoporosis, whilst 65/150 (43.3%) were found to have osteopenia. Using precision-recall curves, the recall of the tools ranged from 0.50 to 1.00, whilst precision ranged from 0.04 to 0.14. The area under the curve (AUC) ranged from 0.027 to 0.161. The SCORE had the best balance between recall (1.00), precision (0.04-0.12), and AUC (0.072-0.161).

    Conclusions: We found that the SCORE had the best balance between recall, precision, and AUC among the 6 screening tools that were compared among Malaysian postmenopausal women.

  13. Saokaew S, Rayanakorn A, Wu DB, Chaiyakunapruk N
    Pharmacoeconomics, 2016 12;34(12):1211-1225.
    PMID: 27510721
    BACKGROUND: Although pneumococcal conjugate vaccines (PCVs) have been available for prevention of invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae (S. pneumoniae) for over a decade, their adoption into national immunization programmes in low- and middle-income countries (LMICs) is still limited. Economic evaluations (EEs) play a crucial role in support of evidence-informed decisions.

    OBJECTIVE: This systematic review aims to provide a critical summary of EEs of PCVs and identify key drivers of EE findings in LMICs.

    METHODS: We searched Scopus, ISI Web of Science, PubMed, Embase and Cochrane Central from their inception to 30 September 2015 and limited the search to LMICs. The search was undertaken using the search strings 'pneumococc* AND conjugat* AND (vaccin* OR immun*)' AND 'economic OR cost-effectiveness OR cost-benefit OR cost-utility OR cost-effectiveness OR cost-benefit OR cost-utility' in the abstract, title or keyword fields. To be included, each study had to be a full EE of a PCV and conducted for an LMIC. Studies were extracted and reviewed by two authors. The review involved standard extraction of the study overview or the characteristics of the study, key drivers or parameters of the EE, assumptions behind the analyses and major areas of uncertainty.

    RESULTS: Out of 134 records identified, 22 articles were included. Seven studies used a Markov model for analysis, while 15 studies used a decision-tree analytic model. Eighteen studies performed a cost-utility analysis (CUA), with disability-adjusted life-years, quality-adjusted life-years or life-years gained as a measure of health outcome, while four studies focused only on cost-effectiveness analysis (CEA). Both CEA and CUA findings were provided by eight studies. Herd effects and serotype replacement were considered in 10 and 13 studies, respectively. The current evidence shows that both the 10-valent and 13-valent PCVs are probably cost effective in comparison with the 7-valent PCV or no vaccination. The most influential parameters were vaccine efficacy and coverage (in 16 of 22 studies), vaccine price (in 13 of 22 studies), disease incidence (in 11 of 22 studies), mortality from IPD and pneumonia (in 8 of 22 studies) and herd effects (in 4 of 22 studies). The findings were found to be supportive of the products owned by the manufacturers.

    CONCLUSION: Our review demonstrated that an infant PCV programme was a cost-effective intervention in most LMICs (in 20 of 22 studies included). The results were sensitive to vaccine efficacy, price, burden of disease and sponsorship. Decision makers should consider EE findings and affordability before adoption of PCVs.

  14. Rosli MR, Wu DB, Neoh CF, Karuppannan M
    J Med Econ, 2021 5 15;24(1):730-740.
    PMID: 33989086 DOI: 10.1080/13696998.2021.1889573
    OBJECTIVE: Home medication review (HMR) programs could minimise patients' health-related costs and burdens, thereby enhancing the quality of life and well-being. The aim of this economic evaluation is to determine if home medication review by community pharmacists (HMR-CP) for patients with type 2 diabetes mellitus (T2DM) is a cost-effective intervention from the Malaysian healthcare provider perspective.

    METHODS: The economic evaluation was conducted alongside the randomised controlled trial (RCT) to estimate the intermediate cost-effectiveness of HMR-CP for patients with T2DM. A Markov model was then constructed to project the lifetime cost-effectiveness data beyond the RCT. The primary outcomes for the economic evaluation were HbA1c and quality-adjusted life-years (QALYs).

    RESULTS: The intervention and health services costs throughout the 6-month HMR-CP trial were RM121.45 (USD28.64) [95%CI: RM115.89 to 127.08 (USD27.33-29.97)] per participant. At a 6-month follow-up, a significant reduction in HbA1c of 0.902% (95% CI: 0.388% to 1.412%) was noted in the HMR-CP group compared to the control group. The ICER of HMR-CP intervention versus standard care was RM178.82 (USD 42.17) [95%CI: RM86.77-364.03 (USD20.46-85.86)] per reduction of HbA1c. HMR-CP intervention [RM12,764.82 (USD3010.57)] was associated with an incremental cost of RM83.34 (USD19.66) over control group [RM12,682.95 (USD2,991.26)] with an additional of 0.07 QALY gained. The ICER associated with HMR-CP intervention was RM1,190.57 (USD280.79) per QALY gained, which was below the ICER threshold in Malaysia, indicating that HMR-CP was a cost-effective option.

    CONCLUSION: HMR-CP was a cost-effective intervention that had significantly reduced the HbA1c among the T2DM patients, although associated with higher mean total costs per participant.

  15. Rosli MR, Neoh CF, Wu DB, Hassan NW, Mahmud M, Rahimi A, et al.
    Pharm Pract (Granada), 2021 09 09;19(3):2397.
    PMID: 34621450 DOI: 10.18549/PharmPract.2021.3.2397
    Background: Successful diabetes treatment requires commitment and understanding of disease management by the patients.

    Objective: This trial aimed to evaluate the programme effectiveness of home medication review by community pharmacists (HMR-CP) in optimising diabetes care and reducing medication wastage.

    Methods: A randomised controlled trial was conducted on 166 patients with Type 2 Diabetes Mellitus (T2DM) who were randomly assigned to the intervention or control groups. The intervention group received HMR-CP at 0-month, 3-month, and 6-month. The primary outcome was haemoglobin A1c (HbA1c) while clinical outcomes, anthropometric data, and humanistic outcomes were the secondary outcomes. For the intervention group, drug-related problems (DRP) were classified according to the Pharmaceutical Care Network Europe Foundation (PCNE). Medication adherence was determined based on the Pill Counting Adherence Ratio (PCAR). The cost of medication wastage was calculated based on the total missed dose by the T2DM patients multiplied by the cost of medication. General linear model and generalised estimating equations were used to compare data across the different time-points within and between the groups, respectively.

    Results: No significant difference was observed in the demographic and anthropometric data at baseline between the two groups except for fasting blood glucose (FBG). There was a significant reduction in the HbA1c (-0.91%) and FBG (-1.62mmol/L) over the study period (p<0.05). A similar observation was noted in diastolic blood pressure (DBP) and total cholesterol (TC) but not in high-density lipoprotein (HDL), and anthropometric parameters. Both utility value and Michigan Diabetes Knowledge Test (MDKT) scores increased significantly over time. As for the intervention group, significant changes in PCAR (p<0.001) and the number of DRP (p<0.001) were noted.

    Conclusions: HMR-CP significantly improved the glycaemic control, QoL, medication adherence, and knowledge of T2DM patients as well as reduced the number of DRP and cost of medication wastage. However, the impact of HMR-CP on certain clinical and anthropometric parameters remains inconclusive and further investigation is warranted.

  16. Rehman IU, Wu DB, Ahmed R, Khan NA, Rahman AU, Munib S, et al.
    Medicine (Baltimore), 2018 08;97(31):e10764.
    PMID: 30075491 DOI: 10.1097/MD.0000000000010764
    BACKGROUND: Pruritus adds to the complications of chronic kidney disease (CKD) patient and a well-recognized complication among the CKD patients. Majority of the patients on hemodialysis experience a generalized pruritus and patients reported being moderately to extremely disturbed by at least one of the sleep-related condition. This study aim to investigate the effectiveness of zolpidem 10 mg and acupressure therapy on foot acupoints to improve the sleep quality and overall quality of life among hemodialysis patients suffering from CKD-associated pruritus.

    METHODS: A multicentered, open-label, parallel group, prospective randomized controlled trial among patients suffering from CKD-associated pruritus with sleep disturbance, after randomization into control, and intervention group to be held at North West General Hospital and Research Center Peshawar, Pakistan and Institute of Kidney Diseases Peshawar, Pakistan.

    RESULTS: The primary outcome is to investigate the effectiveness of zolpidem 10 mg and acupressure therapy on foot acupoints to improve the sleep quality and overall quality of life among hemodialysis patients suffering from CKD-associated pruritus. After baseline assessment by Urdu version of 5D itch scale and Urdu version of Pittsburgh Sleep Quality Index (PSQI) and Urdu EQ-5D 3L, the intervention group will be given zolpidem 10 mg oral tablets and control group with acupressure on both foots on KI-1 acupoints for total of 6 minutes. Assessment will be done at weeks 4 and 8 from baseline by using Urdu version of 5D itch scale and Urdu version of PSQI and Urdu EQ-5D 3L, whereas safety profiling of zolpidem 10 mg tablet at week 6 from baseline and acupressure acceptability at week 6 from baseline. Analysis of covariance will be used to examine the differences in treatment effects between the intervention and control groups.

    CONCLUSION: Improvement of sleep quality and quality of life among patients with CKD-associated pruritus requires great importance. This study aims to improve the quality of sleep and quality of life among patients with hemodialysis suffering from CKD-associated pruritus.

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