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  1. Shiroiwa T, Murata T, Ahn J, Li X, Nakamura R, Teerawattananon Y, et al.
    Value Health Reg Issues, 2022 Nov;32:62-69.
    PMID: 36099801 DOI: 10.1016/j.vhri.2022.07.002
    OBJECTIVES: Almost all preference-based measures (PBMs) have been developed in Western countries, with none having been formulated in Asian countries. In this study, we construct a new generic PBM based on concept elicitation using interview surveys in East and Southeast Asian countries and qualitative analysis.

    METHODS: This cross-sectional study included 225 adults recruited from 9 East and Southeast Asian countries or regions (Indonesia, Japan, Korea, mainland China, Malaysia, the Philippines, Singapore, Taiwan, and Thailand). Trained interviewers conducted semistructured interviews with 25 participants from the general population of each country/region. Qualitative data were analyzed using a content analysis approach. The selection of items was determined based on interview surveys and team member discussions. The description of items was considered based on a detailed qualitative analysis of the interview survey.

    RESULTS: A new region-specific PBM-the Asia PBM 7 dimensions instrument-was designed. It reflects East and Southeast Asian values and comprises 7 items: pain, mental health, energy, mobility, work/school, interpersonal interactions, and burden to others.

    CONCLUSIONS: The new region-specific instrument is one of the first PBMs developed in the context of non-Western countries. The Asia PBM 7 dimensions contains 7 items that address the core concepts of health-related quality of life that are deemed important based on East and Southeast Asian health concepts.

    Matched MeSH terms: Quality of Life*
  2. Azmi S, Goh A, Muhammad NA, Tohid H, Rashid MRA
    Value Health Reg Issues, 2018 May;15:42-49.
    PMID: 29474177 DOI: 10.1016/j.vhri.2017.06.002
    BACKGROUND: Anemia is common among patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) and an independent risk factor for renal disease progression. Health economic evidence is important in Malaysia and yet cost and quality-of-life (QOL) data are scarce.

    OBJECTIVES: To investigate prevalence, factors associated with anemia, and cost and QOL among T2DM patients with CKD. Here, we present the estimated 1-year cost and QOL related to anemia in this group.

    METHODS: A cross-sectional, observational study was performed at 20 government clinics. Treatment cost was calculated on the basis of resource utilization ascertained through data extracted from medical records and patient recall. QOL was elicited using the short form 36 health survey version 2 questionnaire. Propensity score matching was performed and costs and QOL were analyzed by anemia status and CKD stage.

    RESULTS: Data for 816 patients were obtained. The propensity score matching enabled a comparison of 257 patients with and without anemia. Annual treatment costs were significantly higher for patients with anemia (Ringgit Malaysia [RM] 4219 [US $983] vs. RM2705 [US $630]; P = 0.01). QOL scores were lower for patients with anemia but not statistically significant (physical component summary score: 44.8 vs. 46.2; P = 0.052; mental component summary score: 51.3 vs. 51.7; P = 0.562). Costs were higher and QOL lower among CKD stage 5 patients.

    CONCLUSIONS: This study was the first to examine anemia in this group of patients. Costs were significantly higher among anemic patients compared with nonanemic patients; patients with higher CKD stage 5 fared less well than did those in lower stages. This information suggests the need to increase detection, prevention, and early treatment of anemia when managing T2DM patients, particularly those with CKD.
    Matched MeSH terms: Quality of Life/psychology*
  3. Yusof FA, Goh A, Azmi S
    Value Health, 2012 Jan-Feb;15(1 Suppl):S85-90.
    PMID: 22265073 DOI: 10.1016/j.jval.2011.11.024
    OBJECTIVES: To estimate a EQ-5D value set for Malaysia by using time trade-off (TTO) and visual analogue scale (VAS) valuation methods.
    METHODS: TTO and VAS valuations were obtained from face-to-face surveys of a convenience sample of patients, caregivers, and health professionals conducted at nine government hospitals in 2004 and 2005. Forty-five EQ-5D questionnaire health states were valued, divided into five sets of 15 health states. Analysis was conducted by using linear additive regression models applying N3 and D1 specifications. Model selection was based on criteria of coefficient properties, statistical significance, and goodness of fit.
    RESULTS: One hundred fifty-two respondents were interviewed, yielding 2174 TTO and 2265 VAS valuations. Respondents found TTO valuations to be more difficult than VAS valuations, and there were more inconsistencies in TTO valuations. All the independent variables in the models were statistically significant and consistent with expected signs and magnitude, except for the D1 specification modeled on TTO valuations. The N3 model provided the best fit for the VAS valuation data, with a mean absolute error of 0.032.
    CONCLUSION: This study provides a Malaysian EQ-5D questionnaire value set that can be used for cost-utility studies despite survey limitations.
    Study site: convenience sampling from three categories of respondents (patients undergoing dialysis, patients’ carers, and dialysis center staff) from public hospitals
    Matched MeSH terms: Quality of Life/psychology*
  4. Wee HL, Li SC, Xie F, Zhang XH, Luo N, Feeny D, et al.
    Value Health, 2008 Mar;11 Suppl 1:S3-10.
    PMID: 18387064 DOI: 10.1111/j.1524-4733.2008.00361.x
    OBJECTIVES: To assess the validity, feasibility and acceptability of standard gamble (SG) and time trade-off (TTO) assessments in a multiethnic Asian population.
    METHODS: Through in-depth interviews performed among Chinese, Malay, and Indian Singaporeans (education >or= 6 years), we assessed validity of SG/TTO methods for eliciting health preferences by hypothesizing that 1) SG/TTO scores for three hypothetical health states (HS) would exhibit ranked order (decreasing scores with worse HS); and 2) more subjects would rate the most severe HS as worse than dead. Subjects also evaluated feasibility and acceptability of SG/TTO using a 10-point visual analog scale (VAS) and open-ended questions. Ratings were compared using Kruskal-Wallis, Wilcoxon signed-rank tests or tests of proportions.
    RESULTS: VALIDITY: In 62 subjects (90% response rate), as hypothesized, SG and TTO scores exhibited ranked order with increasing HS severity (SG: 0.85, 0.08, -19.00; TTO: 0.85, 0.00, -0.18). More subjects rated the most severe HS as worse than dead (SG: 8%, 39%, 59%; TTO: 8%, 45% and 62%).
    FEASIBILITY: Subjects felt SG and TTO were easy to understand (median VAS scores: 8.0 vs. 8.0, P = 0.87) and to complete (8.0 vs. 8.0, P = 0.84). Acceptability: SG and TTO were well accepted, with TTO less so than SG (median [interquartile range] offensiveness: 2.0 [0, 4.0] vs. 2.0 [0, 3.0], P = 0.045). Overall, subjects did not have a clear preference for SG/TTO (50% vs. 45%, P = 0.70).
    CONCLUSIONS: This study suggests the validity, feasibility and acceptability of SG and TTO for population-based HS valuation studies in a multiethnic Asian population.
    Matched MeSH terms: Quality of Life*
  5. Wee HL, Cheung YB, Loke WC, Tan CB, Chow MH, Li SC, et al.
    Value Health, 2008 Mar;11 Suppl 1:S105-14.
    PMID: 18387053 DOI: 10.1111/j.1524-4733.2008.00374.x
    To evaluate the association between body mass index (BMI) and health-related quality of life (HRQoL) in a multiethnic Asian population in Singapore, and to explore if the World Health Organization (WHO) recommendation of alternative BMI cutoffs for Asians could be further strengthened by evidence of higher risk of impaired HRQoL using these criteria.
    Matched MeSH terms: Quality of Life*
  6. Kongpakwattana K, Dejthevaporn C, Krairit O, Dilokthornsakul P, Mohan D, Chaiyakunapruk N
    Value Health, 2019 10;22(10):1137-1145.
    PMID: 31563256 DOI: 10.1016/j.jval.2019.04.1937
    BACKGROUND: Although an increase in the burden of Alzheimer's disease (AD) is evident worldwide, knowledge of costs and health-related quality of life (HRQOL) associated with AD in low- and middle-income countries is still lacking.

    OBJECTIVES: This study aimed to collect real-world cost and HRQOL data, and investigate their associations with multiple disease-severity indicators among AD patients in Thailand.

    METHODS: We recruited AD patients aged ≥60 years accompanied by their caregivers at a university-affiliated tertiary hospital. A one-time structured interview was conducted to collect disease-severity indicators, HRQOL, and caregiving information using standardized tools. The hospital's database was used to retrieve healthcare resource utilization occurred over 6 months preceding the interview date. Costs were annualized and stratified based on cognitive status. Generalized linear models were employed to evaluate determinants of costs and HRQOL.

    RESULTS: Among 148 community-dwelling patients, average annual total societal costs of AD care were $8014 (95% confidence interval [CI]: $7295-$8844) per patient. Total costs of patients with severe stage ($9860; 95% CI: $8785-$11 328) were almost twice as high as those of mild stage ($5524; 95% CI: $4649-$6593). The major cost driver was direct medical costs, particularly those incurred by AD prescriptions. Functional status was the strongest determinant for both total costs and patient's HRQOL (P value

    Matched MeSH terms: Quality of Life*
  7. Henry EB, Barry LE, Hobbins AP, McClure NS, O'Neill C
    Value Health, 2020 07;23(7):936-944.
    PMID: 32762996 DOI: 10.1016/j.jval.2020.03.003
    OBJECTIVES: To estimate and compare the minimally important difference (MID) in index score of country-specific EQ-5D-5L scoring algorithms developed using EuroQol Valuation Technology protocol version 2, including algorithms from Germany, Indonesia, Ireland, Malaysia, Poland, Portugal, Taiwan, and the United States.

    METHODS: A simulation-based approach contingent on all single-level transitions defined by the EQ-5D-5L descriptive system was used to estimate the MID for each algorithm.

    RESULTS: The resulting mean (and standard deviation) instrument-defined MID estimates were Germany, 0.083 (0.022); Indonesia, 0.093 (0.012); Ireland, 0.098 (0.023); Malaysia, 0.072 (0.010); Poland, 0.080 (0.030); Portugal, 0.080 (0.018); Taiwan, 0.101 (0.010); and the United States, 0.078 (0.014).

    CONCLUSIONS: These population preference-based MID estimates and accompanying evidence of how such values vary as a function of baseline index score can be used to aid interpretation of index score change. The marked consistency in the relationship between the calculated MID estimate and the range of the EQ-5D-5L index score, represented by a ratio of 1:20, might substantiate a rule of thumb allowing for MID approximation in EQ-5D-5L index score warranting further investigation.

    Matched MeSH terms: Quality of Life*
  8. Lim YW, Shafie AA, Chua GN, Ahmad Hassali MA
    Value Health, 2017 09;20(8):1131-1138.
    PMID: 28964445 DOI: 10.1016/j.jval.2017.04.002
    BACKGROUND: One major challenge in prioritizing health care using cost-effectiveness (CE) information is when alternatives are more expensive but more effective than existing technology. In such a situation, an external criterion in the form of a CE threshold that reflects the willingness to pay (WTP) per quality-adjusted life-year is necessary.

    OBJECTIVES: To determine a CE threshold for health care interventions in Malaysia.

    METHODS: A cross-sectional, contingent valuation study was conducted using a stratified multistage cluster random sampling technique in four states in Malaysia. One thousand thirteen respondents were interviewed in person for their socioeconomic background, quality of life, and WTP for a hypothetical scenario.

    RESULTS: The CE thresholds established using the nonparametric Turnbull method ranged from MYR12,810 to MYR22,840 (~US $4,000-US $7,000), whereas those estimated with the parametric interval regression model were between MYR19,929 and MYR28,470 (~US $6,200-US $8,900). Key factors that affected the CE thresholds were education level, estimated monthly household income, and the description of health state scenarios.

    CONCLUSIONS: These findings suggest that there is no single WTP value for a quality-adjusted life-year. The CE threshold estimated for Malaysia was found to be lower than the threshold value recommended by the World Health Organization.

    Matched MeSH terms: Quality of Life*
  9. Yong ASJ, Lim KK, Fox-Rushby J, Ismail F, Hamzah E, Cheong MWL, et al.
    Value Health, 2023 Dec;26(12):1772-1781.
    PMID: 37741445 DOI: 10.1016/j.jval.2023.08.009
    OBJECTIVES: This study aims to quantify the preferences of patients with advanced cancer for quality of life (QoL) outcomes versus survival extension in Malaysia. The secondary aim of this study is to explore the change in preferences over time.

    METHODS: A discrete choice experiment was developed to include 7 attributes valued in cancer management: physical, psychological and social functioning, pain control, survival, place of death, and cost. Patients were recruited via convenience sampling from 2 Malaysian public hospitals. The survey questionnaire was administered to patients within 6 months of their cancer diagnosis with a follow-up 3 months later. Conditional logit regression was used to estimate the preference weight, relative attribute importance, and willingness to pay.

    RESULTS: One hundred valid responses were collected at baseline and 45 at follow-up. Respondents placed higher values on QoL improvements from severe to moderate or mild levels and to achieve home death over survival extension from 6 to 18 months. However, additional improvements (from moderate to mild) in some of the QoL outcomes were not valued as highly as life extension from 12 to 18 months, showing that it was vital for patients to avoid being in "severe" health dysfunction. Improving physical dysfunction from severe to mild yielded 3 times as much value as additional 1-year survival. After 3 months, the respondents' preferences changed significantly, with increased relative attribute importance of physical functioning, pain control, and cost.

    CONCLUSIONS: As QoL outcomes are valued more than survival, palliative care should be introduced as early as possible to alleviate suffering related to advanced cancer.

    Matched MeSH terms: Quality of Life*
  10. Low BY, Liong ML, Yuen KH, Chong WL, Chee C, Leong WS, et al.
    Urology, 2006 Oct;68(4):751-8.
    PMID: 17070347
    To determine the prevalence, severity, and quality-of-life (QOL) impact of female lower urinary tract symptoms (FLUTS); to determine the patterns, reasons, and factors contributing to the women's treatment-seeking behavior; and to describe the relationship between the social demographic characteristics and FLUTS.
    Matched MeSH terms: Quality of Life
  11. Cheah PY, Liong ML, Yuen KH, Teh CL, Khor T, Yang JR, et al.
    Urology, 2004 Nov;64(5):881-6.
    PMID: 15533470 DOI: 10.1016/j.urology.2004.06.041
    OBJECTIVES: To evaluate the initial, long-term, and durable response rates to terazosin, placebo, or other therapies in patients with chronic prostatitis/chronic pelvic pain syndrome.
    METHODS: A total of 100 subjects, aged 20 to 50 years, who met the National Institutes of Health criteria for chronic prostatitis/chronic pelvic pain syndrome and had not previously been treated with alpha-blockers, were entered in a 14-week, double-blind comparison of terazosin or placebo therapy. Nonresponders and responders with subsequent relapse were treated with terazosin or other medications (open label). The criterion for response was a score of 0 to 2 on the National Institutes of Health Chronic Prostatitis Symptom Index quality-of-life item. The initial response was evaluated at week 14, and the long-term response was evaluated after a median of 38 weeks (range 34 to 42), regardless of any additional treatment. A durable response was defined as an initial response without additional treatment.
    RESULTS: Of the 43 patients in the terazosin group, 24 (56%) had an initial response compared with 14 (33%) of 43 subjects in the placebo group (P = 0.03). Long-term responses were noted in 23 (56%) of 41 assessable subjects treated with terazosin initially compared with 12 (32%) of 38 assessable subjects treated with placebo (P = 0.03). Of the nonresponders and initial responders with relapse, 7 (41%) of 17 subjects responded to terazosin compared with 7 (21%) of 34 given other treatment (P = 0.12). Durable responses occurred in 18 (44%) of the 41 assessable patients treated initially with terazosin and in 6 (16%) of 38 treated initially with placebo (P = 0.01).
    CONCLUSIONS: Patients treated with terazosin were more likely to have initial, long-term, and durable responses than those treated with placebo.
    Matched MeSH terms: Quality of Life
  12. Lim R, Liong ML, Lim KK, Leong WS, Yuen KH
    Urology, 2019 Nov;133:91-95.
    PMID: 31415780 DOI: 10.1016/j.urology.2019.08.004
    OBJECTIVE: To estimate the minimum clinically important difference (MCID) of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) using both anchor-based and distribution-based methods for women with stress urinary incontinence undergoing nonsurgical treatment.

    MATERIALS AND METHODS: Data from a randomized clinical trial evaluating efficacy of a nonsurgical intervention in women with stress urinary incontinence were used for analyses. The overall score of ICIQ-UI SF ranges from 0 to 21, with greater values indicating increased severity. The ICIQ-LUTSqol ranges from 19 to 76, with greater values indicating increased impact on quality of life. Instruments used in the anchor-based method were the Patient Global Impression of Improvement, patient satisfaction, 1-hour pad test and the incontinence episode frequency. The distribution-based method used an effect size of 0.5 standard deviation. Triangulation of findings was used to converge on a single value of MCID.

    RESULTS: At 12-month post-treatment, 106 (88.3%) participants completed the follow-up and were included in the analysis. Anchor-based MCIDs of the ICIQ-UI SF were between 3.4 and 4.4, while the distribution-based MCID was 1.7. Anchor-based MCIDs of the ICIQ-LUTSqol were between 4.8 and 6.9, while the distribution-based MCID was 5.2. Triangulation of findings showed that MCIDs of 4 for ICIQ-UI SF and 6 for ICIQ-LUTSqol were the most appropriate.

    CONCLUSION: For women undergoing nonsurgical treatments for incontinence, reductions of 4 and 6 points in ICIQ-UI SF and ICIQ-LUTSqol, respectively are perceived as clinically meaningful.

    Matched MeSH terms: Quality of Life*
  13. Lim R, Liong ML, Leong WS, Lau YK, Khan NAK, Yuen KH
    Urology, 2018 Feb;112:38-45.
    PMID: 29107131 DOI: 10.1016/j.urology.2017.10.019
    OBJECTIVE: To assess the impact of stress urinary incontinence (SUI) on individual components of quality of life (QoL) using both condition-specific and generic questionnaires, and to compare the results of the 2 instruments with a control group.

    METHODS: Women with or without SUI aged ≥21 years old were recruited. Subjects completed the International Consultation of Incontinence-Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation of Incontinence-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), and EQ-5D questionnaires.

    RESULTS: A total of 120 women with SUI and 145 controls participated. The ICIQ-LUTSqol total score (mean ± standard deviation) was significantly higher in the SUI group (38.96 ± 10.28) compared with the control group (20.78 ± 2.73) (P 

    Matched MeSH terms: Quality of Life*
  14. Clemente N, Yagnik VD, James KCW
    Updates Surg, 2024 Apr;76(2):723-724.
    PMID: 38150156 DOI: 10.1007/s13304-023-01742-x
    Matched MeSH terms: Quality of Life
  15. Khadijah Alavi, Noraini Che’ Sharif, Ponnusamy Subramaniam, Ponnusamy Subramaniam
    MyJurnal
    Kajian ini bertujuan mengenal pasti hubungan antara kebimbangan dan kemurungan dengan kualiti hidup warga emas demensia di institusi jagaan warga emas. Kajian ini turut mencadangkan terapi kelompok reminiscence dalam menurunkan kebimbangan dan kemurungan dalam kalangan penghuni di institusi. Reka bentuk kajian yang digunakan ialah kajian keratan rentas dan telah dijalankan di Rumah Sri Kenangan Cheras. Seramai 58 warga emas demensia tahap ringan dan sederhana dipilih melalui proses penyaringan oleh pakar psikologi klinikal. Kajian kuantitatif ini telah menggunakan instrumen Quality of Life-AD (QoL-AD), Geriatric Depression Scale (GDS)) dan Beck Anxiety Inventory (BAI) untuk mengkaji hubungan antara kebimbangan dan kemurungan dengan kualiti hidup warga emas demensia. Hasil kajian menunjukkan terdapat hubungan yang tidak signifikan antara kualiti hidup dengan tahap kebimbangan. Manakala hubungan antara kualiti hidup dan tahap kemurungan warga emas demensia di RSK Cheras adalah signifikan. Pengaplikasian terapi kelompok reminiscence sebagai salah satu intervensi yang berkesan dalam membantu meningkatkan kualiti hidup dan menurunkan kebimbangan dan kemurungan dalam kalangan warga emas di institusi penjagaan telah dibincangkan.
    Matched MeSH terms: Quality of Life
  16. Salman M, Khan AH, Sulaiman SAS, Hughes J, Khan JH, Hussain K
    Turk J Urol, 2018 Jul;44(4):335-340.
    PMID: 29932403 DOI: 10.5152/tud.2018.44834
    OBJECTIVE: The objective of the current study was to develop an Urdu version of the International Prostate Symptom Score (IPSS-U) and validate it for Pakistani patients suffering from lower urinary tract symptoms (LUTS).
    MATERIAL AND METHODS: IPSS-U was developed by a two-step forward and back translation and to evaluate its psychometric properties, a prospective study involving patients suffering from LUTS (n=267) was conducted at Outpatient Urology Department, Mayo Hospital, Lahore, Pakistan. Internal consistency and reproducibility were assessed using Cronbach's alpha and the Intra-Class Correlation Coefficient (ICC). Moreover, exploratory, and confirmatory factor analyses were performed to determine dimensionality of IPSS-U items.
    RESULTS: Overall reliability of IPSS-U was satisfactory (Cronbach's alpha=0.72, ICC of symptom questions=0.92 and ICC of QOL index=0.75). Exploratory factor analysis revealed that two factors were consistent, which together explained 59.8% of the variance. IPSS-U items 1, 3, 5 and 6 were components of the first factor whereas item 2, 4 and 7 were components of the second factor. All the items loaded high on their factors and there were no cross loadings. Moreover, confirmatory factor analysis also showed two-factor model, with acceptable fitting patterns.
    CONCLUSION: IPSS-U is a valid and reliable non-gender specific instrument to assess the frequency and severity of LUTS in Urdu-speaking population.
    Matched MeSH terms: Quality of Life
  17. Duruöz MT, Şanal Toprak C, Ulutatar F, Suhaimi A, Agirbasli M
    Turk Kardiyol Dern Ars, 2020 Nov;48(8):731-738.
    PMID: 33257610 DOI: 10.5543/tkda.2020.24583
    OBJECTIVE: The purpose of this study was to assess the validity and reliability of a Turkish version of the Seattle Angina Questionnaire (SAQ) in patients with coronary heart disease (CHD) and angina.

    METHODS: The SAQ was translated from English to Turkish using the back-translation method. It contains 19 questions scored from 1 to either 5 or 6 in 5 domains (physical limitation, angina stability, angina frequency, disease perception, and treatment satisfaction). Cronbach's alpha coefficient was used to evaluate internal consistency. Spearman's rank correlation coefficient was calculated to assess the construct validity. Convergent validity was examined using correlations between the SAQ and the MacNew Heart Disease Health-related Quality of Life Questionnaire (MacNew) and the Nottingham Health Profile. Divergent validity was evaluated using correlations between the SAQ and age, body mass index (BMI), gender, and the marital status of patients. A value of p<0.05 was considered statistically significant.

    RESULTS: Sixty-seven patients were enrolled in the study. The mean age of the study patients was 58.7 years (SD: 10.2). Cronbach's alpha scores of the SAQ, ranging in value from 0.715 to 0.910, demonstrated that this scale is reliable. All of the SAQ scales had a significant correlation with all of the MacNew scales, which indicated that the scale has convergent validity. Insignificant correlations with age, BMI, gender, and marital status illustrated the good divergent validity of the scale.

    CONCLUSION: The Turkish version of the SAQ is a valid and reliable instrument. It is a useful and practical tool to evaluate patients with angina and CHD.

    Matched MeSH terms: Quality of Life
  18. Lim R, Liong ML, Leong WS, Khan NA, Yuen KH
    Trials, 2015;16:279.
    PMID: 26093910 DOI: 10.1186/s13063-015-0803-1
    There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence.
    Matched MeSH terms: Quality of Life
  19. Naqvi AA, Hassali MA, Naqvi SBS, Aftab MT
    Trials, 2019 Aug 09;20(1):488.
    PMID: 31399128 DOI: 10.1186/s13063-019-3540-z
    BACKGROUND: The objective of this study is to evaluate the effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health-related quality of life (HRQoL) and direct cost of treatment. The study also documents patient satisfaction with pharmacist counselling as a quality control measure.

    METHODS/DESIGN: This is a randomized, single-blind, two-arm, controlled trial in patients with rheumatoid arthritis visiting outpatient rheumatology clinics in Karachi, Pakistan. We will enroll patients with established diagnosis of rheumatoid arthritis over 3 months. The patients would be randomized through a computer-generated list into the control group, i.e., usual care or into the intervention group, i.e., pharmaceutical care, in a ratio of 1:1, after providing signed written consent. The study will take place in two patient-visits over the course of 3 months. Patients in the intervention group would receive intervention from the pharmacist while those in the control group will receive usual care. Primary outcomes include change in mean score from baseline (week 0) and at follow up (week 12) in disease knowledge, adherence to medications and rehabilitation/physical therapy. The secondary outcomes include change in the mean direct cost of treatment, HRQoL and patient satisfaction with pharmacist counselling.

    DISCUSSION: This is a novel study that evaluates the role of the pharmacist in improving treatment outcomes in patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for this patient population in Pakistan. The results of this trial would be published in a peer-reviewed journal.

    TRIAL REGISTRATION: ClinicalTrials.gov, NCT03827148 . Registered on February 2019.

    Matched MeSH terms: Quality of Life
  20. Katijjahbe MA, Denehy L, Granger CL, Royse A, Royse C, Bates R, et al.
    Trials, 2017 06 23;18(1):290.
    PMID: 28645301 DOI: 10.1186/s13063-017-1974-8
    BACKGROUND: The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery.

    METHODS/DESIGN: This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported.

    DISCUSSION: The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy.

    TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).

    Matched MeSH terms: Quality of Life
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