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  1. Zanudin A, Mercer TH, Jagadamma KC, van der Linden ML
    Gait Posture, 2017 10;58:30-40.
    PMID: 28711651 DOI: 10.1016/j.gaitpost.2017.07.005
    Availability of outcome measures (OMs) with robust psychometric properties is an essential prerequisite for the evaluation of interventions designed to address gait deterioration in young people with Cerebral Palsy (CP). This review evaluates evidence for the reliability, validity and responsiveness of outcome measures of gait quality and walking performance in young people with CP. A systematic search was performed in MEDLINE, CINAHL, PubMed and Scopus. Articles that met the eligibility criteria were selected. Methodological quality of studies was independently rated by two raters using the modified COnsensus-based Standard for the selection of health status Measurement INstruments checklist. Strength of evidence was rated using standardised guidelines. Best evidence synthesis was scored according to Cochrane criteria. Fifty-one articles reporting on 18 distinct OMs were included for review. Best evidence synthesis indicated a moderate to strong evidence for the reliability for OMs of walking performance but conflicting evidence for the reliability of OMs of gait quality. The evidence for responsiveness for all OMs included in this review was rated as 'unknown'. The limitations of using the modified COSMIN scoring for small sample sizes are acknowledged. Future studies of high methodological quality are needed to explore the responsiveness of OMs assessing gait quality and walking performance in young people with CP.
  2. Zack R, Okunade O, Olson E, Salt M, Amodeo C, Anchala R, et al.
    Hypertension, 2019 05;73(5):990-997.
    PMID: 30929516 DOI: 10.1161/HYPERTENSIONAHA.118.11916
    High blood pressure is the leading modifiable risk factor for mortality, accounting for nearly 1 in 5 deaths worldwide and 1 in 11 in low-income countries. Hypertension control remains a challenge, especially in low-resource settings. One approach to improvement is the prioritization of patient-centered care. However, consensus on the outcomes that matter most to patients is lacking. We aimed to define a standard set of patient-centered outcomes for evaluating hypertension management in low- and middle-income countries. The International Consortium for Health Outcomes Measurement convened a Working Group of 18 experts and patients representing 15 countries. We used a modified Delphi process to reach consensus on a set of outcomes, case-mix variables, and a timeline to guide data collection. Literature reviews, patient interviews, a patient validation survey, and an open review by hypertension experts informed the set. The set contains 18 clinical and patient-reported outcomes that reflect patient priorities and evidence-based hypertension management and case-mix variables to allow comparisons between providers. The domains included are hypertension control, cardiovascular complications, health-related quality of life, financial burden of care, medication burden, satisfaction with care, health literacy, and health behaviors. We present a core list of outcomes for evaluating hypertension care. They account for the unique challenges healthcare providers and patients face in low- and middle-income countries, yet are relevant to all settings. We believe that it is a vital step toward international benchmarking in hypertension care and, ultimately, value-based hypertension management.
  3. Yik YI, Stathopoulos L, Hutson JM, Southwell BR
    Neuromodulation, 2016 Jul;19(5):515-21.
    PMID: 27293084 DOI: 10.1111/ner.12451
    AIM: As transcutaneous electrical stimulation (TES) increased defecation in children and adults with Slow-Transit Constipation (STC), we performed a pilot study to test if TES can improve symptoms (defecation and soiling) in children with chronic constipation without STC and transit delay in the anorectum.

    METHODS: Children with treatment-resistant constipation presenting to a tertiary hospital had gastrointestinal nuclear transit study (NTS) showing normal proximal colonic transit and anorectal holdup of tracer. TES was administered at home (1 hour/day for 3 months) using a battery-powered interferential stimulator, with four adhesive electrodes (4 × 4 cm) connected so currents cross within the lower abdomen at the level of S2-S4. Stimulation was added to existing laxatives. Daily continence diary, and quality-of-life questionnaires (PedsQL4.0) were compared before and after TES.

    RESULTS: Ten children (4 females: 5-10 years, mean 8 years) had holdup in the anorectum by NTS. Nine had <3 bowel motions (BM)/week. After three months TES, defecation frequency increased in 9/10 (mean 0.9-4.1 BM/week, p = 0.004), with 6/9 improved to ≥3 BM/week. Soiling reduced in 9/10 from 5.9 to 1.9 days/week with soiling, p = 0.004. Ten were on laxatives, and nine reduced/stopped laxative use. Quality-of-life improved to within the normal range.

    CONCLUSION: TES improved symptoms of constipation in >50% of children with treatment-resistant constipation with isolated holdup in the anorectum. Further studies (RCTs) are warranted in these children.

  4. Yii MK
    Asian J Surg, 2003 Jul;26(3):149-53.
    PMID: 12925289 DOI: 10.1016/S1015-9584(09)60374-2
    Abdominal aortic aneurysm (AAA) repairs represent a significant workload in vascular surgery in Asia. This study aimed to audit AAA surgery and evaluate the application of the Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) in an Asian vascular unit for standard of care. Eighty-five consecutive surgical patients with AAA from a prospective vascular database from July 1996 to December 2001 in Sarawak were available for analysis. Comparisons between predicted deaths by P-POSSUM and observed deaths in both urgency of surgery categories (elective, urgent, emergency ruptures) and risk range groups (0-5%, >5-15%, >15-50%, >50-100%) were made. No significant difference was found between the predicted and observed rates of death for elective, urgent and emergency AAA repairs. The observed mortality rates were 5%, 18% and 30%, respectively. The observed rates of death were also comparable to P-POSSUM predicted rates of death in the various risk range groups. The POSSUM score used with the P-POSSUM mortality equation is easy to use and applicable as a comparative vascular auditing tool in Asia.
  5. Yew BS, Ong WC, Chow WC, Lui HF
    Med J Malaysia, 2007 Aug;62(3):201-5.
    PMID: 18246907
    This retrospective study evaluated patients admitted to the Department of Gastroenterology, Singapore General Hospital for variceal bleeding in the year 2004. Improvement in outcome of variceal bleeding has been reported in the West. There is no regional data on this condition. This study aims to determine the characteristics and outcome of variceal bleeding in a tertiary hospital in Southeast Asia. Twenty-two patients were eligible. The main aetiologies of liver cirrhosis were chronic hepatitis B (38%) and alcohol (33%). Child's A, B and C were 29%, 48% and 24% respectively. Nineteen patients (86%) had bleeding oesophageal varices (band ligation performed). The remaining three patients (14%) had bleeding gastric varices (N-butyl-2-cyanoacrylate injection performed). Detailed description of certain endoscopic findings was absent in up to 18 patients (82%). All patients received antibiotics and vasoactive drug. In-hospital mortality and rebleeding were 9% and 18% respectively. We conclude that the relatively low in-hospital mortality and rebleeding rates in our series are most probably due to the smaller proportion of patients with severe liver dysfunction and management which adhered to recommendations. Documentation of endoscopic findings needs to be improved to facilitate the continuation of care.
    Matched MeSH terms: Outcome Assessment (Health Care)*
  6. Ye Q, Zou B, Yeo YH, Li J, Huang DQ, Wu Y, et al.
    Lancet Gastroenterol Hepatol, 2020 08;5(8):739-752.
    PMID: 32413340 DOI: 10.1016/S2468-1253(20)30077-7
    BACKGROUND: Although non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, it is increasingly being identified in non-obese individuals. We aimed to characterise the prevalence, incidence, and long-term outcomes of non-obese or lean NAFLD at a global level.

    METHODS: For this systematic review and meta-analysis, we searched PubMed, Embase, Scopus, and the Cochrane Library from inception to May 1, 2019, for relevant original research articles without any language restrictions. The literature search and data extraction were done independently by two investigators. Primary outcomes were the prevalence of non-obese or lean people within the NAFLD group and the prevalence of non-obese or lean NAFLD in the general, non-obese, and lean populations; the incidence of NAFLD among non-obese and lean populations; and long-term outcomes of non-obese people with NAFLD. We also aimed to characterise the demographic, clinical, and histological characteristics of individuals with non-obese NAFLD.

    FINDINGS: We identified 93 studies (n=10 576 383) from 24 countries or areas: 84 studies (n=10 530 308) were used for the prevalence analysis, five (n=9121) were used for the incidence analysis, and eight (n=36 954) were used for the outcomes analysis. Within the NAFLD population, 19·2% (95% CI 15·9-23·0) of people were lean and 40·8% (36·6-45·1) were non-obese. The prevalence of non-obese NAFLD in the general population varied from 25% or lower in some countries (eg, Malaysia and Pakistan) to higher than 50% in others (eg, Austria, Mexico, and Sweden). In the general population (comprising individuals with and without NAFLD), 12·1% (95% CI 9·3-15·6) of people had non-obese NAFLD and 5·1% (3·7-7·0) had lean NAFLD. The incidence of NAFLD in the non-obese population (without NAFLD at baseline) was 24·6 (95% CI 13·4-39·2) per 1000 person-years. Among people with non-obese or lean NALFD, 39·0% (95% CI 24·1-56·3) had non-alcoholic steatohepatitis, 29·2% (21·9-37·9) had significant fibrosis (stage ≥2), and 3·2% (1·5-5·7) had cirrhosis. Among the non-obese or lean NAFLD population, the incidence of all-cause mortality was 12·1 (95% CI 0·5-38·8) per 1000 person-years, that for liver-related mortality was 4·1 (1·9-7·1) per 1000 person-years, cardiovascular-related mortality was 4·0 (0·1-14·9) per 1000 person-years, new-onset diabetes was 12·6 (8·0-18·3) per 1000 person-years, new-onset cardiovascular disease was 18·7 (9·2-31·2) per 1000 person-years, and new-onset hypertension was 56·1 (38·5-77·0) per 1000 person-years. Most analyses were characterised by high heterogeneity.

    INTERPRETATION: Overall, around 40% of the global NAFLD population was classified as non-obese and almost a fifth was lean. Both non-obese and lean groups had substantial long-term liver and non-liver comorbidities. These findings suggest that obesity should not be the sole criterion for NAFLD screening. Moreover, clinical trials of treatments for NAFLD should include participants across all body-mass index ranges.

    FUNDING: None.

  7. Yakob M, Hassan YR, Tse KL, Gu M, Yang Y
    PMID: 28092164 DOI: 10.1597/16-191
    Objective To test the reliability of the modified Huddart-Bodenham (MHB) numerical scoring system and its agreement with the GOSLON Yardstick categorization for assessing the dental arch relationships in unilateral cleft lip and palate (UCLP) cases. Design A retrospective study. Setting Faculty of Dentistry, The University of Hong Kong. Patients Forty-one nonsyndromic UCLP consecutive patients attending the Joint Cleft Lip/Palate Clinic at Faculty of Dentistry in the University of Hong Kong were selected. Interventions Study models at 8 to 10 years old (T1) and 10 to 12 years old (T2) were obtained from each patient. Main Outcome Measures Models were rated with the MHB scoring system and GOSLON Yardstick index. The intra- and interexaminer reliabilities as well as correlation of both scoring systems were evaluated. Furthermore, to investigate the outcome measurements consistency, the MHB scoring system and GOSLON Yardstick were independently used to compare the dental arch relationships from T1 to T2, with the samples split into intervention and nonintervention groups. Results The MHB scoring system presented good intra- and interexaminer agreement, which were comparable to those of the GOSLON Yardstick. The correlation between the MHB scoring system and GOSLON Yardstick scores was good. Both scoring systems showed similar results when assessing the change in the dental arch relationships from T1 to T2. Conclusions The MHB scoring system can be used as an alternative method to the commonly used GOSLON Yardstick for assessing dental deformities in UCLP patients. Both scoring systems showed similar results in assessing the improvement in dental arch relationships.
  8. 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.
  9. Wariki WM, Mori R, Boo NY, Cheah IG, Fujimura M, Lee J, et al.
    J Paediatr Child Health, 2013 Jan;49(1):E23-7.
    PMID: 23282105 DOI: 10.1111/jpc.12054
    The study aims to determine the risk factors associated with mortality and necrotising enterocolitis (NEC) among very low birthweight infants in 95 neonatal intensive care units in the Asian Network on Maternal and Newborn Health.
  10. Wan Mohd Yunus WMA, Musiat P, Brown JS
    JMIR Ment Health, 2019 Apr 26;6(4):e11401.
    PMID: 31025943 DOI: 10.2196/11401
    BACKGROUND: Depression in the workplace is a very common problem that exacerbates employees' functioning and consequently influences the productivity of organizations. Despite the commonness of the problem and the currently available interventions, a high proportion of employees do not seek help. A new intervention, a webinar (Web-based seminar), was developed, which integrated the use of technology and the traditional guided therapist support to provide accessible help for the problem of depression in the workplace.

    OBJECTIVE: The aim of this study was to explore the feasibility, preliminary outcome, and acceptability of the webinar intervention conducted in organizations.

    METHODS: In total, 2 organizations were invited to participate, and 33 employees participated in this proof-of-concept study. The webinar intervention consisted of 6 1-hour sessions conducted via the Adobe Connect platform, developed by Adobe Inc. The intervention was developed based on a systematic review, focus group studies, and face-to-face self-confidence workshops that utilized cognitive behavior therapy (CBT). The final webinar intervention used CBT and the coping flexibility approach. The structure of the intervention included PowerPoint presentations, animation videos, utilization of chat panels, and whiteboard features. The intervention was conducted live and guided by a consultant psychologist assisted by a moderator. Study outcomes were self-assessed using self-reported Web surveys. The acceptability of the intervention was assessed using self-reported user experience Web surveys and open-ended questions.

    RESULTS: The findings showed: (1) evidence of feasibility of the intervention: the webinar intervention was successfully conducted in 3 groups, with 6 1-hour sessions for each group, with 82% (23/28) participants completing all 6 sessions; (2) positive improvements in depression: the linear mixed effects modeling analysis recorded a significant overall effect of time primarily for depression (F2, 48.813=31.524; P

  11. Wan Kasim SH, Midin M, Abu Bakar AK, Sidi H, Nik Jaafar NR, Das S
    Compr Psychiatry, 2014 Jan;55 Suppl 1:S38-45.
    PMID: 23602390 DOI: 10.1016/j.comppsych.2013.03.011
    OBJECTIVE: This study aimed to examine the rate and predictive factors of successful employment at 3 months upon enrolment into an employment program among patients with severe mental illness (SMI).
    METHODS: A cross-sectional study using universal sampling technique was conducted on patients with SMI who completed a 3-month period of being employed at Hospital Permai, Malaysia. A total of 147 patients were approached and 126 were finally included in the statistical analyses. Successful employment was defined as the ability to work 40 or more hours per month. Factors significantly associated with successful employment from bivariate analyses were entered into a multiple logistic regression analysis to identify predictors of successful employment.
    RESULTS: The rate of successful employment at 3 months was 68.3% (n=81). Significant factors associated with successful employment from bivariate analyses were having past history of working, good family support, less number of psychiatric admissions, good compliance to medicine, good interest in work, living in hostel, being motivated to work, satisfied with the job or salary, getting a preferred job, being in competitive or supported employment and having higher than median scores of PANNS on the positive, negative and general psychopathology. Significant predictors of employment, from a logistic regression model were having good past history of working (p<0.021; OR 6.12; [95% CI 2.1-11.9]) and getting a preferred job (p<0.032; [OR 4.021; 95% CI 1.83-12.1]).
    CONCLUSION: Results showed a high employment rate among patients with SMI. Good past history of working and getting a preferred job were significant predictors of successful employment.
    Matched MeSH terms: Outcome Assessment (Health Care)*
  12. Wah W, Wai KL, Pek PP, Ho AFW, Alsakaf O, Chia MYC, et al.
    Am J Emerg Med, 2017 Feb;35(2):206-213.
    PMID: 27810251 DOI: 10.1016/j.ajem.2016.10.042
    BACKGROUND: In out of hospital cardiac arrest (OHCA), the prognostic influence of conversion to shockable rhythms during resuscitation for initially non-shockable rhythms remains unknown. This study aimed to assess the relationship between initial and subsequent shockable rhythm and post-arrest survival and neurological outcomes after OHCA.

    METHODOLOGY: This was a retrospective analysis of all OHCA cases collected from the Pan-Asian Resuscitation Outcomes Study (PAROS) registry in 7 countries in Asia between 2009 and 2012. We included OHCA cases of presumed cardiac etiology, aged 18-years and above and resuscitation attempted by EMS. We performed multivariate logistic regression analyses to assess the relationship between initial and subsequent shockable rhythm and survival and neurological outcomes. 2-stage seemingly unrelated bivariate probit models were developed to jointly model the survival and neurological outcomes. We adjusted for the clustering effects of country variance in all models.

    RESULTS: 40,160 OHCA cases met the inclusion criteria. There were 5356 OHCA cases (13.3%) with initial shockable rhythm and 33,974 (84.7%) with initial non-shockable rhythm. After adjustment of baseline and prehospital characteristics, OHCA with initial shockable rhythm (odds ratio/OR=6.10, 95% confidence interval/CI=5.06-7.34) and subsequent conversion to shockable rhythm (OR=2.00,95%CI=1.10-3.65) independently predicted better survival-to-hospital-discharge outcomes. Subsequent shockable rhythm conversion significantly improved survival-to-admission, discharge and post-arrest overall and cerebral performance outcomes in the multivariate logistic regression and 2-stage analyses.

    CONCLUSION: Initial shockable rhythm was the strongest predictor for survival. However, conversion to subsequent shockable rhythm significantly improved post-arrest survival and neurological outcomes. This study suggests the importance of early resuscitation efforts even for initially non-shockable rhythms which has prognostic implications and selection of subsequent post-resuscitation therapy.

  13. Vitamin E in Neuroprotection Study (VENUS) Investigators, Hor CP, Fung WY, Ang HA, Lim SC, Kam LY, et al.
    JAMA Neurol, 2018 04 01;75(4):444-452.
    PMID: 29379943 DOI: 10.1001/jamaneurol.2017.4609
    Importance: Management of painful diabetic peripheral neuropathy remains challenging. Most therapies provide symptomatic relief with varying degrees of efficacy. Tocotrienols have modulatory effects on the neuropathy pathway and may reduce neuropathic symptoms with their antioxidative and anti-inflammatory activities.

    Objective: To evaluate the efficacy of oral mixed tocotrienols for patients with diabetic peripheral neuropathy.

    Design, Setting, and Participants: The Vitamin E in Neuroprotection Study (VENUS) was a parallel, double-blind, placebo-controlled trial that recruited participants from January 30, 2011, to December 7, 2014, with 12 months of follow-up. This trial screened 14 289 patients with diabetes from 6 health clinics and ambulatory care units from 5 public hospitals in Malaysia. A total of 391 patients who reported neuropathic symptoms were further assessed with Total Symptom Score (TSS) and Neuropathy Impairment Score (NIS). Patients 20 years or older with a TSS of 3 or higher and an NIS of 2 or higher were recruited.

    Interventions: Patients were randomized to receive 200 mg of mixed tocotrienols twice daily or matching placebo for 12 months. Patients with hyperhomocysteinemia (homocysteine level ≥2.03 mg/L) received oral folic acid, 5 mg once daily, and methylcobalamin, 500 μg thrice daily, in both groups.

    Main Outcomes and Measures: The primary outcome was patient-reported neuropathy TSS (lancinating pain, burning pain, paresthesia, and asleep numbness) changes at 12 months. The secondary outcomes were NIS and sensory nerve conduction test result.

    Results: Of 391 eligible patients, 300 were recruited (130 [43.3%] male; mean [SD] age, 57.6 [8.9] years; mean [SD] duration of diabetes, 11.4 [7.8] years) and 229 (76.3%) completed the trial. The TSS changes between the tocotrienols and placebo groups at 12 months (-0.30; 95% CI, -1.16 to 0.56; P = .49) were similar. No significant differences in NIS (0.60; 95% CI, -1.37 to 2.65; P = .53) and sensory nerve conduction test assessments were found between both groups. In post hoc subgroup analyses, tocotrienols reduced lancinating pain among patients with hemoglobin A1C levels greater than 8% (P = .03) and normohomocysteinemia (homocysteine level <2.03 mg/L; P = .008) at 1 year. Serious adverse events in both groups were similar, except more infections were observed in the tocotrienols group (6.7% vs 0.7%, P = .04). Results reported were of modified intention-to-treat analyses.

    Conclusions and Relevance: Supplementation of oral mixed tocotrienols, 400 mg/d for 1 year, did not improve overall neuropathic symptoms. The preliminary observations on lancinating pain among subsets of patients require further exploration.

    Trial Registration: National Medical Research Registry Identifier: NMRR-10-948-7327 and clinicaltrials.gov Identifier: NCT01973400.

  14. Viecelli AK, Howell M, Tong A, Teixeira-Pinto A, O'Lone E, Ju A, et al.
    Nephrol Dial Transplant, 2020 04 01;35(4):657-668.
    PMID: 31369099 DOI: 10.1093/ndt/gfz148
    BACKGROUND: Vascular access outcomes reported across haemodialysis (HD) trials are numerous, heterogeneous and not always relevant to patients and clinicians. This study aimed to identify critically important vascular access outcomes.

    METHOD: Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a multilanguage online survey. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7-9 being critically important). The relative importance was determined by a best-worst scale using multinomial logistic regression. Open text responses were analysed thematically.

    RESULTS: The survey was completed by 873 participants [224 (26%) patients/caregivers and 649 (74%) health professionals] from 58 countries. Vascular access function was considered the most important outcome (mean score 7.8 for patients and caregivers/8.5 for health professionals, with 85%/95% rating it critically important, and top ranked on best-worst scale), followed by infection (mean 7.4/8.2, 79%/92% rating it critically important, second rank on best-worst scale). Health professionals rated all outcomes of equal or higher importance than patients/caregivers, except for aneurysms. We identified six themes: necessity for HD, applicability across vascular access types, frequency and severity of debilitation, minimizing the risk of hospitalization and death, optimizing technical competence and adherence to best practice and direct impact on appearance and lifestyle.

    CONCLUSIONS: Vascular access function was the most critically important outcome among patients/caregivers and health professionals. Consistent reporting of this outcome across trials in HD will strengthen their value in supporting vascular access practice and shared decision making in patients requiring HD.

  15. Viecelli AK, O'Lone E, Sautenet B, Craig JC, Tong A, Chemla E, et al.
    Am J Kidney Dis, 2018 03;71(3):382-391.
    PMID: 29203125 DOI: 10.1053/j.ajkd.2017.09.018
    BACKGROUND: Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials.

    STUDY DESIGN: Systematic review.

    SETTING & POPULATION: Adults requiring maintenance hemodialysis.

    SELECTION CRITERIA: All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016.

    INTERVENTIONS: Any hemodialysis-related intervention.

    OUTCOMES: The frequency and characteristics of vascular access outcome measures were analyzed and classified.

    RESULTS: From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions.

    LIMITATIONS: Restricted sampling frame for feasibility and focus on contemporary trials.

    CONCLUSIONS: The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis.

    Matched MeSH terms: Outcome Assessment (Health Care)*
  16. Viecelli AK, Tong A, O'Lone E, Ju A, Hanson CS, Sautenet B, et al.
    Am J Kidney Dis, 2018 05;71(5):690-700.
    PMID: 29478866 DOI: 10.1053/j.ajkd.2017.12.003
    Vascular access outcomes in hemodialysis are critically important for patients and clinicians, but frequently are neither patient relevant nor measured consistently in randomized trials. A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop was convened to discuss the development of a core outcome measure for vascular access. 13 patients/caregivers and 46 professionals (clinicians, policy makers, industry representatives, and researchers) attended. Participants advocated for vascular access function to be a core outcome based on the broad applicability of function regardless of access type, involvement of a multidisciplinary team in achieving a functioning access, and the impact of access function on quality of life, survival, and other access-related outcomes. A core outcome measure for vascular access required demonstrable feasibility for implementation across different clinical and trial settings. Participants advocated for a practical and flexible outcome measure with a simple actionable definition. Integrating patients' values and preferences was warranted to enhance the relevance of the measure. Proposed outcome measures for function included "uninterrupted use of the access without the need for interventions" and "ability to receive prescribed dialysis," but not "access blood flow," which was deemed too expensive and unreliable. These recommendations will inform the definition and implementation of a core outcome measure for vascular access function in hemodialysis trials.
  17. Viecelli AK, Teixeira-Pinto A, Valks A, Baer R, Cherian R, Cippà PE, et al.
    BMC Nephrol, 2022 Nov 19;23(1):372.
    PMID: 36402958 DOI: 10.1186/s12882-022-02987-1
    BACKGROUND: A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. A validated, patient-important outcome measure for VA function that can be easily measured in research and practice to harvest reliable and relevant evidence for informing patient-centered HD care is lacking. Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) aims to assess the accuracy and feasibility of measuring a core outcome for VA function established by the international Standardized Outcomes in Nephrology (SONG) initiative.

    METHODS: VALID is a prospective, multi-center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD. The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6-month follow-up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home-, in-center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors.

    DISCUSSION: Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care.

    TRIAL REGISTRATION: Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019.

    Matched MeSH terms: Outcome Assessment (Health Care)*
  18. Umpleby AM, Shojaee-Moradie F, Fielding B, Li X, Marino A, Alsini N, et al.
    Clin Sci (Lond), 2017 Nov 01;131(21):2561-2573.
    PMID: 28923880 DOI: 10.1042/CS20171208
    Dietary sugars are linked to the development of non-alcoholic fatty liver disease (NAFLD) and dyslipidaemia, but it is unknown if NAFLD itself influences the effects of sugars on plasma lipoproteins. To study this further, men with NAFLD (n = 11) and low liver fat 'controls' (n = 14) were fed two iso-energetic diets, high or low in sugars (26% or 6% total energy) for 12 weeks, in a randomised, cross-over design. Fasting plasma lipid and lipoprotein kinetics were measured after each diet by stable isotope trace-labelling.There were significant differences in the production and catabolic rates of VLDL subclasses between men with NAFLD and controls, in response to the high and low sugar diets. Men with NAFLD had higher plasma concentrations of VLDL1-triacylglycerol (TAG) after the high (P<0.02) and low sugar (P<0.0002) diets, a lower VLDL1-TAG fractional catabolic rate after the high sugar diet (P<0.01), and a higher VLDL1-TAG production rate after the low sugar diet (P<0.01), relative to controls. An effect of the high sugar diet, was to channel hepatic TAG into a higher production of VLDL1-TAG (P<0.02) in the controls, but in contrast, a higher production of VLDL2-TAG (P<0.05) in NAFLD. These dietary effects on VLDL subclass kinetics could be explained, in part, by differences in the contribution of fatty acids from intra-hepatic stores, and de novo lipogenesis. The present study provides new evidence that liver fat accumulation leads to a differential partitioning of hepatic TAG into large and small VLDL subclasses, in response to high and low intakes of sugars.
  19. Tye SK, Kandavello G, Gan KL
    Cardiol Young, 2017 Jan;27(1):46-54.
    PMID: 26911553 DOI: 10.1017/S1047951116000068
    OBJECTIVES: The objectives of this study were to examine which types of social supports - emotional/informational support, tangible support, affectionate support, and positive interactions - are the predictors of health-related quality of life (HRQoL) in adult patients with CHD and to assess the influence of demographic variables and clinical factors on these variables.

    METHODS: In total, 205 adult patients with CHD from the National Heart Institute, Malaysia, were recruited. Patients were first screened by cardiology consultants to ensure they fit the inclusion criteria before filling in questionnaires, which were medical outcome studies - social support survey and AQoL-8D. Results/conclusions All social supports and their subscales were found to have mild-to-moderate significant relationships with physical dimension, psychological dimension, and overall HRQoL; however, only positive interaction, marital status, and types of diagnosis were reported as predictors of HRQoL. Surprisingly, with regard to the physical dimension of quality of life, social supports were not significant predictors, but educational level, marital status, and types of diagnosis were significant predictors. Positive interaction, affectionate support, marital status, and types of diagnosis were again found to be predictors in the aspects of the psychological dimension of quality of life. In conclusion, positive interaction and affectionate support, which include elements of fun, relaxation, love, and care, should be included in the care of adult patients with CHD.

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