METHODS: We performed a comparative prospective cross-sectional study assessing the impact of intravesical stent position on the quality of life in 46 patients with a ureteral stent. This is done using the Ureteral Stent Symptom Questionnaire (USSQ).
RESULTS: 52.5% of patients had an ipsilateral positioned intravesical stent, while the remaining had their stent positioned contralaterally. Intravesical stent position significantly influenced the quality of life. The USSQ score was worse for the contralateral group. Subscore analysis found that urinary symptoms and body pain index contribute significantly to the morbidity. Majority of patients in the ipsilateral group reported no discomfort as compared to the contralateral group.
CONCLUSIONS: To the best of our knowledge, this is the first study assessing the impact of intravesical stent position on the quality of life in the Asian population. Intravesical stent position has a significant influence on patient's morbidity and quality of life in particular towards their urinary irritative symptoms and body pain. It is imperative to ensure correct distal placement of ureteric stent that does not cross the midline to the contralateral site. We believe that the USSQ should be used in daily clinical practice in assessing the symptoms related to indwelling ureteric stents.
METHOD: A prospective cohort study was conducted in four of the five main MDR-TB centres in Yemen. The patients confirmed with MDR-TB completed the SF-36 V2 survey at the beginning of treatment, end of treatment (continous phase) and at the 1 year follow-up after completing treatment. A total normal base score (NBS) of
METHODS: In this randomized, double-blind, time-to-event trial, 143 adults were randomly assigned in a 2:1 ratio to receive either intravenous eculizumab (at a dose of 900 mg weekly for the first four doses starting on day 1, followed by 1200 mg every 2 weeks starting at week 4) or matched placebo. The continued use of stable-dose immunosuppressive therapy was permitted. The primary end point was the first adjudicated relapse. Secondary outcomes included the adjudicated annualized relapse rate, quality-of-life measures, and the score on the Expanded Disability Status Scale (EDSS), which ranges from 0 (no disability) to 10 (death).
RESULTS: The trial was stopped after 23 of the 24 prespecified adjudicated relapses, given the uncertainty in estimating when the final event would occur. The mean (±SD) annualized relapse rate in the 24 months before enrollment was 1.99±0.94; 76% of the patients continued to receive their previous immunosuppressive therapy during the trial. Adjudicated relapses occurred in 3 of 96 patients (3%) in the eculizumab group and 20 of 47 (43%) in the placebo group (hazard ratio, 0.06; 95% confidence interval [CI], 0.02 to 0.20; P<0.001). The adjudicated annualized relapse rate was 0.02 in the eculizumab group and 0.35 in the placebo group (rate ratio, 0.04; 95% CI, 0.01 to 0.15; P<0.001). The mean change in the EDSS score was -0.18 in the eculizumab group and 0.12 in the placebo group (least-squares mean difference, -0.29; 95% CI, -0.59 to 0.01). Upper respiratory tract infections and headaches were more common in the eculizumab group. There was one death from pulmonary empyema in the eculizumab group.
CONCLUSIONS: Among patients with AQP4-IgG-positive NMOSD, those who received eculizumab had a significantly lower risk of relapse than those who received placebo. There was no significant between-group difference in measures of disability progression. (Funded by Alexion Pharmaceuticals; PREVENT ClinicalTrials.gov number, NCT01892345; EudraCT number, 2013-001150-10.).
MATERIALS AND METHODS: Data from a randomised clinical trial evaluating efficacy of a non-surgical 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, one-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-months 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 non-surgical treatments for incontinence, reductions of 4 and 6 points in ICIQ-UI SF and ICIQ-LUTSqol respectively are perceived as clinically meaningful.
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.
STUDY DESIGN: The research was designed as a crossover, randomized control trial.
MATERIALS AND METHODS: Subjects comprised patients receiving fixed appliances at a teaching institution and indicated for VFRs. Post-treatment stone models were scanned with a structured-light scanner. A fused deposition modelling machine was used to construct acrylonitrile-butadiene-styrene (ABS)-based replicas from the 3D scanned images. VFRs were fabricated on the original stone and printed models. Analysis comprised independent t-tests and repeated measures analysis of variance.
RANDOMIZATION: Subjects were allocated to two groups using Latin squares methods and simple randomization. A week after debond, subjects received either VFR-CV first (group A) or VFR-3D first (group B) for 3 months, then the interventions were crossed over for another 3 months.
BLINDING: In this single-blinded study, subjects were assigned a blinding code for data entry; data were analysed by a third party.
OUTCOME MEASURES: The primary outcome measured was oral health-related quality of life (OHRQoL) based on Oral Health Impact Profile-14 (OHIP-14). Secondary outcome was post-treatment stability measured using Little's Irregularity Index (LII).
RESULTS: A total of 30 subjects (15 in each group) were recruited but 3 dropped out. Analysis included 13 subjects from group A and 14 subjects from group B. Group A showed an increase in LII (P < 0.05) after wearing VFR-CV and VFR-3D, whereas group B had no significant increase in LII after wearing both VFRs. Both groups reported significant improvement in OHRQoL after the first intervention but no significant differences after the second intervention. LII changes and OHIP-14 scores at T2 and T3 between groups, and overall between the retainers were not significantly different. No harm was reported during the study.
CONCLUSION: VFRs made on ABS-based 3D printed models showed no differences in terms of patients' OHRQoL and stability compared with conventionally made retainers.
REGISTRATION: NCT02866617 (ClinicalTrials.gov).
MATERIAL AND METHODS: Randomized controlled trials evaluating the effects of these 2 treatment modalities were searched from PubMed and other electronic databases between January 1991 and July 2018. The outcome variables analyzed included operating time, complications, recurrence of HH or wrap migration, reoperation, hospital stay and quality of life.
RESULTS: Five randomized controlled trials totaling 478 patients (suture=222, mesh=256) were analyzed. For reoperation variable, the odds ratio was significantly 3.26 times higher for the suture group. For recurrence of HH, the odds ratio for the suture group was nonsignificantly 1.65 times higher compared with the mesh group. Comparable effects were noted for all other variables.
CONCLUSIONS: Mesh repair seems to be superior to suture cruroplasty for large HH repair. Therefore, the routine use of mesh may be advantageous in selected cases.
METHOD: We translated into Malay a brief screening instrument for ascertainment of epilepsy designed and validated by Ottman et al., using the three-stage cross-cultural adaptation process developed by the International Quality of Life Assessment (IQOLA) project. We then administered the translated questionnaire via online survey to 162 cases (patients with epilepsy under follow-up care at the neurology clinic in University of Malaya Medical Centre, Kuala Lumpur) and 146 controls with no known history of epilepsy for validation.
RESULTS: Applying the most liberal definition for a positive screen, we obtained a sensitivity of 96.3% (95% confidence interval [CI]: 91.8-98.5%), with a specificity of 66.4% (95% CI: 58.1-73.0%) and positive predictive value (PPV) of 2.0%. The most stringent definition for a positive screen (only epilepsy) resulted in a sensitivity of 97.4% (95% CI: 62.0-72.6%), specificity of 98.6% (95% CI: 94.6-99.7%), and PPV of 26.6%. Narrowing the definition of a positive screen decreased sensitivity but improved PPVs. When compared to the original English questionnaire, the sensitivities were similar for all four definitions of a positive screen.
CONCLUSION: This is the first validated epilepsy screening questionnaire in the Malay language and represents a useful tool for the ascertainment of epilepsy in population-based studies.
METHODS: This was a prospective, cross-sectional study on spina bifida children aged 5-20 years, attending the paediatric spina bifida clinics of Universiti Kebangsaan Malaysia Medical Centre Kuala Lumpur and Hospital Tuanku Jaanku Seremban. Scores were obtained using the validated disease specific Parkin QOL questionnaire. Univariate and multivariate analysis were used to investigate factors that were determinants for these outcomes. Results were expressed as beta coefficient and 95% confidence intervals (95%CI).
RESULTS: A total of 54 children and adolescents aged between 5-20 years completed the questionnaires. Presence of neurogenic bowel (p=0.003), neurogenic bladder (p=0.041), shunt (p=0.044), non-ambulators (p=0.007) and being the only child in the family (p=0.037) were associated with lower QOL scores. Multivariate analysis showed presence of neurogenic bowel (β=0.375, 95%CI: 0.00, 0.15) and being the only child in the family (β=0.250, 95%CI: 0.04, 0.17) explained 22.1% of the variance in the QOL mean percentage scores.
CONCLUSION: Being a single child in the family was the only socio-demographic variable associated with lower QOL scores. Although several clinical factors appeared to contribute significantly to QOL in spina bifida children, the presence of neurogenic bowel had the greatest impact.
METHODS: A total of 323 dyads of GI cancer patients and their caregivers completed the Medical Outcomes Study 12-item Short Form (MOS SF-12) questionnaire to measure their HRQOL during face-to-face interviews. The analyses were performed using SF-12 scoring software to compute PCS and MCS scores (HRQOL parameters). The independent t test, one-way ANOVA, and the Pearson correlation test were conducted to determine the demographic factors related to the HRQOL of the dyads.
RESULTS: The caregivers had higher scores in all domains for the SF-12 than the patients. There were significant differences found in the MCS scores of the patients according to ethnicity, origin of cancer, duration of cancer, and surgery. None of these factors had a significant relationship with the caregivers' HRQOL.
CONCLUSION: Caregivers had better HRQOL than cancer patients. Early intervention for cancer patients in the form of counselling and personalised pain management may enhance the HRQOL of patients.
METHODS: The search strategies were performed via EBSCO MEDLINE, EBSCO CINAHL, Science Direct, PubMed, and PEDro databases from 2006 to 2016. The keywords "patient education", "low back pain", "elderly", "older adults", "older persons" and "older people" were used during the literature search. Boolean operators were used to expand or limit the searching scope and manual exclusion were performed to choose articles eligible for this study.
RESULTS: A total of 2799 articles were retrieved but only five articles were related with patient education for older people with LBP. Findings suggest that patient education for older people may differ in terms of its contents such as health education, self-management, video education, and postural education. The high methodological quality of the studies revealed that patient education showed improvement in terms of pain, disability and quality of life among older people with LBP.
CONCLUSIONS: Patient education improved pain and had positive effects on disability and quality of life among older people with LBP. However, due to the limited number of RCTs more studies are needed to provide evidence for its effectiveness.
METHOD: A cohort study was conducted where 33 severe TBI survivors recruited at two tertiary hospitals. The health-related quality of life was measured using the Quality of Life after Brain Injury (QOLIBRI) tool.
RESULTS: Participants mean age was 31.79 years old. The impaired range of health-related quality of life on 6 months post-injury seen, but an improvement occurs within 3-6 months post-injury.
CONCLUSIONS: Age and ventilation duration showed a moderate negative correlation in all domains and length of hospital stay showed a moderate negative correlation to social, daily life and self-domains. Nevertheless, small sample size and time constraint were the limitations of this study.
OBJECTIVES: This review aimed to examine the benefits and harms of human albumin infusion for treating oedema associated with nephrotic syndrome.
SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 23 June 2019 through contact with the Information Specialists using search terms relevant to this review. Studies in the Specialised Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs evaluating the effect of human albumin infusion compared with placebo or no intervention, human albumin with diuretics compared with diuretic alone, human albumin compared with diuretics and other treatments, clinical outcomes, death, quality of life, kidney function and adverse effects in people with nephrotic syndrome. We excluded cross-over studies but data for the first period was to be included if available.
DATA COLLECTION AND ANALYSIS: Standard methods of the Cochrane Collaboration were used. Two authors independently assessed eligibility, risk of bias, study quality and extracted data. We calculated mean difference (MD) for continuous data with 95% confidence intervals (CI). We assessed the certainty of the evidence using GRADE.
MAIN RESULTS: One study met our inclusion criteria (26 children with minimal change nephrotic syndrome) and 11 were excluded (nine cross-over studies, one where albumin was not used for nephrotic syndrome and one where authors did not state whether the children had oedema). Risk of bias for the included study was unclear for selection bias, high for performance and detection bias, low for attrition bias, and high for selective reporting. The included study compared albumin plus furosemide with an equal volume of dextrose. Of our prespecified outcomes, the authors reported clinical improvement as weight change, serum sodium and adverse outcomes (blood pressure). The authors reported a greater weight loss in the albumin treated group initially but no difference overall at 10 days. However, the data in the text and the figures were inconsistent so we could not confirm the authors statements (very low certainty evidence). It is uncertain whether albumin infusion improves serum sodium when compared with an equal volume of dextrose (MD 2.00 mEq/L, 95% CI -0.09 to 4.09), systolic blood pressure (MD 2.00 mmHg, 95% CI -3.52 to 7.52) or diastolic blood pressure (MD 2.00 mmHg, 95%CI -4.29 to 8.29). Death, quality of life, and kidney function were not reported.
AUTHORS' CONCLUSIONS: We identified only one small study that was relevant to our review, therefore we are unable to draw any conclusions regarding the use of human albumin with or without diuretics in nephrotic syndrome. More RCTs are needed.
METHOD: This is a cross-sectional, survey-based study in which participants responded to questionnairesregarding perceived burden (ZBI), quality of life (IEQoL), psychological distress (DASS-21), family functioning (FAD) and perceived social support (MSPSS). Additional measures include socio-demographics and clinical characteristics of the care-recipient.
RESULTS: A total of 111 caregivers participated, of whom 72.1% were females, 55% parents, 59.5% Chinese, 51.4% unemployed and 46.0% with tertiary education.Approximately half (42.3%) reported mild-to-moderate levels of burden (mean ZBI score 29.93, SD 16.09).Furthermore, multiple regression analysisidentified10 predictors of caregiver burden, namely family functioning, weekly caregiving hours, number of caregivers per family, attitude towards epilepsy, family support, caregivers' gender, personal income and as well as care-recipients' age of onset, seizure frequency and ADL dependency (F(10, 85) = 11.37, p