METHODS: A retrospective review was conducted on 99 women who underwent Surelift System surgery for advanced POP Stage III and IV between July 2018 to January 2020. Objective evaluation included Pelvic Organ Prolapse Quantification (POP-Q), multichannel urodynamic (UDS), and introital 2D ultrasonographic measurement. Subjective evaluation uses validated questionnaires of Incontinence Impact Questionnaire-7(IIQ-7), Urogenital Distress Inventory-6(UDI-6), Pelvic Organ Prolapse Distress Inventory 6(POPDI-6), Colorectal Anal Distress Inventory-8(CRADI-8) and Pelvic organ prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12). Outcomes were examined at 3 months, yearly and at 3 years postoperative. Secondary outcome included de novo or persistent urodynamic stress incontinence (USI) and surgical complications.
RESULTS: Eighty-five women were included in the final analysis. At 3 years postoperative, the objective cure rate was 94.1 % and subjective cure rate of 91.8 %. Ultrasonography revealed initial mesh elongation and thickening at first year, resolving by the third year, while the distance between the bladder neck and mesh remained stable. Significant improvement in POP-Q components (Aa,Ba,C,Ap,Bp and TVL of p Life (QoL) questionnaires (p
OBJECTIVES: This study aimed to assess the feasibility and acceptability of integrating clinical pharmacists into the multidisciplinary team (MDT) to manage cancer pain and assess preliminary outcomes in cancer patients receiving pain treatment. This pilot study was undertaken to inform a future definitive randomized controlled trial (RCT).
METHODS: The protocol was registered with ClinicalTrials.gov (NCT05021393). The PharmaCAP trial was conducted in two oncology centers in Nepal, where patients were randomly enrolled into usual care (UC) or an intervention group (PharmaCAP). The latter received a clinical pharmacist-led medication review, which involved a comprehensive assessment of the patient's current medications, identification of potential drug-related problems, and personalized recommendations for optimizing pain management. This was accompanied by pain assessment, education and counseling on pain management strategies. Baseline and 4-weeks post-intervention assessments measured primary outcomes, i.e., feasibility metrics (recruitment of the patients, retention of patients, patient satisfaction). Secondary outcomes included pain intensity, health-related QoL, anxiety, depression, barriers to pain management, and medication adherence at 4 weeks.
RESULTS: Out of 140 screened patients, 108 were evaluated for eligibility, with 16 opting out primarily due to lack of interest (n = 11) and communication barriers (n = 5). A total of ninety-two participants with cancer pain were randomized into two groups, with 91 patients successfully recruited and 85 (93.4%) completing 4 weeks post-intervention assessment). Completion rates for the UC and PharmaCAP groups were 91.3% and 93.4%, respectively. The primary feasibility outcomes were positive: 100% of patients found random allocation acceptable. Retention rates were high, with 91.3% in the UC group and 93.4% in the PharmaCAP group, despite a few dropouts due to being unreachable, COVID-related issues, and changes in treatment centers. No evidence of contamination between groups was found, as participants did not discuss interventions or influence each other's attitudes, ensuring effective isolation of interventions The PharmaCAP intervention showed significant improvement in QoL (P
OBJECTIVES: To assess the clinical effects, including adverse effects, of galantamine in people with probable or possible Alzheimer's disease or mild cognitive impairment, and to investigate potential moderators of effect.
SEARCH METHODS: We systematically searched the Cochrane Dementia and Cognitive Improvement Group's Specialised Register on 14 December 2022 using the term 'galantamine'. The Register contains records of clinical trials identified from major electronic databases (including CENTRAL, MEDLINE, and Embase), trial registries, grey literature sources, and conference proceedings. We manually searched reference lists and collected information from US Food and Drug Administration documents and unpublished trial reports. We imposed no language restrictions.
SELECTION CRITERIA: We included double-blind, parallel-group, randomised controlled trials comparing oral galantamine with placebo for a treatment duration exceeding four weeks in people with dementia due to Alzheimer's disease or with mild cognitive impairment.
DATA COLLECTION AND ANALYSIS: Working independently, two review authors selected studies for inclusion, assessed their quality, and extracted data. Outcomes of interest included cognitive function, change in global function, activities of daily living, functional disability, behavioural function, and adverse events. We used a fixed-effect model for meta-analytic synthesis, and presented results as Peto odds ratios (OR) or weighted mean differences (MD) with 95% confidence intervals. We used Cochrane's original risk of bias tool (RoB 1) to assess the risk of bias in the included studies.
MAIN RESULTS: We included 21 studies with a total of 10,990 participants. The average age of participants was 74 years, and 37% were male. The studies' durations ranged from eight weeks to two years, with 24 weeks being the most common duration. One newly included study assessed the effects of galantamine at two years, and another newly included study involved participants with severe Alzheimer's disease. Nineteen studies with 10,497 participants contributed data to the meta-analysis. All studies had low to unclear risk of bias for randomisation, allocation concealment, and blinding. We judged four studies to be at high risk of bias due to attrition and two due to selective outcome reporting. Galantamine for dementia due to Alzheimer's disease We summarise only the results for galantamine given at 8 to 12 mg twice daily (total galantamine 16 mg to 24 mg/day), assessed at six months. See the full review for results of other dosing regimens and assessment time points. There is high-certainty evidence that, compared to placebo, galantamine improves: cognitive function, as assessed with the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) (MD-2.86, 95% CI -3.29 to -2.43; 6 studies, 3049 participants; minimum clinically important effect (MCID) = 2.6- to 4-point change); functional disability, as assessed with the Disability Assessment for Dementia (DAD) scale (MD 2.12, 95% CI 0.75 to 3.49; 3 studies, 1275 participants); and behavioural function, as assessed with the Neuropsychiatric Inventory (NPI) (MD -1.63, 95% CI -3.07 to -0.20; 2 studies, 1043 participants) at six months. Galantamine may improve global function at six months, as assessed with the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus) (OR 1.58, 95% CI 1.36 to 1.84; 6 studies, 3002 participants; low-certainty evidence). Participants who received galantamine were more likely than placebo-treated participants to discontinue prematurely (22.7% versus 17.2%) (OR 1.41, 95% CI 1.19 to 1.68; 6 studies, 3336 participants; high-certainty evidence), and experience nausea (20.9% versus 8.4%) (OR 2.89, 95% CI 2.40 to 3.49; 7 studies, 3616 participants; high-certainty evidence) during the studies. Galantamine reduced death rates at six months: 1.3% of participants in the galantamine groups had died compared to 2.3% in the placebo groups (OR 0.56, 95% CI 0.33 to 0.96; 6 studies, 3493 participants; high-certainty evidence). Galantamine for mild cognitive impairment We summarise results, assessed at two years, from two studies that gave participants galantamine at 8 to 12 mg twice daily (total galantamine 16 mg to 24 mg/day). Compared to placebo, galantamine may not improve cognitive function, as assessed with the expanded ADAS-cog for mild cognitive impairment (MD -0.21, 95% CI -0.78 to 0.37; 2 studies, 1901 participants; low-certainty evidence) or activities of daily living, assessed with the Alzheimer's Disease Cooperative Study - Activities of Daily Living scale for mild cognitive impairment (MD 0.30, 95% CI -0.26 to 0.86; 2 studies, 1901 participants; low-certainty evidence). Participants who received galantamine were probably more likely to discontinue prematurely than placebo-treated participants (40.7% versus 28.6%) (OR 1.71, 95% CI 1.42 to 2.05; 2 studies, 2057 participants) and to experience nausea (29.4% versus 10.7%) (OR 3.49, 95% CI 2.75 to 4.44; 2 studies, 2057 participants), both with moderate-certainty evidence. Galantamine may not reduce death rates at 24 months compared to placebo (0.5% versus 0.1%) (OR 5.03, 95% CI 0.87 to 29.10; 2 studies, 2057 participants; low-certainty evidence). Results from subgroup analysis and meta-regression suggest that an imbalance in discontinuation rates between galantamine and placebo groups, together with the use of the 'last observation carried forward' approach to outcome assessment, may potentially bias cognitive outcomes in favour of galantamine.
AUTHORS' CONCLUSIONS: Compared to placebo, galantamine (when given at a total dose of 16 mg to 24 mg/day) slows the decline in cognitive function, functional ability, and behaviour at six months in people with dementia due to Alzheimer's disease. Galantamine probably also slows declines in global function at six months. The changes observed in cognition, assessed with the ADAS-cog scale, were clinically meaningful. Gastrointestinal-related adverse events are the primary concerns associated with galantamine use in people with dementia, which may limit its tolerability. Although death rates were generally low, participants in the galantamine groups had a reduced risk of death compared to those in the placebo groups. There is no evidence to support the use of galantamine in people with mild cognitive impairment.
DESIGN, PATIENTS AND MEASUREMENTS: Patients with AI on twice-daily hydrocortisone, who had low or moderate risk and intended to fast, were recruited. Patients were converted to prednisolone 5 mg once daily taken at sahur (predawn) and Ramadan education given. Weight, sleep duration, biochemical parameters and quality of life measures (SF-36 questionnaire) were analysed at the end of Ramadan and compared against baseline.
RESULTS: Twenty patients (13 men) were recruited, with a mean age of 59.9 ± 15.0 years. All patients were on hydrocortisone 15 mg daily (in divided doses) as pre-Ramadan glucocorticoid replacement. Half had type 2 diabetes with low IDF-DAR risk. Eighty-five percent of patients completed the full 29 days of fasting with no complications. There was a significant reduction in weight (-1.1 ± 1.6 kg, p = .005), with no significant change in blood pressure or sleep duration. There was a significant increase in urea (0.80 ± 1.1 mmol/L, p = .005) and haematocrit, (0.011 ± 0.019 L/L, p = .019) and decrease in serum sodium (-1.6 ± 3.0 mmol/L, p = .028), with no change in serum creatinine or liver function. Quality of life measures were preserved in all domains with significant improvement in role limitation due to physical health (15.3 ± 21.6, p = .005) and bodily pain (8.8 ± 16.3, p = .031).
CONCLUSIONS: This study has demonstrated that converting patients with AI who are fasting for Ramadan from twice-daily hydrocortisone to prednisolone 5 mg daily at sahur was safe, with no major short-term adverse effects. Despite the higher equivalent glucocorticoid doses, patients experienced weight loss and no clinically significant change in blood pressure, sleep, biochemical parameters or quality of life. This study paves the way to trial even lower doses of prednisolone once daily in patients fasting for Ramadan with AI.
OBJECTIVE: To compare pain scores at 6 and 24 h postoperatively between laser closure and ligation of the intersphincteric tract for anal fistula.
DESIGN: Prospective, double-blinded randomized controlled trial.
SETTINGS: A quaternary hospital in Malaysia.
PATIENTS: Patients aged 18-75 years with high transsphincteric fistulas.
INTERVENTION: Fistula laser closure versus ligation of the fistula tract (LIFT) treatment.
MAIN OUTCOME MEASURES: Pain scores, continence, quality of life (QOL), operative time, and treatment failure were compared using chi-square, Fisher's exact test, student t-test, or Mann-Whitney with p 0.05).
LIMITATIONS: Patients with prior fistula surgery (approximately 20%) led to heterogeneity. The total laser energy delivered varied depending on fistula anatomy.
CONCLUSION: Laser fistula closure is an alternative to LIFT, with similar postoperative pain and shorter operative time despite more complex fistula anatomy in the laser arm, with a greater improvement in QOL.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06212739.
METHODS: PubMed, Web of Science, and Google Scholar databases were explored to find related articles. Search terms were amputees, artificial limb, prosthetic suspension, prosthetic liner, vacuum, and prosthesis. The results were refined by vacuum socket or vacuum assisted suspension or sub-atmospheric suspension. Study design, research instrument, sample size, and outcome measures were reviewed. An online questionnaire was also designed and distributed worldwide among professionals and prosthetists (www.ispoint.org, OANDP-L, LinkedIn, personal email).
FINDINGS: 26 articles were published from 2001 to March 2016. The number of participants averaged 7 (SD=4) for transtibial and 6 (SD=6) for transfemoral amputees. Most studies evaluated the short-term effects of vacuum systems by measuring stump volume changes, gait parameters, pistoning, interface pressures, satisfaction, balance, and wound healing. 155 professionals replied to the questionnaire and supported results from the literature. Elevated vacuum systems may have some advantages over the other suspension systems, but may not be appropriate for all people with limb loss.
INTERPRETATION: Elevated vacuum suspension could improve comfort and quality of life for people with limb loss. However, future investigations with larger sample sizes are needed to provide strong statistical conclusions and to evaluate long-term effects of these systems.
Methods: This was a cross-sectional study of patients with COPD attending the respiratory medicine clinic of University of Malaya Medical Centre from 1 June 2017 to 31 May 2018. Disease-specific HRQoL was assessed by using the COPD Assessment Test (CAT) and St George's Respiratory Questionnaire for COPD (SGRQ-c).
Results: Of 189 patients, 28.6% were of non-exacerbator phenotype (NON-AE), 18.5% were of exacerbator with emphysema phenotype (AE NON-CB), 39.7% were of exacerbator with chronic bronchitis phenotype (AE CB), and 13.2% had asthma-COPD overlap syndrome phenotype (ACOS). The total CAT and SGRQ-c scores were significantly different between the clinical phenotypes (P<0.001). Patients who were AE CB had significantly higher total CAT score than those with ACOS (P=0.033), AE NON-CB (P=0.001), and NON-AE (P<0.001). Concerning SGRQ-c, patients who were AE CB also had a significantly higher total score than those with AE NON-CB (P=0.001) and NON-AE (P<0.001). However, the total SGRQ-c score of AE CB patients was only marginally higher than those who had ACOS (P=0.187). There was a significant difference in the score of each CAT item (except CAT 7) and SGRQ-c components between clinical phenotypes, with AE CB patients recording the highest score in each of them.
Conclusion: Patients who were AE CB had significantly poorer HRQoL than other clinical phenotypes and recorded the worst score in each of the CAT items and SGRQ-c components. Therefore, AE CB patients may warrant a different treatment approach that focuses on the exacerbation and chronic bronchitis components.
DESIGN: Cross-sectional study.
SETTING: Three public primary care clinics in a district in Selangor, Malaysia.
PARTICIPANTS: Registered patients aged 55 years and above.
MEASUREMENTS: A face-to-face interview was conducted using a validated questionnaire of Medical Outcome Study 36-item short form health survey (SF-36). The outcome measure was the health related quality of life (HRQoL) and other factors measured were socio demography, physical activity, social support (Duke-UNC Functional Social Support Questionnaire), and presence of non-communicable diseases.
RESULTS: A total of 347 participants had non-communicable diseases which included hypertension (41.8%), type 2 diabetes (33.7%), asthma (4.8%), hyperlipidaemia (1.7%), coronary heart disease (1.2%), and osteoarthritis (0.2%). Age ≥ 65 years old (OR =2.23; 95%CI=1.42, 3.50), single (OR=1.75; 95%CI=1.06,2.90), presence of co-morbid condition (OR=1.66; 95%CI=1.06, 2.61), and poorer social support (OR=2.11; 95%CI=1.27, 3.51; p=0.002) were significant predictors of poorer physical component of HRQoL . In predicting lower mental health component of HRQoL, the significant predictors were women (OR=2.28; 95%CI=1.44, 3.62), Indian ethnicity (OR=1.86; 95%CI=1.08, 3.21) and poorer social support (OR=2.71; 95%CI=1.63, 4.51). No interactions existed between these predictors.
CONCLUSION: Older people with non-communicable diseases were susceptible to lower health related quality of life. Increasing age, single, presence of co-morbid conditions, and poorer social support were predictors of lower physical health component of HRQoL. While the older women, Indian ethnicity and poorer social support reported lower mental health component of HRQoL.