METHODS AND STUDY DESIGN: A randomized controlled study was conducted on obese women with high breast adiposity (<0.1 Sm-1), aged 40-60 years in Klang Valley, Malaysia. Subjects were assigned to intervention (n=16) and control group (n=15). Intervention group received a home based health education package with close monitoring weekly, personal diet consultation and physical training in group. Assessment was ascertained at three time points; baseline, weeks 8 and 16. Outcome measures were the energy intake, physical activity, body composition, blood tests, blood biomarkers and electrical impedance tomography (EIT) quantitative values. Analyses were done using 2-way repeated measures ANOVA.
RESULTS AND CONCLUSIONS: All subjects completed the program without any drop-out. The HSI group had 100% compliance towards the intervention program; their energy intake was reduced for approximately 35% and their activity score was increased for approximately 11%. A significant interaction effect was found in body weight, body mass index (BMI), total cholesterol/HDL, vitamin C intake and matrix metallopeptidase 9 (MMP-9) (p<0.05). Interestingly, their EIT extremum values were also significantly increased indicating a reduction of breast adiposity. The intervention program was successful in improving body composition, physical activities, MMP9 and breast adipose tissue composition.
METHODS: Patients (N = 281) with schizophrenia who had completed a randomized, double-blind (DB), 6-week comparison of lurasidone (40 and 80 mg/day) and placebo were enrolled in a 26-week extension study in which all patients received open-label (OL), flexible doses of lurasidone (40 or 80 mg/day). Effectiveness was measured using the Positive and Negative Syndrome Scale (PANSS) scale.
RESULTS: Fifty-seven percent of patients completed the OL extension study; 16.7% discontinued early due to lack of effectiveness; and 10.3% due to adverse events. The most common adverse events were insomnia (11.3%), akathisia (11.0%), and nasopharyngitis (10.6%). Adverse events related to weight gain, metabolic parameters, prolactin, and ECG measures were uncommon. Mean change in the PANSS total score from the DB baseline to OL endpoint was -28.4, with mean improvement of -7.5 observed from baseline to OL endpoint, and with a PANSS responder rate of 73.7%.
DISCUSSION: The results of the current 26-week extension study found lurasidone to be a generally safe, well-tolerated, and effective long-term treatment for schizophrenia in Asian patients.
PURPOSE: To study the various surgical practices of different surgeons in the Asia-Pacific region.
OVERVIEW OF LITERATURE: Given the diversity among Asia-Pacific surgeons, there is no clear consensus on the preferred management strategies for cervical myelopathy. In particular, the role of prophylactic decompression for silent cervical spinal stenosis is under constant debate and should be addressed.
METHODS: Surgeons from the Asia-Pacific Spine Society participated in an online questionnaire comprising 50 questions. Data on clinical diagnosis, investigations and outcome measures, approach to asymptomatic and silent cervical spinal stenosis, guidelines for surgical approach, and postoperative immobilization were recorded. All parameters were analyzed by the Mantel-Haenszel test.
RESULTS: A total of 79 surgeons from 16 countries participated. Most surgeons used gait disturbance (60.5%) and dyskinetic hand movement (46.1%) for diagnosis. Up to 5.2% of surgeons would operate on asymptomatic spinal stenosis, and 18.2% would operate on silent spinal stenosis. Among those who would not operate, most (57.1%) advised patients on avoidance behavior and up to 9.5% prescribed neck collars. For ossification of the posterior longitudinal ligament (OPLL), anterior removal was most commonly performed for one-level disease (p<0.001), whereas laminoplasty was most commonly performed for two- to four-level disease (p=0.036). More surgeons considered laminectomy and fusion for multilevel OPLL. Most surgeons generally preferred to use a rigid neck collar for 6 weeks postoperatively (p<0.001).
CONCLUSIONS: The pooled recommendations include prophylactic or early decompression surgery for patients with silent cervical spinal stenosis, particularly OPLL. Anterior decompression is primarily suggested for one- or two-level disease, whereas laminoplasty is preferred for multilevel disease.
Purpose: To investigate the effects of 'graded exercise integrated with education' on physical fitness, exercise self-efficacy (ESE), and physical activity (PA) levels among subacute and chronic wheelchair-dependent paraplegia patients.
Overview of Literature: Most of the chronic spinal cord injury (SCI) patients had low physical fitness due to a sedentary lifestyle and lack of ESE after discharge from a rehabilitation program. Education may encourage them to engage with exercise to regain and maintain their physical fitness. However, there is a lack of research to support the effects of exercise integrated with education after an SCI.
Methods: A total of 44 participants will be assigned to either the experimental group (graded exercise integrated with education) or active control (conventional physical therapy). The experimental group will receive graded strength and aerobic exercise training according to their progression criteria. They will attend an education program during and after the rehabilitation program. The control group will only receive conventional physical therapy during their in-rehabilitation program. This study will be conducted during a period of 16 weeks, consisting of 8 weeks of in-rehabilitation and 8 weeks post-rehabilitation. Statistical analysis will be performed using the IBM SPSS ver. 21.0 (IBM Corp., Armonk, NY, USA) at a significance level of p≤0.05.
Results: The primary outcome measures will be upper-limb isokinetic strength, isometric grip strength, and cardiorespiratory fitness. The secondary outcomes will be ESE and PA levels.
Conclusions: An intervention that combines exercise training and education may be warranted to enhance the physical fitness, ESE, and PA levels in SCI patients. This trial was registered with ClinicalTrials.gov (NCT03420170).
METHODS: A non-blinded, randomised controlled trial will be conducted. A total of sixty-six patients who fulfil the inclusion criteria will be recruited. The participants will be randomly allocated into intervention (traditional Malay massage) and control (relaxation position) groups. Blood and saliva samples will be collected before and immediately after intervention. All collected samples will be analysed. The primary outcomes are the changes in the level of substance P in both saliva and blood samples between both groups. The secondary outcomes include the levels of inflammatory mediators [i.e. TNF-α, IL-1β, IL-8, monocyte chemotactic protein-1, IL-6 and IL-10, and the soluble form of the intercellular adhesion molecule], the pain intensity as measured by a visual analogous scale and functional outcomes using the Roland-Morris Disability Questionnaire.
DISCUSSION: Massage is a type of physical therapy that has been proven to be potentially capable of reducing unpleasant pain sensations by a complex sensory response and chemical mediators such as substance P and various inflammatory mediators. Previous studies conducted using Thai, Swedish, or other forms of massage therapies, have showed inconsistent findings on substance P levels pre and post the interventions. Each massage genre varies in terms of massage and joint mobilization points, as well as the lumbar spinous process. Traditional Malay massage, known locally as "Urut Melayu", involves soft-tissue manipulation of the whole body applied using the hands and fingers. This massage technique combines both deep muscular tissue massage and spiritual rituals. This trial is expected to give rise to new knowledge underlying the mechanisms for pain and inflammation relief that are activated by traditional Malay massage.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials ACTRN12615000537550 .
METHODS: We searched PubMed, Scopus, EMBASE, CINAHL, and Cochrane Library for relevant articles published from inception to 28th February 2021. All authors were involved in the screening and selection of studies. Original studies investigating the therapeutic, humanistic, safety, and economic impact of clinical pharmacists in Pakistani patients (hospitalised or outpatients) were selected. Two reviewers independently assessed the risk of bias in studies, and discrepancies were resolved through mutual consensus. All of the included studies were descriptively synthesised, and PRISMA reporting guidelines were followed.
RESULTS: The literature search found 751 articles from which nine studies were included; seven were randomized controlled trials (RCTs), and two were observational studies. Three RCTs included were having a low risk of bias (ROB), two RCTs were having an unclear ROB, while two RCTs were having a high ROB. The nature of clinical pharmacist interventions included one or more components such as disease-related education, lifestyle changes, medication adherence counselling, medication therapy management, and discussions with physicians about prescription modification if necessary. Clinical pharmacist interventions reduce medication-related errors, improve therapeutic outcomes such as blood pressure, glycemic control, lipid control, CD4 T lymphocytes, and renal functions, and improve humanistic outcomes such as patient knowledge, adherence, and health-related quality of life. However, no study reported the economic outcomes of interventions.
CONCLUSIONS: The findings of the studies included in this systematic review suggest that clinical pharmacists play important roles in improving patients' health outcomes in Pakistan; however, it should be noted that the majority of the studies have a high risk of bias, and more research with appropriate study designs is needed.
METHODS: An interdisciplinary and international Working Group was assembled. Existing literature and current measurement initiatives were reviewed. Serial guided discussions and validation surveys provided consumer input. A series of nine teleconferences, incorporating a modified Delphi process, were held to reach consensus on the proposed Standard Set.
RESULTS: The Working Group selected 24 outcome measures to evaluate care during pregnancy and up to 6 months postpartum. These include clinical outcomes such as maternal and neonatal mortality and morbidity, stillbirth, preterm birth, birth injury and patient-reported outcome measures (PROMs) that assess health-related quality of life (HRQoL), mental health, mother-infant bonding, confidence and success with breastfeeding, incontinence, and satisfaction with care and birth experience. To support analysis of these outcome measures, pertinent baseline characteristics and risk factor metrics were also defined.
CONCLUSIONS: We propose a set of outcome measures for evaluating the care that women and infants receive during pregnancy and the postpartum period. While validation and refinement via pilot implementation projects are needed, we view this as an important initial step towards value-based improvements in care.
METHODS: A 28-item instrument which comprised of 5 domains: diabetes, hypertension, hyperlipidemia, medications and general issues was designed and tested. One point was given for every correct answer, whilst zero was given for incorrect answers. Scores ranged from 0 to 28, which were then converted into percentage. This was administered to 77 patients with type 2 diabetes in a tertiary hospital, who were on medication(s) for diabetes and who could understand English (patient group), and to 40 pharmacists (professional group). The DHL knowledge instrument was administered again to the patient group after one month. Excluded were patients less than 18 years old.
RESULTS: Flesch reading ease was 60, which is satisfactory, while the mean difficulty factor(SD) was 0.74(0.21), indicating that DHL knowledge instrument was moderately easy. Internal consistency of the instrument was good, with Cronbach's α = 0.791. The test-retest scores showed no significant difference for 26 out of the 28 items, indicating that the questionnaire has achieved stable reliability. The overall mean(SD) knowledge scores was significantly different between the patient and professional groups [74.35(14.88) versus 93.84(6.47), p < 0.001]. This means that the DHL knowledge instrument could differentiate the knowledge levels of participants. The DHL knowledge instrument shows similar psychometric properties as other validated questionnaires.
CONCLUSIONS: The DHL knowledge instrument shows good promise to be adopted as an instrument for assessing diabetic patients' knowledge concerning their disease conditions and medications in Malaysia.
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.
METHODS: In this cross-sectional study among 570 YMSM aged 18 to 25 years old, latent class analysis (LCA) conducted to identify classes with similar patterns of sexualized substance use, across which measures of inconsistent condom use, recent STI diagnoses, past suicide ideation and depression severity were compared.
RESULTS: LCA revealed three classes of YMSM based on types of substances ever used in sexualized contexts, which we labelled as 'substance-naive', 'substance-novice', and 'chemsex'. Substance-naive participants (n = 404) had only ever used alcohol, while substance-novice participants (n = 143) were primarily amyl nitrite users with a small proportion who reported using chemsex-related drugs. Chemsex participants (n = 23) comprised individuals who had mostly used such drugs. Those in the chemsex group were more likely to report recent unprotected anal sex with casual partners (aPR = 3.28, 95%CI [1.85, 5.79]), depression severity (aβ = 3.69, 95%CI [0.87, 6.51]) and a history of suicide ideation (aPR = 1.64, 95%CI [1.33, 2.03]).
CONCLUSIONS: Findings of this study highlight how the use of varying substances in sexualized contexts may be classified and characterized by different sexual and mental health outcomes. Health promotion efforts should be differentiated accordingly to address the risks associated with sexualized substance use among YMSM.