METHODS: A literature search of studies from online databases PubMed, Scopus, and Science Direct was conducted.
RESULTS: A total of 59 studies were selected for this review. Several studies utilised multiple assessment tools, and a total of 96 assessment tools were identified and classified into six domains: postnatal blues, postnatal stress, postnatal anxiety, postnatal depression, postnatal psychosis, and postnatal psychological disorder. In this review, EPDS was the most common tool used to identify postnatal depression and anxiety while DASS 21 was the most common tool used to identify postnatal psychological disorder. There is a wide range in preponderance of evidence for the reliability of each assessment tool and there were inconsistencies in assessing the validity of the assessment tools.
CONCLUSION: This review provides information regarding some of the main assessment tools currently available to measure postnatal mental illnesses. There were no standardised tools that were used in a particular setting. The results may differ in different population because there are differences in not only languages and dialects, but also cultural and racial backgrounds, which greatly influences their perception and interpretation of postnatal mental illness.
OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation.
METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212).
RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022.
CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.
METHODS: Participants with R/M HNSCC and no prior systemic therapy for R/M disease were randomly assigned 1:1:1 to pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy. Post hoc efficacy analyses of the PD-L1 CPS < 1 and CPS 1-19 subgroups were performed.
RESULTS: Of 882 participants enrolled, 128 had PD-L1 CPS < 1 and 373 had CPS 1-19. For pembrolizumab versus cetuximab-chemotherapy, the median overall survival was 7.9 versus 11.3 months in the PD-L1 CPS < 1 subgroup (hazard ratio [HR], 1.51 [95% CI, 0.96 to 2.37]) and 10.8 versus 10.1 months in the CPS 1-19 subgroup (HR, 0.86 [95% CI, 0.66 to 1.12]). For pembrolizumab-chemotherapy versus cetuximab-chemotherapy, the median overall survival was 11.3 versus 10.7 months in the PD-L1 CPS < 1 subgroup (HR, 1.21 [95% CI, 0.76 to 1.94]) and 12.7 versus 9.9 months in the CPS 1-19 subgroup (HR, 0.71 [95% CI, 0.54 to 0.94]).
CONCLUSION: Increased efficacy of pembrolizumab or pembrolizumab-chemotherapy was observed with increasing PD-L1 expression. PD-L1 CPS < 1 subgroup analysis was limited by small participant numbers. Results from the PD-L1 CPS 1-19 subgroup support previous findings of treatment benefit with pembrolizumab monotherapy and pembrolizumab-chemotherapy in patients with PD-L1 CPS ≥ 1 tumors. Although PD-L1 expression is informative, exploration of additional predictive biomarkers is needed for low PD-L1-expressing HNSCC.
METHODS: A cross-sectional study was conducted among type 2 DM patients. The patients were divided into three groups: no DR, non-proliferative DR (NPDR) and proliferative DR (PDR). Tears samples were collected using Schirmer strips for measurement of catalase, GPx and MDA.
RESULTS: A total of 171 patients were recruited in this study (no DR, 58 patients; NPDR, 57 patients; PDR, 56 patients). There was significant difference in the mean level of GPx in tears between the three groups (no DR, 658.08 ± 115.70 U/L; NPDR, 653.78 ± 87.90 U/L; PDR, 605.31 ± 107.47 U/L, respectively) before and after adjustment for covariates (p = 0.013 and p = 0.001, respectively). Bonferroni post-hoc analysis showed PDR group had significantly lower mean GPx level than in no DR (p=0.001) and NPDR (p=0.037) after adjustment for covariates. There was no significant difference of mean catalase and MDA in the tears between the three groups before and after adjustment for covariates.
CONCLUSION: This study demonstrated that diabetic patient with DR is associated with low level of GPx in tears, suggesting that this antioxidant enzyme is a potential biomarker for predicting the presence of DR.
DESIGN: Cross sectional analysis.
SETTING: US and Europe.
POPULATION: Sample of core outcome sets related to drugs, devices, and gene therapy that involved patients in the consensus process, published between 1 January 2015 and 31 December 2019; and corresponding EMA and FDA guidance documents.
MAIN OUTCOME MEASURES: The extent of matches between outcomes included within core outcome sets and those recommended in corresponding EMA and FDA guidance documents were assessed. Matches were considered to be general (ie, non-specific) or specific (ie, exact). General matches were assessed to determine whether the core outcome set or guidance document outcome was narrower.
RESULTS: Relevant guidance documents were found for for 38 (39%) of 98 eligible published core outcome sets. Among outcomes in core outcome sets, medians of 70% (interquartile range 48-86%) and 52% (33-77%) were matches with outcomes recommended in EMA and FDA documents, respectively. Medians of 46% (27-68%) and 26% (18-46%) were specific matches with outcomes in EMA and FDA documents, respectively. When outcomes were generally matched, the outcomes from core outcome sets were more frequently narrower than the regulatory outcomes (83% and 75% for EMA and FDA, respectively).
CONCLUSION: Greater adoption of, and reference to, core outcome sets in regulatory guidance documents can encourage clinical trialists, especially those in industry, to measure and report consistent and agreed outcomes and improve the quality of guidance. Given the overlap between outcomes in core outcome sets and regulatory guidance, and given that most core outcome sets now involve patients in the consensus process, these sets could serve as a useful resource for regulators when recommending outcomes for studies evaluating regulated products. Developers are encouraged to appraise recommended outcomes in salient regulatory documents when planning a core outcome set.
RECENT FINDINGS: The total number of personalised external aortic root support (PEARS) operations is now approaching 700 in 30 centres in Australia, Belgium, Brazil, Czech Republic, Great Britain, Greece, Ireland, Malaysia, Netherlands, New Zealand, Poland and Slovakia. There are continued reports of stability of aortic dimensions and aortic valve function with the only exceptions known being where the surgeon has deviated from the instructions for use of the device. The median root diameter of Marfan patients having PEARS was 47 mm suggesting that the existing criterion of 50 mm is due for reconsideration. The peri-operative mortality currently estimated to be less than 0.3%. The first recipient remains alive and well after 18 years. The use of PEARS as an adjunct to the Ross operation to support the pulmonary autograft is being explored in several centres.
SUMMARY: The operation requires proctoring and adherence to a strict operative protocol and with those precautions excellent results are attained. The evidence and opinions provided in the cited publications indicate that PEARS is a proven and successful prophylactic operation for aortic root aneurysm.
METHODS: This cross-sectional study was conducted in a public and two private tertiary care hospitals in Bangladesh in December 2019, including 923 consecutive patients admitted to medical and surgical departments. Face-to-face interview using a structured questionnaire was conducted to collect patient-level data. Logistic regression models were used to determine the factors associated with patients' satisfaction.
RESULTS: Patients' overall satisfaction level was 65% (51% in public and 75% in private hospitals) with a satisfaction rate of 63% in hospital staff courtesy, 56.5% in a hospital environment, 67% in physician care, 63% in general patient satisfaction, and 58% in patient's family care. Private hospitals (aOR 3.64, 95% CI 2.2-6.03), conservative management (aOR 3.34, 95% CI 2.10-5.33), shorter hospital stay (aOR 1.58, 95% CI 1.05-2.37) and perceived improvement after treatment (aOR 1.67, 95% CI 1.01-2.76) were associated with patients' satisfaction. In contrast, patients' accommodation on the floor (aOR 0.38, aOR 0.22-0.66) and high health care costs (aOR 0.97, 95% CI 0.95-0.99) were associated with patients' dissatisfaction with the in-patient service they received in both public and private hospitals.
CONCLUSION: Almost two-thirds of the patients were satisfied with the inpatient service they received, though, the satisfaction rate was higher in private hospitals. Treatment modality, cost, and outcome, as well as hospital environment like accommodation, were associated with their satisfaction level.
OBJECTIVE: To establish whether tranexamic acid compared with placebo increased the prevalence or number of remote cerebral DWIHLs within 2 weeks of ICH onset.
DESIGN, SETTING, AND PARTICIPANTS: This prospective nested magnetic resonance imaging (MRI) substudy of a randomized clinical trial (RCT) recruited participants from the multicenter, double-blind, placebo-controlled, phase 3 RCT (Tranexamic Acid for Hyperacute Primary Intracerebral Hemorrhage [TICH-2]) from July 1, 2015, to September 30, 2017, and conducted follow-up to 90 days after participants were randomized to either the tranexamic acid or placebo group. Participants had acute spontaneous ICH and included TICH-2 participants who provided consent to undergo additional MRI scans for the MRI substudy and those who had clinical MRI data that were compatible with the brain MRI protocol of the substudy. Data analyses were performed on an intention-to-treat basis on January 20, 2020.
INTERVENTIONS: The tranexamic acid group received 1 g in 100-mL intravenous bolus loading dose, followed by 1 g in 250-mL infusion within 8 hours of ICH onset. The placebo group received 0.9% saline within 8 hours of ICH onset. Brain MRI scans, including DWI, were performed within 2 weeks.
MAIN OUTCOMES AND MEASURES: Prevalence and number of remote DWIHLs were compared between the treatment groups using binary logistic regression adjusted for baseline covariates.
RESULTS: A total of 219 participants (mean [SD] age, 65.1 [13.8] years; 126 men [57.5%]) who had brain MRI data were included. Of these participants, 96 (43.8%) were randomized to receive tranexamic acid and 123 (56.2%) were randomized to receive placebo. No baseline differences in demographic characteristics and clinical or imaging features were found between the groups. There was no increase for the tranexamic acid group compared with the placebo group in DWIHL prevalence (20 of 96 [20.8%] vs 28 of 123 [22.8%]; odds ratio [OR], 0.71; 95% CI, 0.33-1.53; P = .39) or mean (SD) number of DWIHLs (1.75 [1.45] vs 1.81 [1.71]; mean difference [MD], -0.08; 95% CI, -0.36 to 0.20; P = .59). In an exploratory analysis, participants who were randomized within 3 hours of ICH onset or those with chronic infarcts appeared less likely to have DWIHLs if they received tranexamic acid. Participants with probable cerebral amyloid angiopathy appeared more likely to have DWIHLs if they received tranexamic acid.
CONCLUSIONS AND RELEVANCE: This substudy of an RCT found no evidence of increased prevalence or number of remote DWIHLs after tranexamic acid treatment in acute ICH. These findings provide reassurance for ongoing and future trials that tranexamic acid for acute ICH is unlikely to induce cerebral ischemic events.
TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN93732214.
METHODS: Face-to-face interviews were conducted with a randomly selected community sample of 992 women (>40 years old) in Selangor State, Malaysia.
RESULTS: Approximately 35% of women received a clinical breast examination (CBE) and 27% had a mammogram within the last 1 to 2 years. The regression analyses indicated that Chinese ethnicity has higher perceived susceptibility to BC compared to Malay ethnicity (mean 7.74, SD: 2.75; 95% CI 0.09, 1.03) whilst a lower perceived susceptibility was observed in women aged ≥70 years (mean 6.67, SD: 3.01; 95% CI -1.66, -0.24) compared to women aged 40-49 years. Indian Malaysian women (mean 16.87, SD: 2.59; 95% CI 0.12, 1.01) and women who had received a CBE (mean 16.10, SD:2.35; 95% CI 0.18, 0.89) were more likely to have higher perceived benefits scoring. Indian ethnicity, secondary education and tertiary education, top 20% income group, past history of CBE and mammogram uptake were significantly associated with lower barriers scoring.
CONCLUSIONS: There is a need to target BC screening uptake improvement programmes towards communities in which women experience disadvantages related to income, education, employment, and, in particular, to tailor programmes to take into consideration differences between ethnic groups regarding their beliefs about cancer screening.
OBJECTIVE: The aim of this study was to identify, review, map, and summarize findings from different types of literature reviews on the use of mobile health (mHealth) technologies to improve the uptake of cancer screening.
METHODS: The review methodology was guided by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). Ovid MEDLINE, PyscINFO, and Embase were searched from inception to May 2021. The eligible criteria included reviews that focused on studies of interventions that used mobile phone devices to promote and deliver cancer screening and described the effectiveness or implementation of mHealth intervention outcomes. Key data fields such as study aims, types of cancer, mHealth formats, and outcomes were extracted, and the data were analyzed to address the objective of the review.
RESULTS: Our initial search identified 1981 titles, of which 12 (0.61%) reviews met the inclusion criteria (systematic reviews: n=6, 50%; scoping reviews: n=4, 33%; rapid reviews: n=1, 8%; narrative reviews: n=1, 8%). Most (57/67, 85%) of the interventions targeted breast and cervical cancer awareness and screening uptake. The most commonly used mHealth technologies for increasing cancer screening uptake were SMS text messages and telephone calls. Overall, mHealth interventions increased knowledge about screening and had high acceptance among participants. The likelihood of achieving improved uptake-related outcomes increased when interventions used >1 mode of communication (telephone reminders, physical invitation letters, and educational pamphlets) together with mHealth.
CONCLUSIONS: mHealth interventions increase cancer screening uptake, although multiple modes used in combination seem to be more effective.
MATERIALS AND METHODS: The communities were selected from rural and urban populations in four peninsular states (Selangor, Kelantan, Perak, and Johor). Following a multistage sampling approach, communities in each stratum were selected according to probability proportional to the size and identified based on national census data by the community and administrative registers. Households were randomly selected. Eligible individuals were those aged between 35 and 70 years old, self-reported or identified as hypertensive at screening. Informed consent was taken. A survey using validated questionnaires was conducted.
RESULTS: The total number of respondents was 579. The mean age was 59.0 (95%: 58.4, 59.7) and more were women (71.5%) than men (28.5%). Regarding respondents selfreported level of hypertension knowledge, 2.9% reported having no knowledge at all, 80.1% had little knowledge, and 17.9% were very familiar. Among all respondents, 56.2% (95% CI: 50.7, 61.6) correctly answered at least four out of five objective knowledge questions.Almost all (91.5%) were aware that hypertension could cause a stroke. However, one-fifth believed it could cause cancer. Almost threequarters said that people with high blood pressure generally felt well (72.1%) and recognized that they should not stop taking their medication (70.7%). Most of the respondents knew that people should take their medication even if they feel well (73.6%). Although more than half (66.0%) of the respondents rated their health as poor. Interestingly, most did not perceive themselves as having a long-term illness (95.0%).
CONCLUSION: This study provides reassurance that individuals with hypertension in disadvantaged communities in Malaysia have a relatively good understanding of hypertension. Further research should explore the challenges they face on their therapeutic journeys.