What information and the extent of information research participants need in informed consent forms: a multi-country survey.

BACKGROUND: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. METHODS: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). RESULTS: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). CONCLUSIONS: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

Improving metabolic monitoring in patients maintained on antipsychotics in Penang, Malaysia.

OBJECTIVES: To evaluate the monitoring of metabolic parameters among outpatients maintained on antipsychotic medications in a general hospital setting in Malaysia and to assess the impact of a local monitoring protocol. METHODS: By performing a baseline audit of files from a random sample of 300 patients prescribed antipsychotic medications for at least 1 year; we determined the frequency of metabolic monitoring. The findings informed the design of a new local protocol, on which clinical staff was briefed. We re-evaluated metabolic monitoring immediately after implementation, in a small sample of new referrals and current patients. We explored staff perceptions of the initiative with a follow-up focus group, 6 months post-implementation. RESULTS: The baseline audit revealed a sub-optimal frequency of metabolic parameter recording. Re-audit, following implementation of the new protocol, revealed improved monitoring but persisting deficits. Dialogue with the clinical staff led to further protocol modification, clearer definition of staff roles and use of a standard recording template. Focus group findings revealed positive perceptions of the initiative, but persisting implementation barriers, including cultural issues surrounding waist circumference measurement. CONCLUSIONS: Responding to challenges in achieving improved routine metabolic monitoring of patients maintained on antipsychotics required on-going dialogue with the clinical staff, in order to address both service pressures and cultural concerns.

Comparing the efficacy of tocilizumab with corticosteroid therapy in treating COVID-19 patients: a systematic review and meta-analysis.

PURPOSE: Tocilizumab has shown equivocal outcomes in reducing mortality in COVID-19. The corticosteroids appear to be an affordable alternative to tocilizumab. This study aims to estimate the efficacy of tocilizumab and the corticosteroids particularly dexamethasone and methylprednisolone and to identify possible determinants of their efficacy. METHODS: Five electronic databases were searched for studies involving tocilizumab, dexamethasone, and methylprednisolone in treating COVID-19. We included case-control and randomized or partially randomized trials. Meta-regression for patient baseline characteristics, co-medications, and tocilizumab dose regimens was performed to identify contributing factors to drug efficacy. RESULTS: Thirteen randomized controlled trials (RCTs) and twenty-four case-control studies were included in our meta-analysis involving 18,702 patients. Meta-analysis among the RCTs showed that a summary estimate favoring mortality reduction (OR 0.71, 95%CI 0.55 - 0.92) contributed mainly by tocilizumab and dexamethasone. Among case-control studies, meta-analysis showed mortality reduction (OR 0.52, 95%CI 0.36 - 0.75) contributed by tocilizumab and tocilizumab-methylprednisolone combination. Methylprednisolone alone did not reduce mortality except for one study involving high dose pulse therapy. Meta-analysis also found that all three drugs did not significantly reduce mechanical ventilation (OR 0.72, 95%CI 0.32 - 1.60). CONCLUSION: Tocilizumab and dexamethasone emerge as viable options in reducing mortality in severe COVID-19 patients. A tocilizumab-corticosteroid combination strategy may improve therapeutic outcome in cases where single therapy fails.

Maternal and perinatal guideline development in hospitals in South East Asia: results from the SEA-ORCHID project.

BACKGROUND: Recognising the potential of clinical practice guidelines (CPGs) to improve practice, one of the strategies of the SEA-ORCHID project was to facilitate the development of evidence-based CPGs, and to support clinical staff in each of the four countries to build their skills in development of CPGs in the nine participating hospitals in Thailand, Malaysia, Philippines and Indonesia. This study was undertaken to investigate the impact of the SEA-ORCHID project on development of evidence-based CPGs. METHODS: Data on the CPGs available to support maternal and perinatal healthcare were collected by SEA-ORCHID team members at each hospital before and after the intervention period of the project. RESULTS: There were only a few evidence-based CPGs available in the SEA-ORCHID hospitals before the intervention period. After the intervention period, in the SEA-ORCHID hospitals in Malaysia and Indonesia there was no change in evidence-based CPG development activity in maternal and perinatal care. In Thailand and The Philippines there was a small increase in evidence-based CPG development activity in maternal and perinatal care. CONCLUSION: Despite the wide range of interventions to support evidence-based CPG development implemented in the hospitals participating in the SEA-ORCHID, very little change was seen in the development of evidence-based CPGs.

Evaluation of illness perceptions and their associations with glycaemic control, medication adherence and chronic kidney disease in type 2 diabetes mellitus patients in Malaysia.

BACKGROUND: Illness perceptions (IP) involve coping strategies and behavioural responses that can influence glycaemic control. Despite the importance of good glycaemic control, the majority of patients in Asia are not achieving glycaemic targets. An evaluation of IP in association with glycaemic control, medication adherence and chronic kidney disease (CKD) in Type 2 diabetes mellitus patients (T2DM) was carried out in an outpatient setting in Malaysia METHOD: A cross-sectional study was conducted using the Revised Illness Perception Questionnaire in a purposive sample of 384 T2DM patients. RESULTS: There were 55.7% females, median age was 58.2 years and median duration of diabetes was 13 years. The majority (79.4%) of patients had poor diabetes control (HbA1c ≥ 7.0%) and 39.6% of patients had low medication adherence. Patients with good glycaemic control had a higher Timeline Acute/Chronic and Emotional Representations score, hence they held the correct belief that diabetes is chronic and experienced negative emotions. Highly adherent patients had a higher Illness Coherence (χ2 = 21.385, p < 0.001) score but a lower Consequences (χ2 = 17.592, p < 0.001) and Emotional Representations (χ2 = 16.849, p < 0.001) score indicating good understanding and less negative perceptions of disease burden. Patients in a more advanced stage of CKD had a significantly higher Timeline Cyclical score (χ2 = 18.718, p = 0.001), believing that diabetes was unpredictable. CONCLUSION: Dimensions of IP have been shown to be significantly associated with the assessed variables, therefore intervention studies with education, support and counselling should be conducted in Asia with the ultimate aim of empowering patients through IP-targeted management.

A psychologist-led educational intervention results in a sustained reduction in neonatal intensive care unit infections.

UNLABELLED: Even though in the corporate world psychological science has been widely used, the formal use of evidence-based psychology in important areas of clinical medicine has been scanty at best. It was the aim of this study to determine the efficacy of a psychologist-led 2-week nurse educator training on the infection rate in the neonatal intensive care unit (NICU). MATERIALS AND METHODS: In 2007, six senior neonatal nurses underwent a training course focusing on the retrieval of evidence and knowledge of psychological principles that would allow them to share the evidence in such a way that evidence is effectively brought into practice. The course was led by a psychologist. The nurses created and delivered their own teaching modules, all focused on infection control. The rates of bacteremia, 2 years prior to intervention were analyzed and compared with the rate following the intervention for 3 years. RESULTS: The immediate output of the course included three teaching modules: hand washing, sterile procedures, and general measures to control infection. These modules were subsequently administered to the NICU nurses in regular structured continuous nursing education sessions. The psychological techniques taught in the course were applied. Bacteremia in the NICU significantly decreased in the year of the course and the subsequent years when compared to previous years (from more than 17 in 2005 and 2006 to less than 10 per 100 admissions to the NICU in 2008 and 2009). CONCLUSION: This study suggests that a psychologist-led course, followed by a structured CNE can lead to a sustainable reduction in infection rates in a NICU.