BackgroundThe 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.MethodsThis 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).ResultsOf 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).ConclusionsResearch 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.Electronic supplementary materialThe online version of this article (10.1186/s12910-018-0318-x) contains supplementary material, which is available to authorized users.

Purpose: A recent 3-month randomized, open-label controlled trial found that the intra-articular hyaluronic acid injection (GO-ON®) given as a single dose of 5 mL is as effective and safe as three repeated doses of 2.5 mL in patients with knee osteoarthritis. However, the information on the long-term efficacy and economic implications of the single-dose regimen is still limited. Hence, this follow-up study was designed to compare the effectiveness and costs of the two regimens 12 months following the treatment. Methods: All the 127 patients, who received either three repeated doses ( n = 64) or a single dose ( n = 63) of GO-ON in the previous trial, were followed up in month 12 following the treatment. The effectiveness of both the regimens was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the mean WOMAC scores were compared with those recorded at the baseline and in month 3. Additionally, the total treatment costs of the two regimens, taking account of both direct and indirect costs, were computed and compared. Results: A total of 125 patients (98.4%) completed the assessment. Despite the reduction of the overall mean WOMAC score from 39.24 to 19.93 ( p < 0.001) in the first 3 months following the treatment with GO-ON, no further changes were observed up to month 12 ( p > 0.95). In the meantime, the two regimens did not differ in the mean WOMAC scores ( p = 0.749) and in the subscale scores for pain ( p = 0.970), stiffness ( p = 0.526), and physical functioning ( p = 0.667) in month 12. The cost for single-dose injection was found to be approximately 30% lower compared to the repeated doses. Conclusion: These findings indicate that the single larger dose of GO-ON is as effective as the repeated doses over 12 months, and yet the total treatment cost is lowered.

Background Minor ailments are defined as common, self-limiting, or uncomplicated conditions that may be diagnosed and managed without a medical intervention. Previous studies reported that pharmacists were able to help patients self-manage minor ailments that led to a reduction of health care burden in other facilities. Nevertheless, public access to community pharmacy and other health care facilities offering services for minor ailments has not yet been explored in Malaysia. Hence, this study aims to determine population access to the above-mentioned services. Method According to the reported practice address in 2018, the spatial distribution of health care facilities was mapped and explored using the GIS mapping techniques. The density of health care facilities was analyzed using thematic maps with hot spot analysis. Population to facility ratio was calculated using the projection of the population growth based on 2010 census data, which was the latest available in the year of analysis. Results The study included geographical mapping of 7051 general practitioner clinics (GPC), 3084 community pharmacies (CP), 139 public general hospitals (GHs) and 990 public primary health clinics (PHC). The health care facilities were found to be highly dense in urban areas than in the rural ones. There were six districts that had no CP, 2 had no GPC, and 11 did not have both. The overall ratio of GPC, CP, GH, and PHC to the population was 1:4228, 1:10,200, 1:223,619 and 1:31,397, respectively. Should the coverage for minor ailment services in public health care clinics be extended to community pharmacies, the ratio of facilities to population for each district would be better with 1:4000–8000. Conclusions The distribution of health care facilities for minor ailment management in Malaysia is relatively good. However, if the scheme for minor ailments were available to community pharmacies, then the patients’ access to minor ailments services would be further improved.

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Schizophrenia is a chronic mental disorder with marked symptoms of hallucination, delusion, and impaired cognitive behaviors. Although multidimensional factors have been associated with the development of schizophrenia, the principal cause of the disorder remains debatable. Microbiome involvement in the etiology of schizophrenia has been widely researched due to the advancement in sequencing technologies. This review describes the contribution of the gut microbiome in the development of schizophrenia that is facilitated by the gut-brain axis. The gut microbiota is connected to the gut-brain axis via several pathways and mechanisms, that are discussed in this review. The role of the oral microbiota, probiotics and prebiotics in shaping the gut microbiota are also highlighted. Lastly, future perspectives for microbiome research in schizophrenia are addressed.

Background: The involvement of pharmacists in diabetes education and management has been shown to improve patient outcomes worldwide. The pharmacist-managed Diabetes Medication Therapy Adherence Clinic (DMTAC) has been introduced across public healthcare settings in Malaysia to enhance patient adherence to treatment. Objective: This study was designed to assess the effectiveness of the DMTAC in optimizing the glycemic control of diabetic patients, and to subsequently identify the relationship between the number of follow-up visits and the glycemic control. Method: This was a retrospective cohort study performed in the department of Pharmacy, Sultan Abdul Halim Hospital, Kedah, Malaysia. All the patients, who had type 2 diabetes mellitus, made at least four visits to the pharmacist-managed DMTAC during May 2014 and April 2016, and had their HbA1c levels tested once each before enrolled in the DMTAC and within the same month of the last visit, were included. Percentage of patients achieving the targeted HbA1c level of 7.5% or below, and factors associated with the achievement of the targeted HbA1c level were recorded. Results: Only 21% of patients managed to achieve the targeted HbA1c level. Higher baseline HbA1c (OR: 2.34; 95% CI: 1.14, 4.79) and FPG (OR: 1.41; 95% CI: 1.02, 1.95) levels were more likely to lead to a non-optimized HbA1c level. Conclusion: Despite the effectiveness of the DMTAC in improving the glycemic control, majority of the patients did not achieve targeted level. Number of visits to the DMTAC is not a determinant of the targeted outcome and should not be used as discharging criteria in DMTAC.

Orofacial odontogenic infection, although arises from dental origin, can extend into the facial spaces and lead to debilitating complications. This study analysed the clinical pattern and management of orofacial odontogenic infection in a tertiary hospital namely Hospital Raja Permaisuri Bainun in Perak, Malaysia. We investigated any associations between socio-demographic factors, diabetic, comorbidities, smoking, pregnancy, antibiotic resistance, number and type of space infected towards prolonged hospital stay. All adult patients with orofacial odontogenic infections treated by Department of Oral and Maxillofacial Surgery from 2014 to 2018 were included. Clinical patterns were evaluated. Statistical analysis was performed to measure various variables towards prolonged hospital stay. A total of 154 patients (78 male, 76 female) were included in this study with mean age of 37.95 ± 14.9 years. Key factors of orofacial odontogenic infection requiring admissions were swelling, pain, trismus, odynophagia, reduced oral intake, raised floor of mouth and dyspnea. Among inpatients, three factors were significantly associated with prolonged hospital stay, namely antibiotic resistance, multiple space and secondary space infection. Local prevalence data was reported. Pus culture and sensitivity tests were recommended for all inpatients with multiple space and secondary space involvement, in order to rule out antibiotic resistance and to improve recovery rate.

aims to analyze the demographics and treatment outcomes of unilateral ZMC fractures, treated nonsurgically or surgically. Methods: This 5-year nonrandomized prospective study had included 65 cases of unilateral ZMC fractures from October 2014 until December 2019. Patients were treated and divided into nonsurgical and surgically treated group. Treatment outcomes in terms of step deformities, malar depression, diplopia, infraorbital hypoaesthesia, and mouth opening were evaluated up to six months post-trauma/intervention. Results: Road traffic accident (96.9%) was the main cause, with predominant male involvement (80%) and median age of 28 years. Significant improvements (P < 0.05) were observed for step deformities and malar depression among the surgically treated group at postoperative day 1 and week 1. Throughout the six months review, infraorbital hypoesthesia and diplopia showed no significant differences between both groups, (P > 0.05). Besides, all patients showed significant mouth opening improvement (P < 0.05) over six months period. Conclusion:The authors found that infraorbital hypoaesthesia and limited of mouth opening should not be the absolute indications for surgical treatment of ZMC fractures. Nonsurgical treatment that included early jaw exercise and symptomatic treatment had potential value for satisfactory functional gain.