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.
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.
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.
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