DESIGN: A thematic content analysis of OMERACT internal documents, publications and conference proceedings, followed by a responsive evaluation including 32 qualitative semistructured interviews.
SETTING: The international, biannual research conference OMERACT 10 (Malaysia, 2010).
PARTICIPANTS: Senior researchers (n=10), junior researchers (n=2), representatives of the pharmaceutical industry and regulators (n=2), conference staff (n=2), new patient delegates (n=8) and experienced patient delegates (n=8).
RESULTS: The role of patients evolved over 10 years from a single patient focus group to full participation in all areas of the meeting and inclusion in research group meetings between conferences. Five main categories of impact emerged: widening the research agenda; including patient relevant outcomes in core sets; enhancing patient reported instruments; changing the culture of OMERACT and consequences outside OMERACT. Patient participants identified previously neglected outcome domains such as fatigue, sleep disturbances and flares which prompted collaborative working on new programmes of research. Specific benefits and challenges for patients and professionals were identified, such as personal fulfilment, widening of research interests, difficulties in establishing equal partnerships and concerns about loss of research rigour.
CONCLUSIONS: Including patients as partners in OMERACT conferences has widened its focus and adjusted the way of working. It has resulted in new developments in the research agenda and the use of more patient-relevant outcomes in clinical trials. These collaborations have influenced perceptions and beliefs among many patients and researchers, and led to wider patient involvement as partners in research.
METHODS AND ANALYSIS: A serial cross-sectional design will be combined with a two-point in time longitudinal design to measure the levels of stigma among healthcare students from each year of undergraduate and graduate courses in Malaysia and Australia. In the absence of suitable measures, we will carry out a sequential mixed methods design to develop such a tool. The questionnaire data will be analysed using mixed effects linear models to manage the repeated measures.
ETHICS AND DISSEMINATION: We have received ethical approval from the Monash MBBS executive committee as well as the Monash University Human Research Ethics Committee. We will keep the data in a locked filing cabinet in the Monash University (Sunway campus) premises for 5 years, after which the information will be shredded and disposed of in secure bins, and digital recordings will be erased in accordance with Monash University's regulations. Only the principal investigator and the researcher will have access to the filing cabinet. We aim to present and publish the results of this study in national and international conferences and peer-reviewed journals, respectively.
DESIGN: Cross-sectional study.
SETTING: This study is part of a larger national study on the perception of the Malaysian public healthcare professionals on FMSs.
PARTICIPANTS: PHCPs from three categories of health facilities, namely hospitals, health clinics and health offices.
MAIN OUTCOME MEASURES: Qualitative analysis of written comments of respondents' expectation of FMSs.
RESULTS: The participants' response rate was 58% (780/1345) with an almost equal proportion from each public healthcare facility. We identified 21 subthemes for the 623 expectation comments. The six emerging themes are (1) need for more FMSs, (2) clinical roles and functions of FMSs, (3) administrative roles of FMSs, (4) contribution to community and public health, (5) attributes improvement and (6) research and audits. FMSs were expected to give attention to clinical duty. Delivering this responsibility with competence included having the latest medical knowledge in their own and others' medical disciplines, practising evidence-based medicine in prehospital and posthospital care, better supervision of staff and doctors under their care, fostering effective teamwork, communicating more often with hospital specialists and making appropriate referral. Expectations ranged from definite and strong for more FMSs at the health clinics to low expectation for FMSs' involvement in research; to mal-expectation on FMSs' involvement in community and public health programmes.
CONCLUSIONS: There were some remarkable differences in expectations on FMSs from the three different PHCPs. These ranged from being clinically competent and administratively available for patients and staff at the health clinics, to mal-expectations on FMSs to engage in public health affairs. Relevant parties, including FMSs themselves, could take appropriate self-improvement initiatives to enhance public practice of family medicine and patient care.
TRIAL REGISTRATION NUMBER NMRR ID: 08-12-1167.
SETTING: A tertiary medical centre in Kuala Lumpur, Malaysia.
PARTICIPANTS: A total of 219 patients (range 23-80 years) who had received phosphodiesterase type-5 (PDE-5) inhibitors as ED treatment were evaluated.
INCLUSION CRITERIA: Adult patients aged ≥18 years, diagnosed with ED, and prescribed with sildenafil, tadalafil or vardenafil.
EXCLUSION CRITERIA: Patients diagnosed with ED but who did not receive any PDE-5 inhibitor, or those with missing data.
PRIMARY AND SECONDARY OUTCOME MEASURES: Factors associated with demographic and clinical characteristics as well as drug selection were assessed.
RESULTS: Ischaemic heart disease (p=0.025), benign prostatic hyperplasia (p<0.001), obesity (p=0.005), lower urinary tract symptoms (LUTS) (p=0.006) and α-blockers (p<0.001) were significantly associated with elderly patients with ED. Additionally, LUTS (p=0.038) and α-blockers (p=0.008) were significantly associated with the selection of PDE-5 inhibitor.
CONCLUSIONS: These data showed that elderly patients with ED were significantly associated with comorbidities and α-blockers, whereas LUTS and α blockers were associated with drug selection.
METHODS AND ANALYSIS: ACT KNOW, the first randomised controlled trial ever performed in knowlesi malaria, is a two-arm open-label trial with enrolments over a 2-year period at three district sites in Sabah, powered to show a difference in proportion of patients negative for malaria by microscopy at 24 h between treatment arms (clinicaltrials.gov #NCT01708876). Enrolments started in December 2012, with completion expected by September 2014. A total sample size of 228 is required to give 90% power (α 0.05) to determine the primary end point using intention-to-treat analysis. Secondary end points include parasite clearance time, rates of recurrent infection/treatment failure to day 42, gametocyte carriage throughout follow-up and rates of anaemia at day 28, as determined by survival analysis.
ETHICS AND DISSEMINATION: This study has been approved by relevant institutional ethics committees in Malaysia and Australia. Results will be disseminated to inform knowlesi malaria treatment policy in this region through peer-reviewed publications and academic presentations.
TRIAL REGISTRATION NUMBER: NCT01708876.
METHODS AND ANALYSIS: A population-based case-control study will be conducted over a 2-year period at two adjacent districts in north-west Sabah, Malaysia. Confirmed malaria cases presenting to the district hospital sites meeting relevant inclusion criteria will be requested to enrol. Three community controls matched to the same village as the case will be selected randomly. Study procedures will include blood sampling and administration of household and individual questionnaires to evaluate potential exposure risks associated with acquisition of P. knowlesi malaria. Secondary outcomes will include differences in exposure variables between P. knowlesi and other Plasmodium spp, risk of severe P. knowlesi malaria, and evaluation of P. knowlesi case clustering. Primary analysis will be per protocol, with adjusted ORs for exposure risks between cases and controls calculated using conditional multiple logistic regression models.
ETHICS: This study has been approved by the human research ethics committees of Malaysia, the Menzies School of Health Research, Australia, and the London School of Hygiene and Tropical Medicine, UK.
SETTING: Cohort study.
PARTICIPANTS: Twelve biologically unrelated Malaysian-Chinese patients with congenital hypothyroidism were recruited in this study. All patients showed high thyrotropin and low free thyroxine levels at the time of diagnosis with proven presence of a thyroid gland.
PRIMARY OUTCOME MEASURE: Screening of the c.2268dup mutation in the TPO gene in all patients was carried out using a PCR-direct DNA sequencing method.
SECONDARY OUTCOME MEASURE: Further screening for mutations in other exonic regions of the TPO gene was carried out if the patient was a carrier of the c.2268dup mutation.
RESULTS: The c.2268dup mutation was detected in 4 of the 12 patients. Apart from the c.2268dup and a previously documented mutation (c.2647C>T), two novel TPO alterations, c.670_672del and c.1186C>T, were also detected in our patients. In silico analyses predicted that the novel alterations affect the structure/function of the TPO protein.
CONCLUSIONS: The c.2268dup mutation was detected in approximately one-third of the Malaysian-Chinese patients with thyroid dyshormonogenesis. The detection of the novel c.670_672del and c.1186C>T alterations expand the mutation spectrum of TPO associated with thyroid dyshormonogenesis.
SETTING: Haematology Lab, Department of Biomedical Science, University of Malaya.
PARTICIPANTS: Eight couples characterised as β-thalassaemia carriers where both partners posed the same β-globin gene mutations at CD41/42, IVS1-5 and IVS2-654, were recruited in this study.
OUTCOME MEASURES: Genotyping was performed by allele specific-PCR and the locations of SNPs were identified after sequencing alignment.
RESULTS: Genotype analysis revealed that at least one paternal SNP was present for each of the couples. Amplification on free-circulating DNA revealed that the paternal mutant allele of SNP was present in three fcDNA. Thus, the fetuses may be β-thalassaemia carriers or β-thalassaemia major. Paternal wild-type alleles of SNP were present in the remaining five fcDNA samples, thus indicating that the fetal genotypes would not be homozygous mutants.
CONCLUSIONS: This preliminary research demonstrates that paternal allele of SNP can be used as a non-invasive prenatal diagnosis approach for at-risk couples to determine the β-thalassaemia status of the fetus.
DESIGN: AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.
SETTING: Acute stroke units at 44 hospitals in 8 countries.
PARTICIPANTS: The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.
MODEL: We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.
RESULTS: The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).
CONCLUSIONS: A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.
TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).