Displaying publications 121 - 140 of 243 in total

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  1. Azzopardi M, Thomas R, Muruganandan S, Lam DC, Garske LA, Kwan BC, et al.
    BMJ Open, 2016 07 05;6(7):e011480.
    PMID: 27381209 DOI: 10.1136/bmjopen-2016-011480
    INTRODUCTION: Malignant pleural effusions (MPEs) can complicate most cancers, causing dyspnoea and impairing quality of life (QoL). Indwelling pleural catheters (IPCs) are a novel management approach allowing ambulatory fluid drainage and are increasingly used as an alternative to pleurodesis. IPC drainage approaches vary greatly between centres. Some advocate aggressive (usually daily) removal of fluid to provide best symptom control and chance of spontaneous pleurodesis. Daily drainages however demand considerably more resources and may increase risks of complications. Others believe that MPE care is palliative and drainage should be performed only when patients become symptomatic (often weekly to monthly). Identifying the best drainage approach will optimise patient care and healthcare resource utilisation.

    METHODS AND ANALYSIS: A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5% significance, 90% power) assuming a common between-group SD of 18.9 mm and a 10% lost to follow-up rate.

    ETHICS AND DISSEMINATION: The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings.

    TRIAL REGISTRATION NUMBER: ACTRN12615000963527; Pre-results.

  2. Sung CW, Chen CH, Fan CY, Chang JH, Hung CC, Fu CM, et al.
    BMJ Open, 2021 07 28;11(7):e052184.
    PMID: 34321309 DOI: 10.1136/bmjopen-2021-052184
    OBJECTIVES: During a pandemic, healthcare providers experience increased mental and physical burden. Burnout can lead to treatment errors, patient mortality, increased suicidal ideation and substance abuse as well as medical malpractice suits among medical staff. This study aimed to investigate the occurrence of burnout, acute stress disorder, anxiety disorder and depressive disorder among healthcare providers at the third month of the COVID-19 pandemic.

    DESIGN: A cross-sectional facility-based survey.

    SETTING: Hospitals around the country with different levels of care.

    PARTICIPANTS: A total of 1795 respondents, including 360 men and 1435 women who participated in the survey.

    PRIMARY OUTCOME MEASURES: Burnout was assessed using the Physician Work Life Study. A score of ≥3 implied burnout.

    RESULTS: Of the 1795 respondents, 723 (40.3%) reported burnout, and 669 (37.3%) cared for patients with COVID-19. Anxiety levels were mild in 185 (10.3%) respondents, moderate in 209 (11.6%) and severe in 1401 (78.1%). The mean Center for Epidemiologic Studies Depression Scale-10 score was 9.5±6.3, and 817 (45.5%) respondents were classified as having depression. Factors associated with burnout were working in acute and critical care (ACC) divisions (adjusted OR (aOR)=1.84, 95% CI 1.20 to 3.39, p=0.019), caring for patients with COVID-19 (aOR=3.90, 95% CI 1.14 to 13.37, p=0.031) and having depressive disorder (aOR=9.44, 95% CI 7.44 to 11.97, p<0.001).

    CONCLUSIONS: Physicians and nurses are vulnerable to burnout during a pandemic, especially those working in ACC divisions. Anxiety disorder, depressive disorder and care of patients with COVID-19 may be factors that influence the occurrence of burnout among healthcare providers.

  3. Kua CH, Mak VS, Lee SWH
    BMJ Open, 2019 10 11;9(10):e030106.
    PMID: 31604786 DOI: 10.1136/bmjopen-2019-030106
    OBJECTIVE: To examine the determinants of deprescribing among health professionals in nursing homes, focusing on knowledge, practice and attitude.

    DESIGN: This was a qualitative study comprising semi-structured face-to-face interviews guided by 10 open-ended questions. Interviews were conducted until data saturation was achieved and no new ideas were formed. The interviews were audio-recorded, transcribed verbatim and analysed for themes. To derive themes, we employed directed content analysis of transcript data. Coding was completed using a combination of open, axial and selective coding.

    SETTING: Four nursing homes in Singapore.

    PARTICIPANTS: The study involved 17 participants (comprising 4 doctors, 4 pharmacists and 9 nurses).

    RESULTS: Two key themes were identified, enablers and challenges. These were enablers and challenges faced by doctors, pharmacists and nurses towards deprescribing. The identified subthemes for enablers of deprescribing were: (1) awareness of medications that are unnecessary or could be targeted for deprescribing; (2) improving quality of life for patients with limited life expectancy; (3) improving communication between doctors, pharmacists and nurses; (4) systematic deprescribing practice and educational tools and (5) acknowledgement of possible benefits of deprescribing. The identified subthemes for challenges of deprescribing were: (1) symptoms not acknowledged as possibly drug-related; (2) lack of knowledge in patient's and family members' preferences; (3) lack of coordination between health professionals in hospitals and nursing homes and (4) limited tools for deprescribing. The development of a local guideline, mentoring nurses, case discussions, better shared decision-making and improving multidisciplinary communication, may help to support the process of deprescribing.

    CONCLUSION: In conclusion, this study highlighted that deprescribing in the nursing homes is perceived by health professionals to be challenging and future research could assess how routine case studies, mentoring and better multidisciplinary communication could improve deprescribing knowledge and process in the nursing homes.

  4. Lee JY, Chan CKY, Chua SS, Paraidathathu T, Lee KK, Tan CSS, et al.
    BMJ Open, 2019 Oct 22;9(10):e026575.
    PMID: 31640990 DOI: 10.1136/bmjopen-2018-026575
    OBJECTIVE: Telemedicine has been promoted as an economical and effective way to enhance patient care, but its acceptance among patients in low-income and middle-income countries is poorly understood. This study is aimed to explore the experiences and perspectives of people with type 2 diabetes mellitus that used telemedicine to manage their condition.

    DESIGN: In-depth and focus group interviews were conducted with participants who have engaged in telemedicine. Questions included were participants' perception on the programme being used, satisfaction as well as engagement with the telemedicine programme. All interviews and focus groups were audio-recorded and transcribed verbatim. Data were analysed using a thematic approach.

    PARTICIPANTS AND SETTING: People with type 2 diabetes (n=48) who participated in a randomised controlled study which examined the use of telemedicine for diabetes management were recruited from 11 primary care clinics located within the Klang Valley.

    RESULTS: Twelve focus groups and two in-depth interviews were conducted. Four themes emerged from the analysis: (1) generational difference; (2) independence and convenience, (3) sharing of health data and privacy and (4) concerns and challenges. The main obstacles found in patients using the telemedicine systems were related to internet connectivity and difficulties experienced with system interface. Cost was also another significant concern raised by participants. Participants in this study were primarily positive about the benefits of telemedicine, including its ability to provide real-time data and disease monitoring and the reduction in clinic visits.

    CONCLUSION: Despite the potential benefits of telemedicine in the long-term care of diabetes, there are several perceived barriers that may limit the effectiveness of this technology. As such, collaboration between educators, healthcare providers, telecommunication service providers and patients are required to stimulate the adoption and the use of telemedicine.NCT0246680.

  5. Chong ET, Lee CC, Chua KH, Chuah JA, Lee PC
    BMJ Open, 2014;4(1):e004109.
    PMID: 24394801 DOI: 10.1136/bmjopen-2013-004109
    Our study aimed to investigate the association of CYP2E1 C-1019T RsaI and T7678A DraI polymorphisms and factors such as age, gender and ethnicity to the risk of gastrointestinal cancer (GIC) in Malaysians.
  6. Zakaria N, Zakaria NH, Bin Abdul Rassip MNA, Lee KY
    BMJ Open, 2022 Oct 10;12(10):e064687.
    PMID: 36216421 DOI: 10.1136/bmjopen-2022-064687
    OBJECTIVE: This national-level study aimed to determine the prevalence and risk factors of burnout, as well as the coping strategies among nurses in the Ministry of Health (MOH) Malaysia.

    DESIGN: Using a complex sampling design, a two-stage stratified cluster sampling was performed to recruit MOH nurses between August and November 2019.

    SETTING AND PARTICIPANTS: A total of 2428 nurses from 32 hospitals and 28 district health offices answered the questionnaires based on Maslach Burnout Inventory for Human Services and Brief COPE. Complex sampling analysis was applied.

    OUTCOME MEASURES: The outcome of interest was the prevalence of burnout and its three domains of emotional exhaustion (EE), depersonalisation (DP) and low personal accomplishment. ORs using 95% CIs were calculated. Significant factors at the univariate level were entered into the multivariate logistic regression to identify independent predictors of burnout.

    RESULTS: One in four (24.4%) nurses experienced burnout. Younger, single, and childless nurses had a higher prevalence of burnout. Shift working nurses were 1.6 times more likely to develop burnout. Those who performed >6 night shifts per month were 1.5 times more predisposed to burnout (95% CI 1.01 to 2.36; p<0.05). While encountering traumatic events at work led to 4.2 times (95% CI 2.31, 7.63; p<0.05) higher risk of burnout, those who received post-traumatic psychological support were better protected. The use of dysfunctional coping strategies was detrimental as it was positively correlated with EE and DP.

    CONCLUSION: Addressing modifiable stressors of burnout at individual and institutional levels identified in this study can be potentially beneficial in reducing burnout and its undesirable effects among nurses. Interventions that promote positive coping strategies should be implemented. Organisational-driven efforts must target the improvement of work schedules for nurses and the establishment of a structured debriefing service for post-trauma counselling.

  7. Ross B, Penkunas MJ, Maher D, Certain E, Launois P
    BMJ Open, 2022 May 03;12(5):e054719.
    PMID: 35504633 DOI: 10.1136/bmjopen-2021-054719
    INTRODUCTION: An implementation research (IR) massive open online course (MOOC) was developed by the Special Programme for Research and Training in Tropical Diseases, to address the scarcity of training in low-income and middle-income countries in the field of IR. The Kirkpatrick model was used to evaluate the IR MOOC as it is widely applied for evaluation of training and educational programmes. The Kirkpatrick model evaluates training programmes on four levels: reaction, learning, behaviour and results. This paper addresses the impact of the IR MOOC on participants' professional practice.

    METHODS: Findings are based on analysis of survey and interview data collected 1.5-2 years after the conclusion of the two 2018 IR MOOC offerings. Of the 3858 MOC participants, 748 responded to the anonymous online survey and seven of these respondents were interviewed. All data are self-reported.

    RESULTS: The IR MOOC was successful in enhancing the professional practice of participants and for their organisations. Over 40% reported modifying or implementing changes in their professional work. Respondents reported that participation in the MOOC had improved their ability to conduct IR, enhanced their professional profiles and increased their opportunities for collaboration, research and job promotion. Respondents stated that the MOOC had improved their work quality and productivity, and allowed them to contribute to research, initiate and develop professional collaborations and train others in IR. Respondents reported an increase in applying for grants and scholarships and presenting and publishing work on IR after participating in the MOOC. Barriers applying the knowledge gained from the IR MOOC were experienced, for example, due to a lack of funding and lack of support from colleagues, managers and organisations.

    CONCLUSION: Participants perceived that the IR MOOC was successful in its aims of delivering medium-term and long-term results in relation to their own and their organisations' professional outcomes.

  8. Keijzers G, Kelly AM, Cullen L, Klim S, Graham CA, Craig S, et al.
    BMJ Open, 2017 02 28;7(2):e013812.
    PMID: 28246137 DOI: 10.1136/bmjopen-2016-013812
    OBJECTIVES: To describe demographic features, assessment, management and outcomes of patients who were diagnosed with heart failure after presenting to an emergency department (ED) with a principal symptom of dyspnoea.

    DESIGN: Planned substudy of the prospective, descriptive cohort study: Asia, Australia and New Zealand Dyspnoea in Emergency Departments (AANZDEM).

    SETTING: 46 EDs in Australia, New Zealand, Singapore, Hong Kong and Malaysia collected data over 3 72-hour periods in May, August and October 2014.

    PARTICIPANTS: Patients with an ED diagnosis of heart failure.

    OUTCOME MEASURES: Outcomes included patient epidemiology, investigations ordered, treatment modalities used and patient outcomes (hospital length of stay (LOS) and mortality).

    RESULTS: 455 (14.9%) of the 3044 patients had an ED diagnosis of heart failure. Median age was 79 years, half were male and 62% arrived via ambulance. 392 (86%) patients were admitted to hospital. ED diagnosis was concordant with hospital discharge diagnosis in 81% of cases. Median hospital LOS was 6 days (IQR 4-9) and in-hospital mortality was 5.1%. Natriuretic peptide levels were ordered in 19%, with lung ultrasound (<1%) and echocardiography (2%) uncommonly performed. Treatment modalities included non-invasive ventilation (12%), diuretics (73%), nitrates (25%), antibiotics (16%), inhaled β-agonists (13%) and corticosteroids (6%).

    CONCLUSIONS: In the Asia Pacific region, heart failure is a common diagnosis among patients presenting to the ED with a principal symptom of dyspnoea. Admission rates were high and ED diagnostic accuracy was good. Despite the seemingly suboptimal adherence to investigation and treatment guidelines, patient outcomes were favourable compared with other registries.

  9. Aggarwal A, Court LE, Hoskin P, Jacques I, Kroiss M, Laskar S, et al.
    BMJ Open, 2023 Dec 07;13(12):e077253.
    PMID: 38149419 DOI: 10.1136/bmjopen-2023-077253
    INTRODUCTION: Fifty per cent of patients with cancer require radiotherapy during their disease course, however, only 10%-40% of patients in low-income and middle-income countries (LMICs) have access to it. A shortfall in specialised workforce has been identified as the most significant barrier to expanding radiotherapy capacity. Artificial intelligence (AI)-based software has been developed to automate both the delineation of anatomical target structures and the definition of the position, size and shape of the radiation beams. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy.

    METHODS: ARCHERY is a non-randomised prospective study to evaluate the quality and economic impact of AI-based automated radiotherapy treatment planning for cervical, head and neck, and prostate cancers, which are endemic in LMICs, and for which radiotherapy is the primary curative treatment modality. The sample size of 990 patients (330 for each cancer type) has been calculated based on an estimated 95% treatment plan acceptability rate. Time and cost savings will be analysed as secondary outcome measures using the time-driven activity-based costing model. The 48-month study will take place in six public sector cancer hospitals in India (n=2), Jordan (n=1), Malaysia (n=1) and South Africa (n=2) to support implementation of the software in LMICs.

    ETHICS AND DISSEMINATION: The study has received ethical approval from University College London (UCL) and each of the six study sites. If the study objectives are met, the AI-based software will be offered as a not-for-profit web service to public sector state hospitals in LMICs to support expansion of high quality radiotherapy capacity, improving access to and affordability of this key modality of cancer cure and control. Public and policy engagement plans will involve patients as key partners.

  10. Mohamed-Yassin MS, Baharudin N, Abdul-Razak S, Ramli AS, Lai NM
    BMJ Open, 2021 Dec 03;11(12):e049662.
    PMID: 34862282 DOI: 10.1136/bmjopen-2021-049662
    INTRODUCTION: Dyslipidaemia is one of the established risk factors for cardiovascular disease. Evidence from large-scale trials showed that effective treatment of dyslipidaemia can reduce all-cause and coronary mortality. To date, there is no published systematic review on the worldwide prevalence of dyslipidaemia in adults. We propose to perform a systematic review on the global prevalence of dyslipidaemia in adults 18 years and older.

    METHODS AND ANALYSIS: We will identify observational studies through comprehensive literature searches. We will search: MEDLINE, Cochrane Central Register of Controlled Trials for published studies and trial registries including the WHO International Trial Registry Platform and ClinicalTrials.gov. Two reviewers will independently screen the titles and abstracts, attain full text of eligible articles, extract data, and appraise the quality and bias of the included studies. Disagreement among the authors will be resolved by discussion leading to a consensus. Next, we will perform a narrative synthesis of the study results. Study heterogeneity will be assessed using I2 statistics. If I2 is high (≥75%), and plausible heterogeneity contributors are found, we will divide the studies into appropriate subgroups for pooling of results or assess the association of plausible covariates and the prevalence estimates using meta-regression. If I2<75%, we will undertake meta-analysis using the random-effects model and transform all prevalence estimates using the Freeman-Tukey transformation for pooling, to obtain a synthesised point estimate of prevalence with its 95% confidence. We will then back-transform the point estimate, and report our results using the back-transformed figures.

    ETHICS AND DISSEMINATION: Ethics approval is not a requirement as this study is based on available published data. Results of this systematic review will be presented at conferences, shared with relevant health authorities, and published in a peer-reviewed journal. These results may help quantify the magnitude of dyslipidaemia globally, and guide preventative and therapeutic interventions.

    PROSPERO REGISTRATION NUMBER: CRD42020200281.

  11. Mei Hsien CC, Wan Azman WA, Md Yusof M, Ho GF, Krupat E
    BMJ Open, 2012;2(5).
    PMID: 23035016 DOI: 10.1136/bmjopen-2012-001799
    Psychological distress is common in patients with cancer. We need a rapid means of screening for and identifying depression and anxiety in patients with cancer. The present study evaluates the potential of the Eastern Cooperative Oncology Group (ECOG) performance status (PS) scoring as a brief screening tool to assess psychological distress in routine cancer care. The ECOG PS is widely used by oncologists and the WHO, as a standardised measure to assess general well-being in patients with cancer and quality of life in cancer trials. We examine the discrepancy between patient-rated and oncologist-rated PS scores on the ECOG in a comparative assessment against the Hospital Anxiety and Depression Scale (HADS).
  12. Omar R, Anan NS, Azri IA, Majumder C, Knight VF
    BMJ Open, 2022 Jan 31;12(1):e048965.
    PMID: 35105614 DOI: 10.1136/bmjopen-2021-048965
    OBJECTIVE: The aim of this study is to determine the characteristics of eye injuries, medical costs and return-to-work status among industrial workers to provide better vision rehabilitative services.

    SETTING: Nationwide data from the Social Security Organisation (SOCSO) of Malaysia.

    PARTICIPANTS: A stratified random sample of workers registered with the SOCSO of Malaysia with documentation of eye injury.

    PRIMARY AND SECONDARY OUTCOME MEASURES: Characteristics of eye injuries and medical costs related to eye injury (primary) and return-to-work status (secondary).

    RESULTS: A total of 884 from 8861 case files workplace accidents involving eye injury registered with Social Security Services (SOCSO) were identified. The mean age was 35±10 years and the highest incidence of work-related eye injury occurred in the age group 30-39 years and among Malay ethnics. Males are affected more than females' workers. The highest cause of eye injury was the impact from a moving object excluding falling objects (89.2%) and anterior segment injuries occurred more than posterior segment injuries. The total direct and Indirect medical cost was RM1 108 098.00 (US$316 599.40) and RM4 150 140.00 (US$1 185 754.20) for 884 cases.

    CONCLUSION: The majority of workers suffered from the low level of eye injury. A significant relationship was found between the severity of eye injury and employee work status. The indirect cost of medical and vision rehabilitation was higher than the direct cost. Awareness and vision rehabilitation programmes at the workplace need to be addressed for better prevention and rehabilitative service.

  13. de Wit M, Abma T, Koelewijn-van Loon M, Collins S, Kirwan J
    BMJ Open, 2013 May 09;3(5).
    PMID: 23667160 DOI: 10.1136/bmjopen-2012-002241
    OBJECTIVE: To assess the inclusion of patients as international research partners in Outcome Measures in Rheumatology (OMERACT) conferences and how this has influenced the scope and conduct of outcomes research in rheumatology.

    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.

  14. Kim YE
    BMJ Open, 2021 04 14;11(4):e045070.
    PMID: 33853801 DOI: 10.1136/bmjopen-2020-045070
    OBJECTIVES: Childhood vaccination coverage in Nagaland has lagged almost all states in India for more than two decades. This study aims to find drivers and barriers of childhood vaccination in Nagaland from the perspective of demand, supply and local health governance.

    DESIGN: A cross-sectional study was designed using a survey conducted by the Directorate of Health and Family in 2015.

    SETTING: Households, community-based health centres and health committees were surveyed.

    PARTICIPANTS: 285 children aged under 2 years with vaccination cards and data on households, health centres and health committees were included.

    OUTCOMES: Variables indicating whether a child received each of bacillus calmette-guérin (BCG), diphtheria-tetanus-pertussis (DTP3), oral polio (OPV3) and measles vaccination and all of them were outcome variables. Associated factors were identified using multilevel logistic regressions.

    RESULTS: Antenatal care at least three times was significantly associated with BCG, DTP3, OPV3 and full vaccination with adjusted ORs ranging from 2.4 (95% CI 1.1 to 5.1) to 3.3 (1.1 to 9.9). The availability of bus to health centre was slightly significant for BCG and OPV3 with the adjusted ORs of 2.0 (0.9 to 4.5) and 2.1 (0.9 to 4.8), respectively. Health committees' budget provision to health centres was significant for OPV3 and full vaccination with the respective adjusted ORs of 15.7 (1.0 to 234.1) and 15.9 (1.2 to 214.7), the wide 95% CIs of which were driven by a small sample size. Health committees' review of expenditure of health centres was significant for measles and full vaccination with the adjusted ORs of 4.0 (1.4 to 11.4) and 5.2 (1.4 to 19.4), respectively.

    CONCLUSION: This study suggests that enhancing the utilisation of antenatal care and providing reliable transportation between villages and health centres are required to improve childhood vaccination coverage. Also, the significant association of budget administration of health committees suggests that supporting local health committees for effective financial management is important.

  15. Chang WH, Kim TW, Kim HS, Hanapiah FA, Kim DH, Kim DY
    BMJ Open, 2023 Aug 11;13(8):e065298.
    PMID: 37567748 DOI: 10.1136/bmjopen-2022-065298
    INTRODUCTION: The purpose of this study is to determine the effect of overground gait training using an exoskeletal wearable robot (exoskeleton) on the recovery of ambulatory function in patients with subacute stroke. We also investigate the assistive effects of an exoskeleton on ambulatory function in patients with subacute stroke.

    METHODS AND ANALYSIS: This study is an international, multicentre, randomised controlled study at five institutions with a total of 150 patients with subacute stroke. Participants will be randomised into two groups (75 patients in the robot-assisted gait training (RAGT) group and 75 patients in the control group). The gait training will be performed with a total of 20 sessions (60 min/session); 5 sessions a week for 4 weeks. The RAGT group will receive 30 min of gait training using an exoskeleton (ANGEL LEGS M20, Angel Robotics) and 30 min of conventional gait training, while the control group will receive 60 min conventional gait training. In all the patients, the functional assessments such as ambulation, motor and balance will be evaluated before and after the intervention. Follow-up monitoring will be performed to verify whether the patient can walk without physical assistance for 3 months. The primary outcome is the improvement of the Functional Ambulatory Category after the gait training. The functional assessments will also be evaluated immediately after the last training session in the RAGT group to assess the assistive effects of an exoskeletal wearable robot. This trial will provide evidence on the effects of an exoskeleton to improve and assist ambulatory function in patients with subacute stroke.

    ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board of each hospital and conforms to the Declaration of Helsinki. The results will be disseminated through publication.

    TRIAL REGISTRATION NUMBER: Protocol was registered at ClinicalTrials.gov (NCT05157347) on 15 December 2021 and CRIS (KCT0006815) on 19 November 2021.

  16. Mallhi TH, Khan AH, Sarriff A, Adnan AS, Khan YH
    BMJ Open, 2017 Jul 10;7(7):e016805.
    PMID: 28698348 DOI: 10.1136/bmjopen-2017-016805
    OBJECTIVES: Dengue imposes substantial economic, societal and personal burden in terms of hospital stay, morbidity and mortality. Early identification of dengue cases with high propensity of increased hospital stay and death could be of value in isolating patients in need of early interventions. The current study was aimed to determine the significant factors associated with dengue-related prolonged hospitalisation and death.

    DESIGN: Cross-sectional retrospective study.

    SETTING: Tertiary care teaching hospital.

    PARTICIPANTS: Patients with confirmed dengue diagnosis were stratified into two categories on the basis of prolonged hospitalisation (≤3 days and >3 days) and mortality (fatal cases and non-fatal cases). Clinico-laboratory characteristics between these categories were compared by using appropriate statistical methods.

    RESULTS: Of 667 patients enrolled, 328 (49.2%) had prolonged hospitalisation. The mean hospital stay was 4.88±2.74 days. Multivariate analysis showed that dengue haemorrhagic fever (OR 2.3), elevated alkaline phosphatase (ALP) (OR 2.3), prolonged prothrombin time (PT) (OR 1.7), activated partial thromboplastin time (aPTT) (OR 1.9) and multiple-organ dysfunctions (OR 2.1) were independently associated with prolonged hospitalisation. Overall case fatality rate was 1.1%. Factors associated with dengue mortality were age >40 years (p=0.004), secondary infection (p=0.040), comorbidities (p<0.05), acute kidney injury (p<0.001), prolonged PT (p=0.022), multiple-organ dysfunctions (p<0.001), haematocrit >20% (p=0.001), rhabdomyolosis (p<0.001) and respiratory failure (p=0.007). Approximately half of the fatal cases in our study had prolonged hospital stay of greater than three days.

    CONCLUSIONS: The results underscore the high proportion of dengue patients with prolonged hospital stay. Early identification of factors relating to prolonged hospitalisation and death will have obvious advantages in terms of appropriate decisions about treatment and management in high dependency units.

    Study site: Hospital Universiti Sains Malaysia (HUSM), Kelantan
  17. Haseeb A, Winit-Watjana W, Bakhsh AR, Elrggal ME, Hadi MA, Mously AA, et al.
    BMJ Open, 2016 06 16;6(6):e011401.
    PMID: 27311911 DOI: 10.1136/bmjopen-2016-011401
    OBJECTIVES: To evaluate the effectiveness of a pharmacist-led educational intervention to reduce the use of high-risk abbreviations (HRAs) by healthcare professionals.

    DESIGN: Quasi-experimental study consisting of a single group before-and-after study design.

    SETTING: A public emergency hospital in Mecca, Saudi Arabia.

    PARTICIPANTS: 660 (preintervention) and then 498 (postintervention) handwritten physician orders, medication administration records (MRAs) and pharmacy dispensing sheets of 482 and 388 patients, respectively, from emergency wards, inpatient settings and the pharmacy department were reviewed.

    INTERVENTION: The intervention consisted of a series of interactive lectures delivered by an experienced clinical pharmacist to all hospital staff members and dissemination of educational tools (flash cards, printed list of HRAs, awareness posters) designed in line with the recommendations of the Institute for Safe Medical Practices and the US Food and Drug Administration. The duration of intervention was from April to May 2011.

    MAIN OUTCOME: Reduction in the incidence of HRAs use from the preintervention to postintervention study period.

    FINDINGS: The five most common abbreviations recorded prior to the interventions were 'IJ for injection' (28.6%), 'SC for subcutaneous' (17.4%), drug name and dose running together (9.7%), 'OD for once daily' (5.8%) and 'D/C for discharge' (4.3%). The incidence of the use of HRAs was highest in discharge prescriptions and dispensing records (72.7%) followed by prescriptions from in-patient wards (47.3%). After the intervention, the overall incidence of HRA was significantly reduced by 52% (ie, 53.6% vs 25.5%; p=0.001). In addition, there was a statistically significant reduction in the incidence of HRAs across all three settings: the pharmacy department (72.7% vs 39.3%), inpatient settings (47.3% vs 23.3%) and emergency wards (40.9% vs 10.7%).

    CONCLUSIONS: Pharmacist-led educational interventions can significantly reduce the use of HRAs by healthcare providers. Future research should investigate the long-term effectiveness of such educational interventions through a randomised controlled trial.

  18. Webair HH, Ismail TAT, Ismail SB, Khaffaji AJ
    BMJ Open, 2021 06 18;11(6):e044300.
    PMID: 34145008 DOI: 10.1136/bmjopen-2020-044300
    OBJECTIVE: The current study aims to define patient-centred infertility care (PCIC) from the perspective of Arab women with infertility.

    DESIGN: Semistructured in-depth telephone interviews.

    SETTING: Hospitals providing infertility care, Jeddah, Saudi Arabia.

    PARTICIPANTS: Arab women who received infertility treatment during the 6 months preceding the interview at any hospital in Jeddah, Saudi Arabia. Interviews were conducted with Arab women experiencing infertility from January 2017 to December 2018. A purposive sample of 14 women were included in the final analysis with maximum variation.

    RESULTS: Participants highlighted nine important PCIC dimensions. Of these, four were agreed on by all participants: accessibility, minimising cost, information and education, and staff attitudes and communication. The remaining five dimensions were staff competence, physical comfort, privacy, psychological and emotional support, and continuity and coordination of care. The concept of PCIC was related to three major contributors: participants' demographics, patient experience with infertility care and health-seeking behaviour.

    CONCLUSIONS: The current study provided nine PCIC dimensions and items, which can guide efforts to improve the quality of infertility care in Arab countries in two ways: first, by raising infertility care providers' awareness of their patients' needs, and second, by developing a validated tool based on the dimensions for measuring PCIC from Arab patients' perspective. Clear differences between the Arab and the European PCIC model were found. Our findings concluded that women continued to exhibit basic unmet needs.

  19. Samson KLI, Loh SP, Khor GL, Mohd Shariff Z, Yelland LN, Leemaqz S, et al.
    BMJ Open, 2020 02 05;10(2):e034598.
    PMID: 32029499 DOI: 10.1136/bmjopen-2019-034598
    INTRODUCTION: Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs). Because these birth defects occur early in pregnancy, before women may know they are pregnant, many countries have mandated the addition of folic acid to food staples. In countries where fortification is not possible, and weekly iron folic acid programmes exist to reduce anaemia, the WHO recommends that 2.8 mg (7×0.4 mg) folic acid be given instead of the current weekly practice of 0.4 mg. Currently, there is a lack of evidence to support if the 2.8 mg folic acid per week dose is sufficient to raise erythrocyte folate concentrations to a level associated with a reduced risk of a NTD-affected pregnancy. We aim to conduct a three-arm randomised controlled trial to determine the effect of weekly folic acid with iron on erythrocyte folate, a biomarker of NTD risk.

    METHODS AND ANALYSIS: We will recruit non-pregnant women (n=300; 18-45 years) from Selangor, Malaysia. Women will be randomised to receive either 2.8, 0.4 or 0.0 (placebo) mg folic acid with 60 mg iron weekly for 16 weeks, followed by a 4-week washout period. The primary outcome will be erythrocyte folate concentration at 16 weeks and the mean concentration will be compared between randomised treatment groups (intention-to-treat) using a linear regression model adjusting for the baseline measure.

    ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of British Columbia (H18-00768) and Universiti Putra Malaysia (JKEUPM-2018-255). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals.

    TRIAL REGISTRATION NUMBERS: ACTRN12619000818134 and NMRR-19-119-45736.

  20. Ooi CP, Yusof Khan AHK, Abdul Manaf R, Mustafa N, Sukor N, Williamson PR, et al.
    BMJ Open, 2021 Jul 28;11(7):e050231.
    PMID: 34321306 DOI: 10.1136/bmjopen-2021-050231
    INTRODUCTION: Thyroid dysfunctions (TD) are common medical conditions affecting all global populations. Improved healthcare leading to increasing survival rates and delayed diagnosis rendered significant burden of the disease in the increasing number of patients with TD with comorbid illnesses. Therefore, reducing the burden of TD and improving the quality of care are crucial. Existing poor-quality data that guide evidence-based decisions only provide a fragmented picture of clinical care. The different outcomes across studies assessing the effectiveness of treatments impede our ability to synthesise results for determining the most efficient treatments. This project aims to produce a core outcome set (COS), which embeds the multiple complex dimensions of routine clinical care for the effectiveness studies and clinical care of adult patients with TD.

    METHODS AND ANALYSIS: This mixed-method project has two phases. In phase 1, we will identify a list of patient-reported and clinical outcomes through qualitative research and systematic reviews. In phase 2, we will categorise the identified outcomes using the Core Outcome Measures in Effectiveness Trials taxonomy of core domains and the International Classification of Functioning, Disability and Health. We will develop questionnaires from the list of outcomes identified from each domain for the two-round online Delphi exercise, aiming to reach a consensus on the COS. The Delphi process will include patients, carers, researchers and healthcare participants. We will hold an online consensus meeting involving representatives of all key stakeholders to establish the final COS.

    ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia and the Research Ethics Committee, National University of Malaysia. This proposed COS in TD will improve the value of data, facilitate high-quality evidence synthesis and evidence-based decision-making. Furthermore, we will present the results to participants, in peer-reviewed academic journals and conferences.

    REGISTRATION DETAILS: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1371.

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