Displaying publications 1 - 20 of 34 in total

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  1. Skau JK, Nordin AB, Cheah JC, Ali R, Zainal R, Aris T, et al.
    Trials, 2016;17(1):215.
    PMID: 27117703 DOI: 10.1186/s13063-016-1345-x
    Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy.
  2. Inoue K, Chieh JTW, Yeh LC, Chiang SJ, Phrommintikul A, Suwanasom P, et al.
    Trials, 2022 Dec 07;23(1):986.
    PMID: 36476401 DOI: 10.1186/s13063-022-06907-4
    BACKGROUND: More than half of the world's population lives in Asia. With current life expectancies in Asian countries, the burden of cardiovascular disease is increasing exponentially. Overcrowding in the emergency departments (ED) has become a public health problem. Since 2015, the European Society of Cardiology recommends the use of a 0/1-h algorithm based on high-sensitivity cardiac troponin (hs-cTn) for rapid triage of patients with suspected non-ST elevation acute coronary syndrome (NSTE-ACS). However, these algorithms are currently not recommended by Asian guidelines due to the lack of suitable data.

    METHODS: The DROP-Asian ACS is a prospective, stepped wedge, cluster-randomized trial enrolling 4260 participants presenting with chest pain to the ED of 12 acute care hospitals in five Asian countries (UMIN; 000042461). Consecutive patients presenting with suspected acute coronary syndrome between July 2022 and Apr 2024 were included. Initially, all clusters will apply "usual care" according to local standard operating procedures including hs-cTnT but not the 0/1-h algorithm. The primary outcome is the incidence of major adverse cardiac events (MACE), the composite of all-cause death, myocardial infarction, unstable angina, or unplanned revascularization within 30 days. The difference in MACE (with one-sided 95% CI) was estimated to evaluate non-inferiority. The non-inferiority margin was prespecified at 1.5%. Secondary efficacy outcomes include costs for healthcare resources and duration of stay in ED.

    CONCLUSIONS: This study provides important evidence concerning the safety and efficacy of the 0/1-h algorithm in Asian countries and may help to reduce congestion of the ED as well as medical costs.

  3. Katiri R, Hall DA, Buggy N, Hogan N, Horobin A, van de Heyning P, et al.
    Trials, 2020 Mar 04;21(1):238.
    PMID: 32131880 DOI: 10.1186/s13063-020-4094-9
    BACKGROUND: Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and auditory implants. Benefits and harms of these interventions are documented inconsistently in the literature, using a variety of outcomes ranging from tests of speech perception to quality of life questionnaires. It is therefore difficult to compare interventions when rehabilitating SSD. The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study is an international initiative that aims to develop a minimum set of core outcomes for use in future trials of SSD interventions.

    METHODS/DESIGN: The CROSSSD study adopts an international two-round online modified Delphi survey followed by a stakeholder consensus meeting to identify a patient-centred core outcome domain set for SSD based on what is considered critical and important for assessing whether an intervention for SSD has worked.

    DISCUSSION: The resulting core outcome domain set will act as a minimum standard for reporting in future clinical trials and could have further applications in guiding the use of outcome measures in clinical practice. Standardisation will facilitate comparison of research findings.

  4. Katiri R, Hall DA, Buggy N, Hogan N, Horobin A, van de Heyning P, et al.
    Trials, 2020 03 17;21(1):272.
    PMID: 32183858 DOI: 10.1186/s13063-020-04240-2
    Following the publication of our article [1], the authors have notified us of a typo in the third bullet point of the Consensus Criteria section.
  5. Ting CY, Adruce SAZ, Hassali MA, Ting H, Lim CJ, Ting RS, et al.
    Trials, 2019 05 10;20(1):267.
    PMID: 31077233 DOI: 10.1186/s13063-019-3348-x
    After publication of the original article [1], the authors have notified us that there are changes to the primary outcome of the study, instrument, subject's inclusion criteria, the funding and acknowledgements. These changes were made during the recruitment of participants and after approved by the Medical Research and Ethics Committee (MREC), National Institutes of Health Malaysia, on 16th November 2018.
  6. Lee YL, Lim YMF, Law KB, Sivasampu S
    Trials, 2020 Sep 10;21(1):778.
    PMID: 32912297 DOI: 10.1186/s13063-020-04715-2
    An amendment to this paper has been published and can be accessed via the original article.
  7. Ting CY, Ahmad Zaidi Adruce S, Hassali MA, Ting H, Lim CJ, Ting RS, et al.
    Trials, 2018 Jun 05;19(1):310.
    PMID: 29871651 DOI: 10.1186/s13063-018-2649-9
    BACKGROUND: Amidst the high disease burden, non-adherence to medications among patients with type 2 diabetes mellitus (T2DM) has been reported to be common and devastating. Sarawak Pharmaceutical Services Division has formulated a pharmacist-led, multiple-theoretical-grounding, culturally sensitive and structured group-based program, namely "Know Your Medicine - Take if for Health" (MEDIHEALTH), to improve medication adherence among Malay patients with T2DM. However, to date, little is known about the effectiveness and sustainability of the Program.

    METHODS/DESIGN: This is a prospective, parallel-design, two-treatment-group randomized controlled trial to evaluate the effectiveness and sustainability of MEDIHEALTH in improving medication adherence. Malay patients who have underlying T2DM, who obtain medication therapy at Petra Jaya Health Clinic and Kota Samarahan Health Clinic, and who have a moderate to low adherence level (8-item Morisky Medication Adherence Scale, Malaysian specific, score <6) were randomly assigned to the treatment group (MEDIHEALTH) or the control group. The primary outcome of this study is medication adherence level at baseline and 1, 3, 6 and 12 months post-intervention. The secondary outcomes are attitude, subjective norms, perceived behavioural control, intention and knowledge related to medication adherence measured at baseline and 1, 6 and 12 months post-intervention. The effectiveness and sustainability of the Program will be triangulated by findings from semi-structured interviews with five selected participants conducted 1 month after the intervention and in-depth interviews with two main facilitators and two managerial officers in charge of the Program 12 months after the intervention. Statistical analyses of quantitative data were conducted using SPSS version 22 and Stata version 14. Thematic analysis for qualitative data were conducted with the assistance of ATLAS.ti 8.

    DISCUSSION: This study provides evidence on the effectiveness and sustainability of a structured group-based educational program that employs multiple theoretical grounding and a culturally sensitive approach in promoting medication adherence among Malays with underlying T2DM. Both the quantitative and qualitative findings of this study could assist in the future development of the Program.

    TRIAL REGISTRATION: National Medical Research Register, NMRR-17-925-35875 (IIR). Registered on 19 May 2017. ClinicalTrials.gov, NCT03228706 . Registered on 25 July 2017.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  8. Mohamad Safiai NI, Amir NA, Basri H, Inche Mat LN, Hoo FK, Yusof Khan AHK, et al.
    Trials, 2020 Nov 11;21(1):923.
    PMID: 33176870 DOI: 10.1186/s13063-020-04832-y
    BACKGROUND: This is a phase II randomised, double-blind, sham-controlled trial to evaluate the effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine amongst migraine subjects.

    METHODS: Subjects age 18 to 60 years will undergo a baseline evaluation to establish the diagnosis of migraine based on the International Classification of Headache Disorder 3rd Edition (ICHD-3). Those who fulfil the ICHD-3 criteria for episodic migraine and compliant to the headache diary during a month run-in period will be enrolled. A total of 76 subjects will be randomised to receive either transcranial magnetic stimulation or sham stimulation for 5 sessions within 2 weeks duration. Follow-up sessions will be conducted monthly for three consecutive months. Prior to treatment, subjects will be required to fill up questionnaires and undergo few procedures such as electroencephalography, transcranial Doppler ultrasound and biochemical analysis for serum serotonin, serum calcitonin gene-related peptide and serum beta-endorphin. These procedures will be repeated at month 3 after receiving the last treatment. The primary outcome measure of this study is the difference in mean monthly migraine days at baseline and at months 1, 2 and 3 after treatment sessions.

    DISCUSSION: Following evidence from previous studies showing restoration of dorsolateral prefrontal cortex (DLPFC) activation to almost normal level, the rTMS intervention will target left DLPFC in this study. An intermediate duration of treatment sessions is selected for this study. It is set to five treatment sessions given within 2 weeks duration.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT03556722 . Registered on 14 June 2018.

  9. Amano S, Ludin AF, Clift R, Nakazawa M, Law TD, Rush LJ, et al.
    Trials, 2016;17:81.
    PMID: 26867541 DOI: 10.1186/s13063-016-1214-7
    Low back pain is a highly prevalent condition in the United States and has a staggeringly negative impact on society in terms of expenses and disability. It has previously been suggested that rehabilitation strategies for persons with recurrent low back pain should be directed to the medial back muscles as these muscles provide functional support of the lumbar region. However, many individuals with low back pain cannot safely and effectively induce trunk muscle adaptation using traditional high-load resistance exercise, and no viable low-load protocols to induce trunk extensor muscle adaptation exist. Herein, we present the study protocol for a randomized controlled trial that will investigate the "cross-transfer" of effects of a novel exercise modality, blood flow restricted exercise, on cross-sectional area (primary outcome), strength and endurance (secondary outcomes) of trunk extensor muscles, as well as the pain, disability, and rate of recurrence of low back pain (tertiary outcomes).
  10. A'zim AZA, Zaid ZA, Yusof BNM, Jabar MF, Shahar ASM
    Trials, 2022 Nov 26;23(1):961.
    PMID: 36435838 DOI: 10.1186/s13063-022-06898-2
    BACKGROUND: Perioperative malnutrition is common in patients undergoing gastrointestinal-oncology surgery and is associated with longer hospital stays, increased postoperative complications, poorer quality of life, and lower survival rates. Current practice emphasizes the role of early perioperative nutrition therapy as an early intervention to combat the postoperative complications of patients and the implementation is now widely adopted. However, there is still a lack of research on determining the effectiveness of intensive nutrition therapy and providing ONS perioperative locally. This becomes the significance of this study and serves as a basis for management and guideline in the local hospital settings.

    METHODS: This is a pragmatic randomized control trial study where elective admitted patients will be randomly divided into the intervention (SS) or control (NN) group. All data will be collected during a face-to-face interview, anthropometric measurement, blood sampling (albumin, white blood count, hemoglobin, and c-reactive protein), handgrip strength, and postoperative complications. Group SS will be receiving a tailored lifestyle and intensively supplemented with oral nutrition support as compared to Group NN that will receive standard medical care. The primary outcome for this study is the length of stay in the hospital. Additional outcome measures are changes in biochemical profile and nutritional and functional status. The effects of intervention between groups on the outcome parameters will be analyzed by using the SPSS General Linear Model (GLM) for the repeated measure procedure.

    DISCUSSION: The intervention implemented in this study will serve as baseline data in providing appropriate nutritional management in patients undergoing gastrointestinal and oncological surgery.

    TRIAL REGISTRATION: ClinicalTrials.gov Protocol Registration and Results System (PRS) NCT04347772 . Registered on 20 November 2019.

    Matched MeSH terms: Randomized Controlled Trials as Topic; Pragmatic Clinical Trials as Topic
  11. Xiao Z, Hu L, Lin J, Lu L, Huang X, Zhu X, et al.
    Trials, 2020 Jan 16;21(1):94.
    PMID: 31948475 DOI: 10.1186/s13063-019-3982-3
    BACKGROUND: Chemotherapy-related fatigue (CRF) is a common symptom in non-small cell lung cancer (NSCLC) patients. A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in the First Affiliated Hospital of Guangzhou University of Chinese Medicine as an internal preparation for CRF and is associated with a promising response. Due to the lack of high-quality clinical evidence, a randomized placebo-controlled trial is required to assess the efficacy and safety of JPSS.

    METHODS/DESIGN: The efficacy and safety of JPSS herbal formula cream will be evaluated through a prospective, randomized, placebo-controlled trial conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. NSCLC patients with CRF will be randomized into two groups at a ratio of 1:1. Each group will receive either 15 g of the oral JPSS herbal formula cream or placebo twice a day from day 6 to day 20 during two courses of paclitaxel + platinum/docetaxel + platinum/pemetrexed + platinum (TP/DP/AP) chemotherapy. The primary endpoint is the difference in the degree of fatigue between baseline (the day before the start of the intervention) and day 42, which will be assessed by the Revised Piper Fatigue Scale score. The secondary endpoints are quality of life (measured by the 43-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer C43), Eastern Cooperative Oncology Group Performance Status, and Traditional Chinese Medicine syndrome score. The toxicity of the treatments will also be evaluated at the same time. All outcomes will be measured at baseline, day 6, day 21, and day 42 of the treatment.

    DISCUSSION: This randomized trial will investigate the efficacy and safety of JPSS applied for CRF in patients with NSCLC.

    TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900023451. Registered on 28 May 2019.

  12. Arshed M, Zakar R, Umer MF, Kiran M, Ullah N, Iftikhar G, et al.
    Trials, 2023 Jul 10;24(1):448.
    PMID: 37424031 DOI: 10.1186/s13063-023-07472-0
    BACKGROUND: Hypertension is a highly relevant public health challenge. Digital interventions may support improving adherence to anti-hypertensive medications and alter health behavior. Therefore, this protocol describes a study that aims to assess the effectiveness of mHealth and educational support through peer counseling (Ed-counselling) to control blood pressure in hypertensive patients when compared to standard care.

    METHODS: We chose a double-blinded pragmatic randomized-controlled with factorial design for this investigation. The trial is going to recruit 1648 hypertensive patients with coronary artery disease at the age of 21 to 70 years. All participants will already be on anti-hypertensive medication and own a smartphone. They will be randomized into four groups with each having 412 participants. The first group will only receive standard care; while the second group, in addition to standard care, will receive monthly Ed-counselling (educational booklets with animated infographics and peer counseling); the third group will receive daily written and voice reminders and an education-led video once weekly together with standard care; while the fourth one gets both interventions given to second and third groups respectively. All groups will be followed-up for 1 year (0, 6, and 12 months). The primary outcome will be the change in systolic blood pressure while secondary outcomes include health-related quality of life and changes in medication adherence. For measuring changes in systolic blood pressure (SBP) and adherence scores difference at 0, 6, and 12 months between and within the group, parametric (ANOVA/repeated measure ANOVA) and non-parametric tests (Kruskal-Wallis test/Friedman test) will be used. By using the general estimating equation (GEE) with negative binomial regression, at 12 months, the covariates affecting primary and secondary outcomes will be determined and controlled. The analysis will be intention-to-treat. All the outcomes will be analyzed at 0, 6, and 12 months; however, the final analysis will be at 12 months from baseline.

    DISCUSSION: Besides adding up to existing evidence in the literature on the subject, our designed modules using mHealth technology can help in reducing hypertension-related morbidity and mortality in developing countries.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  13. Labree B, Hoare DJ, Fackrell K, Hall DA, Gascoyne LE, Sereda M
    Trials, 2022 Dec 21;23(1):1039.
    PMID: 36539777 DOI: 10.1186/s13063-022-07020-2
    BACKGROUND: Tinnitus is the awareness of a sound in the ear or head in the absence of an external source. It affects around 10-15% of people and current treatment options are limited. Experimental treatments include various forms of electrical stimulation of the brain. Currently, there is no consensus on the outcomes that should be measured when investigating the efficacy of this type of intervention for tinnitus. This study seeks to address this by establishing a Core Domain Set: a common standard of what specific tinnitus-related complaints are critical and important to assess in all clinical trials of electrical stimulation-based interventions for tinnitus.

    METHODS: A two-round online survey will be conducted, followed by a stakeholder consensus meeting to identify a Core Domain Set. Participants will belong to one of two stakeholder groups: healthcare users with lived experience of tinnitus, and professionals with relevant clinical, commercial, or research experience.

    DISCUSSION: This study will establish a Core Domain Set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. The resulting Core Domain Set will act as a minimum standard for reporting in future clinical trials of electrical stimulation interventions for tinnitus. Standardisation will facilitate comparability of research findings.

  14. El Hajj MS, Awaisu A, Kheir N, Mohamed MHN, Haddad RS, Saleh RA, et al.
    Trials, 2019 Jan 08;20(1):25.
    PMID: 30621772 DOI: 10.1186/s13063-018-3068-7
    BACKGROUND: Tobacco use is presently responsible for the death of over seven million people across the world. In Qatar, it is one of the main causes of premature deaths and preventable diseases. To reduce tobacco use, Qatar has ratified the World Health Organization (WHO)'s Framework Convention on Tobacco Control (FCTC) and has implemented many tobacco-control initiatives. In spite of these measures, tobacco use is still considered a public health threat in Qatar. Pharmacists practicing in retail/community pharmacy settings are often the first port of call for individuals requiring general health advice. Evidence has proven that they have a pivotal role in health promotion and disease prevention including tobacco cessation. However, pharmacists in Qatar are not actively involved in tobacco control and many have not received any education or training about smoking cessation counseling in the past. In an effort to build the capacity of pharmacists towards tobacco control in Qatar, the aim of the proposed study is to design, implement, and evaluate an intensive education program on tobacco dependence treatment for pharmacists in Qatar.

    METHODS/DESIGN: The study will be a prospective randomized controlled trial comparing an intensive tobacco-related education program versus non-tobacco-related training on pharmacists' tobacco-use-related knowledge, attitudes, self-efficacy, and skills. Community pharmacists practicing in Qatar will be eligible for participation in the study. A random sample of pharmacists will be selected for participation. Consenting participants will be randomly allocated to intervention or control groups. Participants in the intervention group will receive an intensive education program delivered by a multi-disciplinary group of educators, researchers, and clinicians with expertise in tobacco cessation. A short didactic session on a non-tobacco-related topic will be delivered to pharmacists in the control group. The study has two primary outcomes: post-intervention tobacco-related knowledge and post-intervention skills for tobacco cessation assessed using a multiple-choice-based evaluation instrument and an Objective Structured Clinical Examination (OSCE), respectively. The secondary study outcomes are post-intervention attitudes towards tobacco cessation and self-efficacy in tobacco-cessation interventions assessed using a survey instrument. An additional secondary study outcome is the post-intervention performance difference in relation to tobacco-cessation skills in the practice setting assessed using the simulated client approach.

    DISCUSSION: If demonstrated to be effective, this education program will be considered as a model that Qatar and the Middle East region can apply to overcome the burden of tobacco-use disorder.

    TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03518476 . Registered on 8 May 2018. Version 1/22 June 2018.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  15. Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud Z', Md Yusop NB
    Trials, 2020 Jun 16;21(1):533.
    PMID: 32546217 DOI: 10.1186/s13063-020-04462-4
    INTRODUCTION: There has been growing evidence on the favourable outcomes of fast-track-recovery (FTR) surgery; to expedite recovery, minimise complications, and reduce the length of hospital stay for surgical patients. However, there is lack of evidence on the effectiveness of FTR in surgical gynaecological cancer (GC) patients. Most of the previous studies did not focus on feeding composition in the FTR surgery protocol. This study aims to determine the effectiveness of FTR feeding with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively on post-operative outcomes among surgical GC patients.

    METHODS/DESIGN: This open-labelled, randomised controlled trial (RCT) will randomly allocate patients into intervention and control groups. Ambulated Malaysian aged over 18 years and scheduled for elective surgery for (suspected) GC, will be included in this study. The intervention group will be given whey-protein-infused carbohydrate-loading drinks on the evening before their operation and 3 h before their operation as well as started on early oral feeding 4 h post-operatively. The control group will be fasted overnight pre-operation and only allowed plain water, and return to a normal diet is allowed when bowel sounds return post-operatively. The primary outcomes of study are length of post-operative hospital stay, length of clear-fluid tolerance, solid-food tolerance and bowel function. Additional outcome measures are changes in nutritional status, biochemical profile and functional status. Data will be analysed on an intention-to-treat basis.

    TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03667755. Retrospectively registered on 12 September 2018; Protocol version: version 3 dated 27 September 2017.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  16. Ahmed S, Butterworth P, Barwick A, Sharma A, Hasan MZ, Nancarrow S
    Trials, 2022 Dec 16;23(1):1017.
    PMID: 36527100 DOI: 10.1186/s13063-022-06968-5
    BACKGROUND: Foot complications occur in conjunction with poorly controlled diabetes. Plantar forefoot ulceration contributes to partial amputation in unstable diabetics, and the risk increases with concomitant neuropathy. Reducing peak plantar forefoot pressure reduces ulcer occurrence and recurrence. Footwear and insoles are used to offload the neuropathic foot, but the success of offloading is dependent on patient adherence. This study aims to determine which design and modification features of footwear and insoles improve forefoot plantar pressure offloading and adherence in people with diabetes and neuropathy.

    METHODS: This study, involving a series of N-of-1 trials, included 21 participants who had a history of neuropathic plantar forefoot ulcers. Participants were recruited from two public hospitals and one private podiatry clinic in Sydney, New South Wales, Australia. This trial is non-randomised and unblinded. Participants will be recruited from three sites, including two high-risk foot services and a private podiatry clinic in Sydney, Australia. Mobilemat™ and F-Scan® plantar pressure mapping systems by TekScan® (Boston, USA) will be used to measure barefoot and in-shoe plantar pressures. Participants' self-reports will be used to quantify the wearing period over a certain period of between 2 and 4 weeks during the trial. Participant preference toward footwear, insole design and quality-of-life-related information will be collected and analysed. The descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics (version 27). And the software NVivo (version 12) will be utilised for the qualitative data analysis.

    DISCUSSION: This is the first trial assessing footwear and insole interventions in people with diabetes by using a series of N-of-1 trials. Reporting self-declared wearing periods and participants' preferences on footwear style and aesthetics are the important approaches for this trial. Patient-centric device designs are the key to therapeutic outcomes, and this study is designed with that strategy in mind.

    TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000699965p. Registered on June 23, 2020.

  17. Naqvi AA, Hassali MA, Naqvi SBS, Aftab MT
    Trials, 2019 Aug 09;20(1):488.
    PMID: 31399128 DOI: 10.1186/s13063-019-3540-z
    BACKGROUND: The objective of this study is to evaluate the effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health-related quality of life (HRQoL) and direct cost of treatment. The study also documents patient satisfaction with pharmacist counselling as a quality control measure.

    METHODS/DESIGN: This is a randomized, single-blind, two-arm, controlled trial in patients with rheumatoid arthritis visiting outpatient rheumatology clinics in Karachi, Pakistan. We will enroll patients with established diagnosis of rheumatoid arthritis over 3 months. The patients would be randomized through a computer-generated list into the control group, i.e., usual care or into the intervention group, i.e., pharmaceutical care, in a ratio of 1:1, after providing signed written consent. The study will take place in two patient-visits over the course of 3 months. Patients in the intervention group would receive intervention from the pharmacist while those in the control group will receive usual care. Primary outcomes include change in mean score from baseline (week 0) and at follow up (week 12) in disease knowledge, adherence to medications and rehabilitation/physical therapy. The secondary outcomes include change in the mean direct cost of treatment, HRQoL and patient satisfaction with pharmacist counselling.

    DISCUSSION: This is a novel study that evaluates the role of the pharmacist in improving treatment outcomes in patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for this patient population in Pakistan. The results of this trial would be published in a peer-reviewed journal.

    TRIAL REGISTRATION: ClinicalTrials.gov, NCT03827148 . Registered on February 2019.

  18. Lee YL, Lim YMF, Law KB, Sivasampu S
    Trials, 2020 Jun 16;21(1):530.
    PMID: 32546189 DOI: 10.1186/s13063-020-04349-4
    INTRODUCTION: There are few sources of published data on intra-cluster correlation coefficients (ICCs) amongst patients with type 2 diabetes (T2D) and/or hypertension in primary care, particularly in low- and middle-income countries. ICC values are necessary for determining the sample sizes of cluster randomized trials. Hence, we aim to report the ICC values for a range of measures from a cluster-based interventional study conducted in Malaysia.

    METHOD: Baseline data from a large study entitled Evaluation of Enhanced Primary Health Care interventions in public health clinics (EnPHC-EVA: Facility) were used in this analysis. Data from 40 public primary care clinics were collected through retrospective chart reviews and a patient exit survey. We calculated the ICCs for processes of care, clinical outcomes and patient experiences in patients with T2D and/or hypertension using the analysis of variance approach.

    RESULTS: Patient experience had the highest ICC values compared to processes of care and clinical outcomes. The ICC values ranged from 0.01 to 0.48 for processes of care. Generally, the ICC values for processes of care for patients with hypertension only are higher than those for T2D patients, with or without hypertension. However, both groups of patients have similar ICCs for antihypertensive medications use. In addition, similar ICC values were observed for clinical outcomes, ranging from 0.01 to 0.09. For patient experience, the ICCs were between 0.03 (proportion of patients who are willing to recommend the clinic to their friends and family) and 0.25 (for Patient Assessment of Chronic Illness Care item 9, Given a copy of my treatment plan).

    CONCLUSION: The reported ICCs and their respective 95% confidence intervals for T2D and hypertension will be useful for estimating sample sizes and improving efficiency of cluster trials conducted in the primary care setting, particularly for low- and middle-income countries.

    Matched MeSH terms: Randomized Controlled Trials as Topic/statistics & numerical data*
  19. Wright H, Harris PNA, Chatfield MD, Lye D, Henderson A, Harris-Brown T, et al.
    Trials, 2021 Dec 07;22(1):889.
    PMID: 34876196 DOI: 10.1186/s13063-021-05870-w
    BACKGROUND: Increasing rates of antibiotic resistance in Gram-negative organisms due to the presence of extended-spectrum beta-lactamases (ESBL), hyperproduction of AmpC enzymes, carbapenemases and other mechanisms of resistance are identified in common hospital- and healthcare-associated pathogens including Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii. Cefiderocol is a novel siderophore cephalosporin antibiotic with a catechol moiety on the 3-position side chain. Cefiderocol has been shown to be potent in vitro against a broad range of Gram-negative organisms, including carbapenem-resistant Enterobacteriaceae (CRE) and multi-drug-resistant (MDR) P. aeruginosa and A. baumannii. Recent clinical data has shown cefiderocol to be effective in the setting of complicated urinary tract infections and nosocomial pneumonia, but it has not yet been studied as treatment of bloodstream infection.

    METHODS: This study will use a multicentre, open-label non-inferiority trial design comparing cefiderocol and standard of care antibiotics. Eligible participants will be adult inpatients who are diagnosed with a bloodstream infection with a Gram-negative organism on the basis of a positive blood culture result where the acquisition meets the definition for healthcare-associated or hospital-acquired. It will compare cefiderocol with the current standard of care (SOC) antibiotic regimen according to the patient's treating clinician. Eligible participants will be randomised 1:1 to cefiderocol or SOC and receive 5-14 days of antibiotic therapy. Trial recruitment will occur in at least 20 sites in ten countries (Australia, Malaysia, Singapore, Thailand, Turkey and Greece). The sample size has been derived from an estimated 14 day, all-cause mortality rate of 10% in the control group, and a non-inferiority margin of 10% difference in the two groups. A minimum of 284 patients are required in total to achieve 80% power with a two-sided alpha level of 0.05. Data describing demographic information, risk factors, concomitant antibiotics, illness scores, microbiology, multidrug-resistant organism screening, discharge and mortality will be collected.

    DISCUSSION: With increasing antimicrobial resistance, there is a need for the development of new antibiotics with broad activity against Gram-negative pathogens such as cefiderocol. By selecting a population at risk for multi-drug-resistant pathogens and commencing study treatment early in the clinical illness (within 48 h of index blood culture) the trial hopes to provide guidance to clinicians of the efficacy of this novel agent.

    TRIAL REGISTRATION: The GAME CHANGER trial is registered under the US National Institute of Health ClinicalTrials.gov register, reference number NCT03869437 . Registered on March 11, 2019.

    Matched MeSH terms: Randomized Controlled Trials as Topic
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