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  1. Bhoo Pathy N, Uiterwaal CS, Taib NA, Verkooijen HM, Yip CH
    J Clin Epidemiol, 2012 May;65(5):568-71.
    PMID: 22269329 DOI: 10.1016/j.jclinepi.2011.09.013
    Many recent studies investigated the prognostic value of new biomarkers in breast cancer using data from cancer registries. Some of these studies were conducted using only patients for whom biomarker status was available (or tested). Using human epidermal growth factor receptor 2 (HER2) as an example, we determined whether testing for a recently introduced biomarker was associated with the outcome of women with breast cancer.
  2. Niti M, Ng TP, Chiam PC, Kua EH
    J Clin Epidemiol, 2007 Apr;60(4):366-74.
    PMID: 17346611
    Item response bias (also called differential item functioning, DIF) in Instrumental Activities of Daily Living (IADL) occurs when members of different groups possessing the same disability level do not have the same probability of responding positively for a given item(s). This study aimed to identify the extent of DIF by gender, age, ethnicity, and dementia groups in IADL estimates in Asian (Chinese, Malays, and Indian) elderly subjects.
  3. Lee PR, Lurie P, Silverman MM, Lydecker M
    J Clin Epidemiol, 1991;44 Suppl 2:49S-55S.
    PMID: 2045842
    Recent studies of drug promotion and labeling in Third World countries since 1972 have observed important changes in the policies of multinational corporations. Earlier studies found that multinational and national drug companies often grossly exaggerated the indications for the drugs and minimized or ignored the hazards. In the latest study, initiated in 1987, considerable improvement in promotional practices of the multinational corporations has been found, but little or no improvement on the part of the national companies. As a result, physicians are still provided with grossly exaggerated claims and the hazards of prescription drugs are covered up or glossed over. A very serious problem--the marketing of fraudulent drug products--has been identified in a number of Third World countries. Drug products are shaped and colored to resemble the original multinational company product, but contain only a small percentage of the active ingredient stated on the label, or perhaps none at all. In Indonesia fraudulent drug products may represent 20-30% of all drug products in the market. Similar fraudulent products have been reported in Brazil, Thailand, Bangladesh and Malaysia.
  4. Price A, Vasanthan L, Clarke M, Liew SM, Brice A, Burls A
    J Clin Epidemiol, 2019 01;105:27-39.
    PMID: 30171901 DOI: 10.1016/j.jclinepi.2018.08.017
    BACKGROUND AND OBJECTIVES: The growth of trials conducted over the internet has increased, but with little practical guidance for their conduct, and it is sometimes challenging for researchers to adapt the conventions used in face-to-face trials and maintain the validity of the work. The aim of the study is to systematically explore existing self-recruited online randomized trials of self-management interventions and analyze the trials to assess their strengths and weaknesses, the quality of reporting, and the involvement of lay persons as collaborators in the research process.

    STUDY DESIGN AND SETTINGS: The Online Randomized Controlled Trials of Health Information Database was used as the sampling frame to identify a subset of self-recruited online trials of self-management interventions. The authors cataloged what these online trials were assessing, appraised study quality, extracted information on how trials were run, and assessed the potential for bias. We searched out how public and patient participation was integrated into online trial design and how this was reported. We recorded patterns of use for registration, reporting, settings, informed consent, public involvement, supplementary materials, and dissemination planning.

    RESULTS: The sample included 41 online trials published from 2002 to 2015. The barriers to replicability and risk of bias in online trials included inadequate reporting of blinding in 28/41 (68%) studies; high attrition rates with incomplete or unreported data in 30/41 (73%) of trials; and 26/41 (63%) of studies were at high risk for selection bias as trial registrations were unreported. The methods for (23/41, 56%) trials contained insufficient information to replicate the trial, 19/41 did not report piloting the intervention. Only 2/41 studies were cross-platform compatible. Public involvement was most common for advisory roles (n = 9, 22%), and in the design, usability testing, and piloting of user materials (n = 9, 22%).

    CONCLUSION: This study catalogs the state of online trials of self-management in the early 21st century and provides insights for online trials development as early as the protocol planning stage. Reporting of trials was generally poor and, in addition to recommending that authors report their trials in accordance with CONSORT guidelines, we make recommendations for researchers writing protocols, reporting on and evaluating online trials. The research highlights considerable room for improvement in trial registration, reporting of methods, data management plans, and public and patient involvement in self-recruited online trials of self-management interventions.

  5. Negrini S, Arienti C, Pollet J, Engkasan JP, Francisco GE, Frontera WR, et al.
    J Clin Epidemiol, 2019 10;114:108-117.
    PMID: 31220570 DOI: 10.1016/j.jclinepi.2019.06.008
    OBJECTIVE: The objective of this study was to study if randomized controlled trials (RCTs) in rehabilitation (a field where complex interventions prevail) published in main journals include all the details needed to replicate the intervention in clinical practice (clinical replicability).

    STUDY DESIGN AND SETTING: Forty-seven rehabilitation clinicians of 5 professions from 7 teams (Belgium, Italy, Malaysia, Pakistan, Poland, Puerto Rico, the USA) reviewed 76 RCTs published by main rehabilitation journals exploring 14 domains chosen through consensus and piloting.

    RESULTS: The response rate was 99%. Inter-rater agreement was moderate/good. All clinicians considered unanimously 12 (16%) RCTs clinically replicable and none not replicable. At least one "absent" information was found by all participants in 60 RCTs (79%), and by a minimum of 85% in the remaining 16 (21%). Information considered to be less well described (8-19% "perfect" information) included two providers (skills, experience) and two delivery (cautions, relationships) items. The best described (50-79% "perfect") were the classic methodological items included in CONSORT (descending order: participants, materials, procedures, setting, and intervention).

    CONCLUSION: Clinical replicability must be considered in RCTs reporting, particularly for complex interventions. Classical methodological checklists such as CONSORT are not enough, and also Template for Intervention Description and Clinical replication do not cover all the requirements. This study supports the need for field-specific checklists.

  6. Dewidar O, Kawala BA, Antequera A, Tricco AC, Tovey D, Straus S, et al.
    J Clin Epidemiol, 2022 Oct;150:142-153.
    PMID: 35863618 DOI: 10.1016/j.jclinepi.2022.07.007
    OBJECTIVES: We provide guidance for considering equity in rapid reviews through examples of published COVID-19 rapid reviews.

    STUDY DESIGN AND SETTING: This guidance was developed based on a series of methodological meetings, review of internationally renowned guidance such as the Cochrane Handbook and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis for equity-focused systematic reviews (PRISMA-Equity) guideline. We identified Exemplar rapid reviews by searching COVID-19 databases and requesting examples from our team.

    RESULTS: We proposed the following key steps: 1. involve relevant stakeholders with lived experience in the conduct and design of the review; 2. reflect on equity, inclusion and privilege in team values and composition; 3. develop research question to assess health inequities; 4. conduct searches in relevant disciplinary databases; 5. collect data and critically appraise recruitment, retention and attrition for populations experiencing inequities; 6. analyse evidence on equity; 7. evaluate the applicability of findings to populations experiencing inequities; and 8. adhere to reporting guidelines for communicating review findings. We illustrated these methods through rapid review examples.

    CONCLUSION: Implementing this guidance could contribute to improving equity considerations in rapid reviews produced in public health emergencies, and help policymakers better understand the distributional impact of diseases on the population.

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