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Methodological Issues and Challenges in eHealth Research Panel [Aud   900   Proudfoot (Panel)]
 

Methodological Issues and Challenges in eHealth Research Panel [Aud 900 Proudfoot (Panel)]

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Methodological Issues and Challenges in eHealth Research Panel [Aud   900   Proudfoot (Panel)] Methodological Issues and Challenges in eHealth Research Panel [Aud 900 Proudfoot (Panel)] Presentation Transcript

  • Proudfoot, J. et al.: Methodological Issues and Challenges in eHealth Research Panel
    • This slideshow, presented at Medicine 2.0’08 , Sept 4/5 th , 2008, in Toronto, was uploaded on behalf of the presenter by the Medicine 2.0 team
    • Do not miss the next Medicine 2.0 congress on 17/18th Sept 2009 ( www.medicine20congress.com )
    • Order Audio Recordings (mp3) of Medicine 2.0’08 presentations at http://www.medicine20congress.com/mp3.php
  • Methodological Issues and Challenges in eHealth Research Dr Judy Proudfoot , Black Dog Institute & School of Psychiatry, University of New South Wales, Sydney, Australia. Dr Lisa Whitehead , University of Otago, Christchurch, New Zealand. Dr Caryl Barnes , School of Psychiatry, University of New South Wales, Sydney, and Sentiens, Perth, Australia
  •  
  • Session Outline
    • Introduction
    • Systematic review of methodological and ethical issues in Internet research
    • Sampling issues
    • Ethical issues
    • Measurement issues
    • Discussion
    • Conclusion
  • Systematic review of methodological and ethical issues in Internet research Dr Lisa Whitehead
  • Search strategy
    • 8 databases (EBSCO,EMBASE, Medline, PsycInfo, CINAHL, PubMed, Cochrane and TRIP).
    • Keywords: Internet, research, quality, credibility, reliability and validity.
    • Quality appraisal (Dixon-Woods et al. 2005).
    • Whitehead, L. (2007) Methodological and ethical issues in Internet-mediated research in the field of health: An integrated review of the literature. Social Science and Medicine 65: 782-791
  • 3 Key Issues Sampling issues Ethical issues Reliability and validity
    • 3 key issues
      • Potential for sampling bias
      • Ethical issues in Internet research?
      • Validity of the data- impact on the established psychometric properties of measures
  • Sampling Issues
    • Two approaches (open and selective)
      • Open (convenience sampling)
    • Enhance representation?
    • Can large samples override potential bias?
    • Presence and impact of self-selection can be traced to some degree
  • Sampling issues
    • Selective (if able to define population)
      • Few studies based on a randomly selected sample
      • Convenience sample random allocation
      • Propensity scoring an option
  • Response rates
    • Unsolicited e-mail (with electronic return) generates lowest response rate, even when compared to unsolicited postal survey.
    • Impact of presentation- browser type, download time, password, security issues, computer anxiety, computer self-efficacy
  • Ethical Issues
    • Seeking/obtaining consent
    • Protecting participants’ anonymity
    • Security of site
    • Opportunistic research
  • Ethical issues in planned research
    • Developing informed consent
    • Ability to ensure a level of anonymity
    • Security of site
  • Opportunistic research
    • When and how is material posted on the web classed as public or private?
      • Level of “disguise” in presenting results?
      • Issue of perceived privacy
      • Are researchers “lurkers”?
      • Is the process of “non-alienation” acceptable?
  • Reliability and validity
    • Equivalence must be demonstrated not assumed
      • Some evidence of differences in the distribution of scores and psychometric properties (e.g. factor loading)
  • Reliability and credibility
    • Layout of pages
    • Linguistic competence
    • Culturally driven interpretations
    • Low attentiveness
    • Repeat participation
    • Incomplete submissions
    • Misrepresentation of self
  • Construct validity
    • Psychometric properties
      • Mixed evidence
      • How critical are the differences?
      • Difficult to disentangle issues around sampling biases and possible effects of completing measures on-line.
  • Sampling Issues in Internet-Mediated Research Dr Judy Proudfoot
  • Online Psychoeducation for Bipolar Disorder: Randomised Controlled Trial
    • Dr Judy Proudfoot – Black Dog Institute & School of Psychiatry, University of New South Wales
    • Amisha Jawawant - Black Dog Institute & School of Psychiatry, University of New South Wales
    • Prof. Gordon Parker – Black Dog Institute & School of Psychiatry, University of New South Wales
    • A/Prof Vijaya Manicavasagar – Black Dog Institute & School of Psychiatry, University of New South Wales
    • A/Prof Meg Smith – University of Western Sydney
  • Background
    • Bipolar Disorder is difficult to detect. Accurate diagnosis can take 10-20 years.
    • Poor treatment adherence, inadequate self management, increased levels of disability are common.
    • 40% of patients relapse in 1 year, 60% over 2 years and 73% over 5 years (Gitlin et al, Am J Psych, 1995) .
    • Psycho-education reduces relapses and hospitalisations. Not previously delivered online.
  • Research Study
    • RANDOMISED CONTROLLED TRIAL
    • Does an 8-module online education program + ‘treatment as usual’ for Bipolar Disorder improve psycho-social adjustment in adults with newly-diagnosed BD
    • With and without online support from an apomediary (“informed supporter”).
    • In comparison with online information about bipolar disorder + monitoring.
  • Bipolar Disorder Education Program
  • Topics
    • Diagnosing Bipolar Disorder
    • Causes of Bipolar disorder
    • Medications
    • Psychological Treatments
    • Stay-Well Plans (identifying triggers and early warning signs, and designing preemptive actions involving pt and family)
    • Support Networks and Carers
    • Omega-3 as a treatment for depression
    • Person First Illness Last
  • Random Allocation Bipolar Disorder Education Program Email support from an apomediary + lnformation + Monitoring
  • Online interventions
    • One online module per week over 8 weeks
    • Workbook activities to assist participants to apply the information and strategies to their situation
    • Self-monitoring between sessions
  • “Informed Supporters”
    • People with bipolar disorder
    • Effectively managing their condition for >2 years
    • Trained to provide email support to participants under supervision of our clinical team.
  • Informed Support
    • At least one and maximum two emails per week sent to each participant (max 300 words per email), with invitation to respond.
    • Practical advice about how to set up a “well-being plan” (strategies to minimise risks and illness triggers and a contingency plan for times when unwell) as well as general issues about bipolar disorder.
    • Posts from Informed Supporters are checked for adherence and safety.
    • Posts from participants to Informed Supporters are monitored for adverse events.
  • Inclusion Criteria:
    • 18+ years old
    • Diagnosed with BD in previous 12 months
    • Currently receiving regular care from psychiatrist or GP
    • Has access to internet and printer, and is computer literate
    • Able to read and write English
    • Living in Australia
  • Screening
    • Bipolar Disorder Assessment Test (Parker et al., 2006) Sensitivity: Specificity:
    • Potential for over-ride by Black Dog Institute Psychiatrists (who validated the BDAT)
  • Sampling
    • Open (convenience) sampling: - Via Internet Black Dog Institute website, websites of professional organisations, websites of mental health organisations in Australia - Via print media Newspaper advertisements and articles
  • Sampling (cont)
    • Selective Sampling:
    • - Via Black Dog Institute Mood Disorders Clinic – invited participation - Via leaflets at special events , eg Fun Runs, Flower Festivals, Training programs for GPs, School Counsellors
  • Sampling (cont)
    • Variety of recruitment methods to minimise sampling bias and maximise response rates.
    • But still not a random sample (ie each member of the population does not have equal probability of being selected).
    • No recruitment by unsolicited email (lower response rate).
    • But still low response rate (3-4 per week) - due to tight inclusion criteria?
    • - due to phenomenology of BD diagnosis?
  • A Solution?
  • Methodological Issues and Ethical Challenges in e-Health Research: Panel Discussion Dr Caryl Barnes MBBS,FRANZCP Doctoral fellow University of New South Wales, Sydney, Australia ‘ HealthSteps (formally Recovery Road) for Bipolar Disorder’: an on-line relapse prevention program
  • Overview
    • Bipolar disorder: role of internet in treatment
    • Aims of RCT: ‘ Taking control of Bipolar Disorder: Staying well, Learning more’-12 month online relapse prevention program
    • Ethical issues considered
        • Privacy/Confidentiality/Anonymity
        • Informed consent
        • Analysis of potential risk to participants/ benefits
        • Beneficence/ Duty-of-care
    • Discussion
  • Bipolar Disorder: role of internet in treatment
    • Common 1-2% of the general population
    • Chronic relapsing remitting illness
    • 6th highest cause of disability world wide (WHO figures)
    • Frequent relapses despite good adherence to medication
    • Psychological interventions vital part of treatment e.g. psycho-education / CBT
    • Disadvantages
      • time consuming,
      • expensive
      • depending on area, difficult to access
  • Research Team: collaboration between public/private
    • University of New South Wales
    • Dr Caryl Barnes-Chief Investigator, Consultant Psychiatrist/ Doctoral fellow
    • Dusan Hadiz-Pavlovic, Senior Hospital Scientist
    • Professor Philip Mitchell, Head of School of Psychiatry
    • Assoc Professor Kay Wilhelm
    • Sentiens Pty Ltd
    • Dr Dennis Tannenbaum, CEO
    • Dr Caroline Spiranovic, Research and Development Associate
    • Gavin Pinto, IT Architect
    • Michael Bosley-Smith, Research Officer
    • Stacey Bosley-Smith, Research Officer
    • Dr Robin Harvey, Research Manager
    Perth Western Australia Sydney, NSW
  • Aims of 12-month RCT
    • To evaluate on-line adjunctive relapse prevention program ‘HealthSteps for Bipolar Disorder’ vs. placebo/control program ‘Virtual Highway for Bipolar Disorder’
    • Outcome measures:
      • Time to relapse- Survival analysis
      • Measures: BDI-II, ISS, Sheehan disability scale, Hospitalization,
  • Study Inclusion Criteria
    • Over 18 years of age
    • Meets criteria for bipolar disorder (BDSQ Confirmed)
    • Diagnosis made by a mental health professional
    • Currently under care of psychiatrist /GP
    • Taking medication
    • Access to internet and printer- at home/ work.
    • Has an email account/ has email address.
    • Able to understand written English
    • Interested in using web based program
  • Study Inclusion Criteria
    • Over 18 years of age
    • Meets criteria for bipolar disorder (BDSQ Confirmed)
    • Diagnosis made by a mental health professional
    • Currently under care of psychiatrist /GP
    • Taking medication
    • Access to internet and printer- at home/ work.
    • Has an email account/ has email address.
    • Able to understand written English
    • Interested in using web based program
  •  
  • Ethical Considerations: Getting started
    • UNSW Human Research Ethics Committee (HREC)
      • Formal application process
      • Consist of a diverse panel includes ’lay’ members
      • Issues
        • Privacy/Confidentiality/Anonymity
        • Informed consent
        • Analysis of potential risk to participants/ benefits
        • Beneficence/ Duty-of-care
  • Privacy/ Confidentiality
    • Screening/Recruitment-BDSQ
      • Only contact email required
      • Minimal identifying details collected
      • Contact participants via email only
      • Secure database/server
      • Professional standards for confidentiality
    • Online Enrolment/Access to study
      • Allocation 8 digit individual ID number/password
    • Data entered during study
      • De-identification
      • Secure data storage -fire walled
      • Limited access
  •  
  • Privacy / Confidentiality
  • Informed Consent
    • Consent for Study: Two-way process
      • Provide information about requirements, risks and benefits of the study
      • Ensure level of common understanding about study is reached
    • Information via online ‘Participation Information statement’ start of BDSQ
    • Used ‘click-button’ option.
    • Consent to inform treating clinician optional
    • Participant able to withdraw consent at any point
    • Technical support given via s [email_address] .au
    • Screen shots in here
  •  
  • Risks/Benefit Ratio
    • Low risk of inducing psychological distress
    • No risk of physical harm
    • Vulnerable population recognized; inclusion criteria had to be under care treating mental health professional
    • Program adjunctive only
    • Belief participation would benefit participants
  • Duty of Care
    • Need to recognize worsening/ life threatening symptoms/ suicidal ideation
    • Developed a RED FLAG system
    • Outcome measures set to trigger flag within system
    • Individual data entry reviewed, if required de-identification participant, review of consents
    • Email to participant, if applicable to treating clinician
  •  
  • Discussion
    • Restraints caused by a research collaboration-private and public entities
    • Privacy- not enough identifying details collected
    • Informed consent process – was this sufficient?
    • Risk/Benefit
      • email
      • Ongoing clinician contact?
  • Discussion
    • Duty of care
      • Management of participants outside of Australia
      • Red flag system appreciated-feedback received rated this most useful components of study
      • Consent to contact clinician optional, is this sufficient?
      • Control group going into HealthSteps lack of resources limited retention some features e.g. Red Flags
  • Acknowledgements
    • Graduate Research School and Faculty of Medicine, University of New South Wales, Sydney, Australia
      • Travel Scholarship and Doctoral Scholarship
    • Dr Dennis Tannebaum, CEO and all Research Staff at Sentiens Pty Ltd
    • Professor Philip Mitchell : Doctorate Supervisor
    For a sustainable future in research The 5.31 tonnes of Co2 produced by the author’s flights from Australia to Pittsburgh to present this poster for the 7 th ICBD have been offset with www.climatecare.org.
  • Carbon Neutral: for a sustainable future in research The 6.09 tonnes of Co2 produced by the presenter’s flights from Perth, Western Australia to Toronto for the Medicine 2.0 Conference has been offset with www.climatecare.org.
  • The health of tertiary students: A mixed method study Dr Lisa Whitehead, Dr Shelagh Dawson, Avin Panckhurst Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand
  • Methods
      • Student population of 20,665
      • A random sample of 2000 students was taken and these were randomly assigned to either a postal (N=1000) or an on-line survey (N=1000).
      • The survey was about physical and emotional health, anxiety, depression and fatigue
  • Sampling Issues
    • Response rates
  • Pattern of response
  • Sampling issues
  • Correlations between measures
  • Distribution of scores- Single fatigue item Table 4. Single item fatigue measure (I feel tired for no reason) X 2 =0.07 df=1 p=0.79 (Armitage-Cochran test for trend) 969 39 90 424 416 Total 497 19 (3.8%) 52 (10.4%) 212 (42.7%) 214 (43.1%) Postal 472 20 (4.2%) 38 (8.1%) 212 (44.9%) 202 (42.8%) On-line Total 3 (Most of the time) 2 (A good part of the time) 1 (Some of the time) 0 (none or a little of the time)
  • Mean differences
  • Construct validity FSI- Mean differences in fatigue between the on-line and postal group
  • Mean differences on FSI items on-line, postal and scale development group
  • Correlations among the fatigue intensity and duration ratings as an indication of the construct validity of the FSI
  • Reach Out Central Evaluation Swinburne eTherapy Unit www.swinburne.edu.au/lss/swinpsyche/etherapy
  • www.reachout.com.au
    • Online game-based youth mental health education program
    • Target audience:
      • young people aged 16-25, particularly young men.
    • Objectives:
      • Increase mental health literacy
      • Increase skills to change thoughts and solve problems
      • Application of learned skills to improve mental health
    ROC Overview
  • Methodology
    • Single group, quasi-experimental repeated measures design (pre-, post-program and follow-up)
    • N = 266 (176 females; 88 males)
    • Questionnaires included:
      • K10 (depression and anxiety)
      • AUDIT (alcohol use)
      • Coping Strategy Indicator – short form (subscales – problem solving , seeking support, avoidance)
      • Resilience Scale – short form (RS – SF)
      • Satisfaction with Life Scale (SWLS)
    • Additional items examined drug use, mental health stigma, help seeking attitudes, program satisfaction and application of skills in day-to-day life.
  • Issues for Discussion
    • What is the minimal process considered sufficient for informed consent?
    • Are we overconcerned with privacy?
    • What are the minimal requirements for duty of care?
    • What is your experience in the transfer of measures to the online setting?
    • Should standard measures be robust enough to cope with minor variance?
    • How generalisable are the results from Internet studies (convenience samples)?
    • How can the generalisability be improved?
    • Can inferences be drawn from randomised controlled trials within convenience samples?