Monday, October 27, 2014

The Rest of ASBH

And here are more programs from the recent conference of the American Society for Bioethics and Humanities. And may I say, Buffy the Vampire Slayer came up in one of the sessions!
  • Made vulnerable: notes of privilege; or how when you say their name, the bodies go missing
  • Assessing public attitudes about the ethics of research on medical practice
  • Beneath the covers: film, philosophy and sex
  • Moral sources for collaborative, practice-based ethics: a transformation for education and practice
  • Theory confirmation, risk and hermeneutics in the early phases of medical research
  • Shared vulnerabilities in research
  • Guinea pigs for peace: why American World War II conscientious objectors volunteered as research subjects
  • Fiction and bioethics: from speculation to practice 
  • My donor taught me: reflections from anatomy lab
  • Building research integrity and capacity: professional development for research support staff
  • Ethics of authorship in interprofessional team-based research
  • Big brother is watching? The ethics of electronic adherence monitoring- an interdisciplinary outlook
  • Migration and health: opportunities and challenges from the bioethics perspective
  • Industry-academy relations: ethical and policy concerns
  • Whole genome sequencing: the devil in the DNA
  • Ethics in the CTSA program: past, present and a changing future
  • Understanding patients’ views on consent for research enrollment in the setting of acute cardiac illness
  • Exploring ethics rationales for patient engagement in research
  • Medical researchers’ ancillary care obligations: a relationship-based approach
  • How to write an exam in bioethics

Monday, October 13, 2014

ASBH Annual Conference 2014

Later this week I will be attending the annual conference of the American Society for Bioethics and Humanities. This is the nation’s largest bioethics conference, and it is always highly entertaining and educational. It makes me consider issues from new perspectives and it shows the full gamut of bioethics scholarship across the country. It features some of the world’s leading ethicists and philosophers, and it also includes many sessions where people working in the field present their research. There are preconference workshops, plenary sessions, paper sessions and affinity group meetings. The affinity groups are groups who gather around common interests. For example, there is an affinity group on rural bioethics, one on Jewish bioethics, another on sexuality and gender identity, one on neuroethics, and so on. These are less formal meetings that occur over meal hours, where people can discuss common interests. I usually try to attend the affinity group on research, and then on whatever hits my fancy at the time.

Below is a list of the general sessions, which will give you an overview of the scope of the conference.

  • Articulating the Goals and Assessing the Impact of Bioethics Projects: A Report from the ABPD Working Group
  • Made Vulnerable: Notes on Privilege; or, How When You Say Their Names, the Bodies Go Missing
  • Moral Sources for Collaborative, Practice-Based Ethics: A Transformation for Education and Practice
  • Sanctity of Life, by L. J. Schneiderman: A Staged Reading
  • Collaborative Solutions to Challenges in Health Care and Education: A Forum Theatre Workshop
  • Bioethics Literacy Across the Lifespan
  • Migration and Health: Opportunities and Challenges from the Bioethics Perspective
  • A Global Perspective on Women’s Rights to Health and Safety: Progress or Regress?
  • From Clinical to Community Sequencing: Emerging Ethical, Legal, and Social Issues in Genomics
We are off at the Davenport campus next week, so I will post upon my return.

Monday, October 6, 2014

The Common Rule: General requirements for Informed Consent

I know that a good number of us have been developing and conducting research in our educational setting. And there are times when we will need to consider developing a consent document; however, not all of us have experience in writing one. Federal law actually stipulates what must be in a consent document, and rather than me summarizing those elements for you, I thought I would simply provide you the specific language, from 45CFR46 (46.116)(1).

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

 (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
 (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
 (2) A description of any reasonably foreseeable risks or discomforts to the subject;
 (3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
 (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
 (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
 (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
 (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
 (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
 (b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
 (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
 (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
 (3) Any additional costs to the subject that may result from participation in the research;
 (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
 (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
 (6) The approximate number of subjects involved in the study.
 (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
 (1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
 (2) The research could not practicably be carried out without the waiver or alteration.
 (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
 (1) The research involves no more than minimal risk to the subjects;
 (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
 (3) The research could not practicably be carried out without the waiver or alteration; and
 (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
 (e) The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
 (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.

References

1.       http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html, accessed October 3, 2014

Monday, September 29, 2014

Three New Papers from Biomed Central Journals

Emary PC, Stuber KJ. Chiropractors' attitudes toward drug prescription rights: a narrative review. Chiropr Man Ther 2014, 22:34  doi:10.1186/s12998-014-0034-7

ABSTRACT
Background: The right to prescribe drugs remains a contentious issue within the chiropractic profession. Nevertheless, drug prescription by manual therapy providers is currently an important topic. Notably, physiotherapists in the United Kingdom were recently granted limited independent prescribing rights. Reports suggest that physiotherapists in Australia now want those same rights, and as such a review of chiropractors? general attitudes toward drug prescription is needed.

Objective: To examine the literature concerning chiropractors’ attitudes toward drug prescription rights and to compare the opinions of chiropractors currently licensed to prescribe medication with those in the profession who are not.

Methods: This was a narrative review, consisting of a formal literature search and summary of included articles. Electronic databases searched included the Cumulative Index to Nursing and Allied Health Literature, PubMed, and the Index to Chiropractic Literature. Inclusion criteria consisted of prospective studies published in English in peer-reviewed journals. Studies were required to contain data on chiropractors’ opinions toward medication prescription rights.

Results: Of 33 articles identified, a total of seven surveys were included in the review. Of these, there was a general split in opinion among chiropractors regarding the right to prescribe drugs in chiropractic practice. Those supportive of prescribing rights favoured a limited number of over-the-counter and/or prescription-based medications such as analgesics, anti-inflammatories, and muscle relaxants. When questioned on full prescribing rights, however, chiropractors were generally opposed. In jurisdictions where chiropractors are currently licensed to prescribe from a limited formulary, such as in Switzerland, the majority perceived this right as an advantage for the profession. Moreover, continuing education in pharmacology was viewed as a necessary component of this privilege.

Conclusions: Based on the literature to date there is a general split in chiropractors? attitudes toward drug prescription rights. This split is most pronounced in countries where chiropractors are not licensed to prescribe medications. Notwithstanding, this is an important topic in chiropractic currently and warrants both further discussion and research to determine future directions and the implications of either pursuit or denial of prescription rights by chiropractors. Future surveys and/or qualitative studies of other chiropractors? opinions toward gaining prescription privileges would be timely.

 
Kairouz VF, Raad D, Fudyma J, Curtis AB, Schunemann HJ, Akl EA. Assessment of faculty productivity in academic departments of medicine in the United States: a national survey. BMC Medical Education 2014, 14:205  doi:10.1186/1472-6920-14-205

ABSTRACT
Background: Faculty productivity is essential for academic medical centers striving to achieve excellence and national recognition. The objective of this study was to evaluate whether and how academic Departments of Medicine in the United States measure faculty productivity for the purpose of salary compensation.

Methods: We surveyed the Chairs of academic Departments of Medicine in the United States in 2012. We sent a paper-based questionnaire along with a personalized invitation letter by postal mail. For non-responders, we sent reminder letters, then called them and faxed them the questionnaire. The questionnaire included 8 questions with 23 tabulated close-ended items about the types of productivity measured (clinical, research, teaching, administrative) and the measurement strategies used. We conducted descriptive analyses.

Results: Chairs of 78 of 152 eligible departments responded to the survey (51% response rate). Overall, 82% of respondents reported measuring at least one type of faculty productivity for the purpose of salary compensation. Amongst those measuring faculty productivity, types measured were: clinical (98%), research (61%), teaching (62%), and administrative (64%). Percentages of respondents who reported the use of standardized measurements units (e.g., Relative Value Units (RVUs)) varied from 17% for administrative productivity to 95% for research productivity. Departments reported a wide variation of what exact activities are measured and how they are monetarily compensated. Most compensation plans take into account academic rank (77%). The majority of compensation plans are in the form of a bonus on top of a fixed salary (66%) and/or an adjustment of salary based on previous period productivity (55%).

Conclusion: Our survey suggests that most academic Departments of Medicine in the United States measure faculty productivity and convert it into standardized units for the purpose of salary compensation. The exact activities that are measured and how they are monetarily compensated varied substantially across departments.

 
Habets MGJL, van delden JJM, Bredenoor AL. The social value of clinical research. BMC Medical Ethics 2014, 15:66  doi:10.1186/1472-6939-15-66

ABSTRACT
Background: International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic.

Discussion: Our analysis and interpretation of the concept social value has led to three proposals. First, as no direct benefits are expected for the research participants in first-in-human trials, we believe it is better to discuss a risk- value assessment instead of a risk - benefit assessment. This will also make explicit the necessity to have a clear and common use for the concept social value. Second, to avoid confusion we propose to limit the concept social value to the intervention tested. It is the expected improvement the intervention can bring to the wellbeing of (future) patients or society that is referred to when we speak about social value. For the sole purpose of gaining knowledge, we should not expose humans to potential harm; the ultimate justification of involving humans in research lies in the anticipated social value of the intervention. Third, at the moment only the validity of the clinical research proposal is a prerequisite for research to take place. We recommend making the anticipated social value a prerequisite as well.

Summary: In this paper we analyze the use of the concept social value in research ethics. Despite its unavoidable ambiguity, we aim to find a best use of the concept, subject to its role in justifying involving humans in first-in-human research.

 

Monday, September 22, 2014

Citation Software

The new issue of Online Cl@ssroom has a nice little article devoted to citation software (1). Most of us are already familiar with at least one program that collects and organizes citations, namely RefWorks. For those in research, they use Refman, which is a more powerful citation tracker. But there are a number of other venders for these programs. Included among them are:

Zotero: available at www.zotero.com. This is a  free program that works across platforms and links itself to your browser. From its home page, it notes that it will automatically sense the content in your browser and then let you add it to your personal library. All the content is then placed into a single searchable interface, which is organized in a fashion similar to an iTunes library. Youdo not need to look through folders inside folders. And you have the ability to tag your contents, making it easier to locate required content. Finally you can easily place citations tinot your word profcessing papers without having to leave the program you are working in.
CiteThisForMe: available at www.citethisforme.com. This also allows you to automatically grab bibliographic information right form whatever web page you are on. It easily lets you denote the kind of reference you are grabbing, creates a master list of all of your references, but lets you create individual bibliographic lists, download other lists, and share those lists with a defined group. It can format the reference lists in a wide range of styles.

EasyBib: available at www.easybib.com. This program works with Google Drive, which I have to admit I do not use for myself. In its free version, it allows you to only create reference lists in MLA style, which may not work as well in standard scientific writing, which generally requires Vancouver style references. However, it can be upgraded, for a small fee.
ProQuest Flow: available at www.proquest.com/products-services/flow.html. This is a cloud-based product that “helps researchers better manage citations and full-text documents and gain control over the research workflow.” (As stated on its web-site). You can either automatically enter a citation with a one-click process, or you can manually enter information if necessary. This program has a huge database of reference styles.

References

1.       Require your students to use citation software. Online Cl@ssroom 2014;14(9),p4,8

Tuesday, September 16, 2014

CARE Guidelines

In my last blog post I discussed writing case reports. I noted at the end that there was new guideline for preparing case reports, known as CARE (http://www.care-statement.org/#), which my friend an colleague Dr. Karen Boulanger had written about in her most recent publication (1). Templates for CARE can be downloaded from the CARE website, at http://www.care-statement.org/case-report-writing-template.html

The elements which should be included in writing a case report are as follows:

Title: The guidelines now recommend the words “Case Report” be in the title. This is actually counter to recommendations I have made in the past, where it was felt that since a paper would likely be put in a section of the journal devoted to case reports it was no longer necessary to list it as part of the title. This is a change, but it clarifies what the paper is about.
Abstract: Typically, this uses a structured format, but some journals have moved away from that. In the abstract, you should include the reason for the repot, presenting concerns of the patient, diagnosis, intervention and outcomes.

Key Words: These should be MeSH terms, so select carefully.
Introduction: Provide background for your case and why it is important.

Presenting Concerns: Why did the patient seek care? Provide historical information about the patient.
Clinical Findings: Provide only those findings which are relevant to the case. No need to provide ling lists of normal findings. Be sure to support your diagnosis with the findings.

Timeline: What was the course of care. A table or figure can help illustrate this quite well.
Diagnostic Focus and Assessment: Summarize your diagnostic finding and your clinical reasoning arising from those findings.

Therapeutic Focus and Assessment: Discuss your treatment plan and how it was administered.
Follow-up and Outcomes: Summarize the clinical course of the case. How did the patient respond to care? What was the final outcome?

Discussion: What does this all mean? What was learned as a result of publishing the report? What gap in the literature was filled? What other interpretations of the results might be considered? What limitations exist?
Patient Perspective: This is a new part of the paper. Where possible and appropriate, the patient should provide a brief narrative of their case to accompany the paper.

Informed Consent: The patient should provide consent and permission for the paper
This is all pretty much what traditionally has been seen in case reports, but this codifies the format, making it easier to know how to organize information and construct a logical flow from it. Please use!

 References

1.       Munk N, Boulanger K. ASdaptation of the CARE guidelines for therapeutic massage and bodywork: efforts to improve the impact of case reports. Int J Ther Massage Bodywork 2014;7:32040

Monday, September 8, 2014

How to Prepare a Case Report

In the past couple of weeks I have had an opportunity to work with several faculty members who were interested in preparing case reports. It was my honor to do so. It led me to consider offering up a few thoughts on how to get them ready for publication.

The easiest way to prep a case report involves, really, just two issues: one is to have the case records at hand, and the second is to know the general template for putting that information into readable from. Assuming that you have the records available, I will focus on the second item here.
The general format or template for a case reports is: Structured Abstract, Introduction, Case Report, Discussion, Conclusion, References.

Structured Abstract: Really, this should be prepared last, after the paper is completed. But when you are ready, most journals require a structured abstract with specific subheadings: Objective (why are you writing the paper?); Clinical Features (what were the features the patient had when he or she came for care, leading you to your diagnosis?); Intervention and Outcome (what did you do and how did the patient respond?); Conclusion (what do you conclude for the above?). And you have to do all of this in 250 words or less.
Introduction: This usually will provide some background information on the condition of interest, as well as provide some context for the educational value of the case. Put it this way: what is unusual here, what gap in the literature will be filled by publishing the case?

Case Report: Well, this is the report of the case, of course. It needs to provide the reader only the essential information: on diagnosis and tests run, on treatment and on outcome. The reader should be able to confirm that you made a correct diagnosis, and they should be able to understand the intricacies of your treatment, and they should be able to assess the outcome instruments you used for monitoring progress.
Discussion: This explains the educational value of the paper. What did we learn here? How does what we learned here fit into the larger body of information available about this condition or topic? The primary function of a case report is to educate the reader, to help them learn something. That should be the focus of the paper- so, you may focus on teaching about the condition, or perhaps its management or perhaps something else.

Conclusion: This is really just a recapitulation of what came before. It should not offer any speculation, but may suggest directions for future research based on what you found.
References: Of course, references are important since they provide the foundation for the importance of your case.

I recommend that you pick up a case report or two from a chiropractic journal and look to see how well they fit into this template. Knowing these components can ease the fear you might feel in considering writing something for publication.
As I prepared to post this, I received a note from Dr. Karen Boulanger, about a new paper she co-wrote related to preparing case reports. It is excellent and can be accessed at http://ijtmb.org/index.php/ijtmb/article/view/251/303