“CATCH-IT Reports” are Critically Appraised Topics in Communication, Health Informatics, and Technology, discussing recently published ehealth research. We hope these reports will draw attention to important work published in journals, provide a platform for discussion around results and methodological issues in eHealth research, and help to develop a framework for evidence-based eHealth. CATCH-IT Reports arise from “journal club” - like sessions founded in February 2003 by Gunther Eysenbach.

Monday, November 16, 2009

(DRAFT) CATCH-IT Report: Acceptability of a Personally Controlled Health Record in a Community-Based Setting: Implications for Policy and Design

(DRAFT) CATCH-IT Report: Acceptability of a Personally Controlled Health Record in a Community-Based Setting: Implications for Policy and Design

(J Med Internet Res 2009;11(2):e14)

AbstractFull TextSlideshow

Medical records; medical records systems, computerized; personally controlled health records (PCHR); personal health records; electronic health record; human factors; research design; user-centric design; public health informatics

The field of consumer health informatics (CHI) stems from the ideology of empowering consumers whereby CHI innovations have the potential to support knowing participation of patients/consumer in healthcare practices (1), (2). Personally Controlled Health Records (PCHR) being a web-based collection of a patient’s medical history can be considered as one such innovation in the field of CHI and is anticipated to result in better self-care, reduced errors and improved health (3). To this end, the paper by Weitzman et al, Acceptability of a Personally Controlled Health Record: Implications for Policy and Design (4)(2) is by far the first published report studying an electronic platform that puts the users in control of their personal health information from an electronic medical record to which they are subscribed. The paper provides an account of the pre-deployment, usability, pilot testing and a full demonstration of a typical PCHR, using Dossia Consortium’s Indivo PCHR as a medium of analysis.

The authors of this paper are pioneers in the field of public and consumer health informatics (5), are affiliated with Harvard School of Public Health and have published numerous papers in peer-reviewed journals. Although this is the first of their papers addressing the PCHR in a community-based setting, it is expected to help determine what changes need to be made and the policies put in place before a widespread adoption of PCHR in a wider setting (6,6).

The purpose of this study was to understand the acceptability, early impacts, policy, and design requirements of PCHRs in a community-based setting.

Weitzman and colleagues (7) describe the intervention as a citizen- or patient-centered health record system that interoperates with but not tethered to a provider system representing a fundamental change from the current approaches to health information management.
Indivo PCHR being an open-course PCHR platform that has served as a model for the proliferation in the PCHR movement as cited in earlier papers by Kenneth Mandl (3), (8), this study aimed as exploring the beliefs and reactions to the Indivo PCHR. The paper therefore had two sets of objectives: primary aim of learning about the acceptability of PCHRS, and barriers and facilitators to its adoption; and the secondary aim of identifying policy and design issues before refining the system for deployment.

The research was a formative evaluation of beliefs, attitudes and preferences involving observational assessments over a two-year period from May/June 2006 to April 2008. Study participants were affiliated with the university health maintenance organization in a community-based setting. More than 300 participants took part in the study involving three phases: (i) pre-deployment (n=20 clinician, administrators, institutional stakeholders; age 35-60 years), (ii) usability testing (n=12 community members) and pilot demonstration (n=40 community members; age 25-65 years), and (iii) full demonstration (n= 250 participants; age 18-83 years; 81 email communications). No description was provided on how the participants were recruited.
The abstract mentions a shared rubric of a priori defined major constructs which may be interpreted as a framework analysis approach to the qualitative study. Whether or not it actually followed the framework analysis methodology is not clearly stated. Also, no reference has been cited with regards to the formal usability protocol.
In terms of the strength of the analyses, the analytic approach section describes the process of independent review of email communication by individual reviewers which was a positive aspect. Moreover, the triangulation of data involving time, space and persons (9) at different stages of the formative evaluation adds to the credibility, reliability and validity of the results in this qualitative study.
However, there lies a concern regarding the predefined themes- awareness of PHRs/PCHRs, privacy of personal health information, and autonomy. One may interpret that the themes were formed as part of a related study done earlier and the same set was applied in the context of this qualitative analysis. How the major constructs emerged and the process of being operationally defined is unclear and needs concrete explanation to make the methodology section transparent.

Of the three preset themes, the level of awareness of PCHRs was found to be low, paired with high levels of expectations and autonomy. Moderate level of privacy concerns were identified with younger users possessing limited understanding of harmful consequences of sharing information on the web. Additionally, barriers and facilitators for adoption of a PCHR seemed to exist at institutional, interpersonal and individual levels.
Based on the STARE-HI (10) recommendations, the results section lacked specific information on outcome data in terms of unexpected events during the study and unexpected observations, if any.
Some very interesting topics such as literacy issues, guidelines on risk and safety mechanisms, creation of family-focused health record, and protocols and models in human subject participation in PCHR evaluations were discussed in the implications for policy and practice.

In qualitative research, much of the analysis begins during data collection (11). In this case, the researchers already had a priori themes but it is not clear as to where the themes originate from and what are the three major codes based upon. Moreover, in the presence of preset themes, the analysis does not discuss at what point the researchers reached data saturation. An appendix providing background reference pieces would suffice to provide context to readers.

The sampling technique used to recruit participants was not stated in the paper. Although the fact that participants were already familiar with and trained in the health field was not a major concern, the inclusion and exclusion criteria would have clarified the study methodologies further.

There was no mention of medico-legal concerns, who owns the records were not brought out by clinicians interviewed! Also, in light of privacy issues, Indivo PCHR being open-source, it would be relevant to consider the long-term implications of Indivo’s relationship with Dossia consortium.

According to Pope et al. (11) the framework approach is recommended for policy-relevant qualitative research. Having a priori defined major codes imply that the study reflected characteristics of a framework analysis, a clear statement as to the approach used is crucial.
This study was a labor-intensive and time-consuming task requiring trained and crucially experienced researchers (12) and is reflected in Table 1. However, providing a figure or table with an overview of the three research activities, summarizing key information such as activity, number of participants, characteristics of participants, questions/instructions to the participants would enable a reader to assess the study’s merit while providing transparency of the research conducted while facilitating future research in the field.

Since the area of innovation studied is relatively unexplored when compared to other PHRs in general, the qualitative approach was a particularly useful means of analyzing and exploring stakeholder reactions to base policy decisions (13).

Despite its limitations, the results and discussions were well-defined and reported but the methodology appeared to be lacking sufficient detail in order to justify the findings alluded to. Overall, the study concept was well-conceived with the exception of few transition gaps between the methodology and results section that ensures a smooth reading. It would be interesting to compare the results with follow-up studies in different settings.

Questions for Authors
· How were the participants recruited? How many participated in focus-groups and one-to-one interview?
· What qualitative approach (ethnography, grounded theory, framework analysis, or any other method) was used?
· How was the coding performed?
· Did the study make use of any computer package to analyze data?
· What potential biases were faced and how were they eliminated?
· How were the sharing of passwords and account information of the participants dealt with in the analysis? What level of privacy education was provided to the participants? What consent choices were offered?
· How many users are represented in the email communications? Did the other users have any technical or other issues?
· Did the IRB approval state how to dispose the research data?
· Why did participants include non-clinical information? Was there a visible privacy policy on the PCHR application?
· Was the individual record encryption both ways: patient-PCHR?

The author would like to thank the members of the CATCH-IT Journal Club from HAD 5726 ‘Design and Evaluation in eHealth Innovation and Information Management’ course at the Department of Health Policy Management and Evaluation (HPME) at University of Toronto for their insightful comments and constructive criticism in the creation of this report.

Multimedia appendix

(1) Eysenbach G. Consumer health informatics. BMJ 2000 Jun 24;320(7251):1713-1716.
(2) Lewis D, Eysenbach G, Kukafka R, Stavri PZ, Jimison H. Consumer Health Informatics- Informing Consumers and Improving Health Care. New York: Springer; 2005.
(3) Mandl KD, Simons WW, Crawford WC, Abbett JM. Indivo: a personally controlled health record for health information exchange and communication. BMC Med.Inform.Decis.Mak. 2007 Sep 12;7:25.
(4) Weitzman ER, Kaci L, Mandl KD. Acceptability of a personally controlled health record in a community-based setting: implications for policy and design. J.Med.Internet Res. 2009 Apr 29;11(2):e14.
(5) Harvard Medical School. Personally Controlled Health Record Infrastructure. 2007; Available at: http://www.pchri.org/2007/pages/organizers. Accessed October 31, 2009.
(6) Children's Hospital Boston. Available at: http://www.childrenshospital.org/newsroom/Site1339/mainpageS1339P1sublevel526.html. Accessed October 31, 2009.
(7) Weitzman ER, Kaci L, Mandl KD. Acceptability of a personally controlled health record in a community-based setting: implications for policy and design. J.Med.Internet Res. 2009 Apr 29;11(2):e14.
(8) Mandl KD, Kohane IS. Tectonic shifts in the health information economy. N.Engl.J.Med. 2008 Apr 17;358(16):1732-1737.
(9) Denzin N editor. Sociological Methods: A Sourcebook.. 5th edition ed.: Aldine Transaction; 2006.
(10) Talmon J, Ammenwerth E, Brender J, de Keizer N, Nykanen P, Rigby M. STARE-HI -Statement on Reporting of Evaluation Studies in Health Informatics. Yearb.Med.Inform. 2009:23-31.
(11) Pope C, Ziebland S, Mays N. Qualitative Research in Health Care- Analysing qualitative data. British Medical Journal 2000 8 January 2000;320:114-115-116.
(12) Dingwall R, Murphy E, Watson P, Greatbatch D, Parker S. Catching goldfish: quality in qualitative research. J.Health Serv.Res.Policy 1998 Jul;3(3):167-172.
(13) Woolf K. Surely this can't be proper research? Experiences of a novice qualitative researcher. The Clinical Teacher 2006 March 2006;3(1):19-22.


  1. Shamsa, you covered all aspects really well. This is a minor point and could be grouped with first ques listed - there is no info as to whether there is cross-over for participants, or if each activity had independent participants, e.g. if someone took part in a focus group, could they also have participated in usability testing, etc.

  2. Hi Shamsa,

    very good draft; however, I am not clear on the following sentence "Weitzman and colleagues (7) describe the intervention as a citizen- or patient-centered health record system that interoperates with but not tethered to a provider system representing a fundamental change from the current approaches to health information management."
    It seems it is a run-on sentence. Also what does the word "tethered" mean?
    Thank you.


  3. Laure, thank you for the suggestion, I'll add it to my questions to authors.

    Marjan, interesting comment. 'Tethered' PHR refers to "a subset of data compiled by a provider, other healthcare entity such as a health plan, or an employer promoting wellness among employees. The individual can access and update the tethered PHR. An untethered PHR is controlled by the individual who signs up for an Internet-based service." (Source: http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_033817.hcsp?dDocName=bok1_033817). Also, you might want to refer to Slide #14 from Gunther's presentation on PHR 2.0 available from http://www.slideshare.net/eysen/eysenbach-phr-20-personal-health-records-20-vancouver