Despite the number of potential problems specific to ePHRs in mental health - and the past failings of other ePHRs such as Health Space - very few controlled studies exist in the literature. This was noted in Henderson and Laugharne's review [
32], which identified no randomised controlled trials concerning patient-held records in mental health, in spite of considerable contemporary approval. Despite patient-held records being in use for those with mental ill health, there was no acceptable evidence which could assess the benefits or harms. Since this review, only two RCTs have been published but neither of these studies used an electronic record. Warner, King, Blizard, McClenahan and Tang conducted a 12-month cluster-randomised controlled trial in the UK using a paper-based patient held record, and found that there were no significant effects in the experimental group on symptom intensity, satisfaction with services or hospital admissions [
33]. Furthermore these authors found that the use of the shared care record was low amongst both professionals and patients. The second RCT found better uptake of the UK-trialled (and again paper-based) patient held record, but replicated Warner et al. [
33] in finding no significant differences between groups on measures of symptoms, satisfaction or use of services [
34].
The lack of positive (or detrimental) effects may be due to a number of reasons. Both studies may have missed important effects due to the high attrition rates [
35]. For example, in Warner et al.'s study 56% of the 90 participants randomised to PHR did not use it at all and were therefore deemed not to benefit from it [
33]. Second, the outcome measures might not have been appropriate to identify the costs and benefits. Essex, Doig and Renshaw [
19] showed that patient-held shared care records were acceptable to those with severe mental illness and improved autonomy, effectiveness of shared care, and communication with clinicians; none of these outcomes were assessed in either of the RCTs. In their review of patient held records in mental health services, Laugharne and Stafford [
36] also discovered that patients generally found their notes useful, informative and felt they increased their autonomy. Additionally the authors note that there may be a positive impact on treatment adherence, although they acknowledge the need for a more stringent evaluation of all of these effects [
36]. A final explanation for the null results of previous RCTs might be that the patient-held records did not consist of the necessary elements needed to improve patient outcomes. A paper version of the PHR was investigated in Stafford and Laugharne's [
37] study, in which a patient-held care booklet was provided to long-term mental health service users including information on medications, contact numbers and notes. They found that the vast majority of those in the study viewed the booklet as useful and informative, with participants frequently citing the most useful information as telephone numbers and medication. Both of these were omitted from Warner et al.'s intervention [
33]. Perhaps the most encouraging aspect of Stafford and Laugharne's design [
37] is that a follow-up study five years later demonstrated that nearly 65% of those interviewed were still using the shared care record, showing naturalistic sustainability [
38].
The potential benefits of ePHRs give good reason to pursue their design and implementation. None of the obstacles mentioned above such as computer literacy or issues of confidence are insurmountable; rather, they serve to illustrate that there are a number of issues which must be addressed before implementing ePHRs in the field of mental health. Little experimental rigour has been applied when investigating whether ePHRs will be acceptable and useful to both patient and clinician. There are a small number of naturalistic studies driving the implementation of ePHRs in mental health and although they are encouraging, the results must be viewed as anecdotal.