Transvaginal Mesh Case Record Review

Chapter 5 - Review of the Case Records and feedback to the Participants

Introduction

5.1 This chapter considers the methods that the Panel adopted to review the case records for each participant and how we communicated our findings to the participants.

Clinical Proforma

5.2 The Clinical proforma was the last of the templates^[102] that we created for the Review. It was the document that each clinical member of the Panel received and which detailed matters of concern that the participants wished us to address. The form was set out chronologically, starting with consultation pre-surgery, discussion of any conservative treatments, matters relating to consent, the initial surgery, post-surgery and any mesh revision surgery. It mirrored the detail contained in the information gathering form.^[103] The clinical proforma contained only an identifying participant number and CHI^[104] number so that we could cross check that we were considering the correct records for each participant. Participant names or healthcare professional’s names were redacted.

5.3 We found this a useful document as it provided a focus in summarising discussions between me, the administrator and the participants, and the chronology not only mirrored the content of the information gathering form, but also the order in which we received the collated records. Some of the participants sent the Panel a list of specific questions that they wished us to address and these were included in the Clinical proforma, and in the bespoke reports shared with each participant after the Panel review.

5.4 This proforma was sent to the clinicians by the administrator or myself by email, in parallel with the collated records being made available via a secure digitised process. This part of the process worked smoothly.

Collated case records

5.5 Once Clinco had retrieved the case records that had been requested, they put them into a chronology which reflected their treatment journey. As noted earlier, case records were indexed into digitised volumes, of around 375 pages per volume. Once these were complete, Clinco sent them to our administrator via Egress.^[105] The administrator then checked and confirmed receipt of the records to Clinco.

5.6 The Panel had discussed various options for sharing the records amongst ourselves. Due to the large volume of the records, printing these out and posting hard copies to each Panel member would be resource-intensive, both in term of printing out multiple copies, and the expense of securely posting such large files. There was also the matter of confidentiality and heightened risk associated with hard copies being consigned to the post. Hard copies also became outwith the control of the administrator, should any late additions need to be made. We agreed that keeping them in digital format was the best approach and addressed the concerns of managing large paper volumes and matters regarding confidentially. The files were too large to be part of a usual secure attachment so an alternative method had to be found.

5.7 We agreed that using an Electronic Discovery Reference Model (EDRM)^[106] would best suit our requirements. It is a process which allows the gathering, storage and assimilation of data into one accessible digital area. It is a practical choice where large amount of data has to be stored and reviewed. It is also flexible so that the management and protection of data can be refined to suit a specific project.

5.8 For the Case Record Review, the authority, control and management of the data was the sole responsibility of the administrator. Once she received the files from Clinco, she put them on the ERDM system and after checking they were visible and accessible, she facilitated access for the rest of the Panel members. The administrator was the only member of the Panel who could add, remove or revise documents. All documents remained in digital format and could not be downloaded. Like all new processes, it took us a little time to familiarise ourselves with it, but once we did, it was an uncomplicated, practical and successful way to access the case records.

5.9 Each clinical member of the Panel was asked that they review all case records independently and not to discuss them with each other until we met together as a full Panel. One clinician would provide context and a summary prior to the review of every participant’s records. We then worked through the records in the chronology described in the clinical proforma. All clinicians had the opportunity to contribute equally to all the cases that we reviewed. My role during these discussions was as an independent facilitator and advocate for the participant ensuring, to the best of our ability based on the documentation available to us, that we had addressed all the issues that they had raised. Whilst the discussion focused upon the case records, it often extended into other areas and themes and our discussions from these can be found in Part ll of this Report. Using a small handheld dictation machine, our discussions were recorded and transcribed by the administrator and then sent to me.

5.10 It was unsurprising that some of our discussions took three hours and that the transcripts were large documents, containing up to 40 pages. I then read these, formatted them into the chronology in which we considered them and summarised them in a final draft report. These were then returned to the clinicians to review and if they agreed that the report accurately captured the outcomes of the discussions, they were then signed off. Using this format, every case record report for each participant was the result of a unanimous Panel decision. Whilst this usually was preceded by discussion, agreement was usually achieved without too much difficulty. Once the Panel had agreed and signed off a report, it was sent to the participant with an email explaining next steps.

Next steps - the participant receives their report

5.11 Once completed, the administrator emailed the report, password-protected, to the participant. The accompanying email encouraged the participant to take as much time as they needed to read and reflect upon their report. An invitation for a meeting to discuss the report with a clinician from the Panel and myself was offered and it was left to the preference of the participant whether or not they chose to avail themselves of this. They were also welcome to have someone in attendance with them as their support/advocate. During these meetings, if it was brought to the Panel’s attention that we had misunderstood a material point, we again reviewed the evidence available to us and took a decision whether or not to amend the report. We did this on two occasions with the amendments appearing as a footnote so that it was clear what had been revised and why it had been revised. Finally, all participants were offered a copy of the case records that had been retrieved by Clinco and reviewed by the Panel. They were able to receive this digitally, or as a hard copy. Both methods were arranged by Clinco and forwarded directly to the participant. Seven participants chose to receive a copy of their case records. Six participants chose to receive their records in hard copy and these were couriered to them and one requested hard copy and digital format. Whilst we recognise that, in some instances, participants may not wish to view their case records, the Panel remain surprised that more participants did not request their case records.

5.12 This completed the review of each participants their case records.

An alternative model

5.13 The Panel believe that our approach to our review of the case records was thorough, comprehensive and successfully met our objectives as set out in the Review’s Terms of Reference. However, the process was time-consuming, and aspects of record retrieval as previously described were inefficient. Again, we acknowledge that this involved a small pilot number of 18 participants. The final chapter of Part l of the report considers some alternative models that have been introduced in other jurisdictions but first we propose below an alternative method to retrieval and collate case records.

Alternative collation of records- Scotland

Short form retrieval

5.14 Since part of our remit was to consider alternatives, the Panel have also explored the option of undertaking a short form alternative to the process that we used in the Case Record Review. This would involve a more focused review of a narrower part of the case records. Whilst it is demonstrably less resource intensive, some of the issues remain since it would be retrospective and address only issues which have been written in the case notes. It does not consider verbal communications nor does it address future care. The question remains if this would be a workable solution as one part of a set of comprehensive measures.

5.15 Clinco assisted us in this exercise by selecting at random one of our existing participants to benchmark this shorter alternative. In this example, the chronology, was reduced from 18 pages to 3½ pages, and the case records from a total of 2,021 pages to 39 pages. The total time Clinco took to produce the documentation, indexed and paginated bundle, imaging schedule and full chronology for the full version took 29.3 hours. The estimated alternative time for the ‘short form’ which contained no index and with pages left in a random order, but including a short form chronology, took about seven hours.

5.16 Whether the less detailed results are worth the time/cost savings remain to be decided. Much of the context of the treatment is lost in the short form, including most of the history, and peripheral patient experience, but information regarding consent, conservative treatments, surgery (including revision surgery) would all be included. It would make the review more cost efficient for a larger number of patients and patients would be supported throughout this process and the peripheral patient experiences could be address through other means. What these could be are discussed in the next chapter.

Subject Access Requests (SAR’s)

5.17 Under the provisions of the General Data Protection Regulation (UK GDPR),^[107] all patients have a right to access their health and care records. Most health boards in Scotland have readily available information online about how to access case records and include a template form to assist with the request.^[108] Whilst they may differ in style and format there are central features to all of them including who may apply: they can be requested by the individual themselves, or someone acting on their behalf.^[109] There is no requirement to provide a reason for the request. The information is normally provided within 30 days of receipt of the request. GDPR and the 2018 Act provides for a number of exceptions^[110] including matters relating to those who lack capacity. Information can be withheld if there is a steadfast reason to believe that receiving case records may cause serious harm to the physical or mental health of the person to whom it applies. A SAR can include, all healthcare records, both from community healthcare (general practice, health visiting, pharmacy etc) or hospital healthcare (outpatient clinics, inpatient stays, emergency attendances and operation notes etc).

5.18 The Panel are of the view that given that each Health Board already has processes in place to receive and process such requests, it may make any future Review process more streamlined. However, what a patient receives will not be indexed or necessarily be in any chronological order. The Panel believe that it is critical to have a process whereby what is requested is what the individual wishes to see, and provides relevance and context to inform what they would like to know. We therefore recommend, that, in conjunction with other initiatives,^[111] the short form retrieval method is adopted.

5.19 The Panel believe that it is critical to have a process whereby what is requested is what the individual wishes to see, and provides relevance and context to what they would like to know. We therefore recommend, that, in conjunction with other initiatives, the short form retrieval method is adopted.