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Development of a Clinical Decision Support System for Living Kidney Donor Assessment Based on National Guidelines

Knight, Simon R. MChir1,2,3; Cao, Khoa N. MBBS (Hons)1,4; South, Matthew PhD5,6; Hayward, Nicki3; Hunter, James P. MD1; Fox, John PhD6,7

doi: 10.1097/TP.0000000000002374
Original Clinical Science—General
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SDC

Background Live donor nephrectomy is an operation that places the donor at risk of complications without the possibility of medical benefit. Rigorous donor selection and assessment is therefore essential to ensure minimization of risk and for this reason robust national guidelines exist. Previous studies have demonstrated poor adherence to donor guidelines.

Methods We developed a clinical decision support system (CDSS), based on national living donor guidelines, to facilitate the identification of contraindications, additional investigations, special considerations, and the decision as to nephrectomy side in potential living donors. The CDSS was then tested with patient data from 45 potential kidney donors.

Results The CDSS comprises 17 core tasks completed by either patient or nurse, and 17 optional tasks that are triggered by certain patient demographics or conditions. Decision rules were able to identify contraindications, additional investigations, special considerations, and predicted operation side in our patient cohort. Seventeen of 45 patients went on to donate a kidney, of whom 7 had major contraindications defined in the national guidelines, many of which were not identified by the clinical team. Only 43% of additional investigations recommended by national guidelines were completed, with the most frequently missed investigations being oral glucose tolerance testing and routine cancer screening.

Conclusions We have demonstrated the feasibility of turning a complex set of national guidelines into an easy-to-use machine-readable CDSS. Comparison with real-world decisions suggests that use of this CDSS may improve compliance with guidelines and informed consent tailored to individual patient risks.

A clinical decision support system, based upon national living donor guidelines, facilitates the identification of contraindications, additional investigations, special considerations, and the decision of nephrectomy side and may improve compliance with guidelines and informed consent tailored to individual living donor risks.

1 Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.

2 Centre for Evidence in Transplantation, Royal College of Surgeons of England, London, United Kingdom.

3 Oxford Transplant Centre, Churchill Hospital, Oxford, United Kingdom.

4 Austin Health, Melbourne, Australia.

5 Oxford Centre for Human Brain Activity, University of Oxford, Oxford, United Kingdom.

6 OpenClinical CIC, Oxford, United Kingdom.

7 Lincoln College, University of Oxford, Oxford, United Kingdom.

Received 22 May 2018. Revision received 13 June 2018.

Accepted 20 June 2018.

This work did not receive funding from any external sources.

J.F. is a shareholder and Chief Scientific Officer of Deontics Ltd., a commercial company that makes use of the technologies described in this paper. He is also a cofounder of OpenClinical CIC. M.S. is a cofounder of both Deontics Ltd and OpenClinical CIC. K.N.C. is a Medical AI advisor for OpenClinical CIC. S.K., J.H., and N.H. have no conflicts of interest in relation to this work.

All authors made a significant contribution to the content of this manuscript, as per ICMJE recommendations. S.R.K. conceived the study idea, participated in study design, provided clinical input to the decision support system (CDSS), coded the CDSS, entered and analyzed patient data and wrote the article. K.N.C. participated in study design, coded the clinical decision support system and reviewed the article. M.S. participated in study design, developed the openclinical.net platform, advised on the technical development of the clinical decision support system, provided the tools required for data analysis and reviewed the article. N.H. provided clinical input to the content of the clinical decision support system and reviewed the article. J.P.H. participated in study design, provided clinical input to the content of the clinical decision support system and reviewed the article. J.F. developed the openclinical.net concept, participated in study design, advised on the technical development of the clinical decision support system and reviewed the article.

Correspondence: Simon R Knight, MChir, Oxford Transplant Centre, Nuffield Department of Surgical Sciences, Churchill Hospital, Old Road, Oxford, OX3 7LE, United Kingdom. (simon.knight@nds.ox.ac.uk).

Supplemental digital content (SDC) is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.transplantjournal.com).

Donation of a kidney by a living donor (LD) represents a useful source of organs for transplantation, providing around 30% of the kidneys transplanted in the UK each year.1 Living donation does, however, present some specific challenges to the transplant team. Donor nephrectomy is a procedure that places the donor at risk of complications with no potential for medical benefit, and therefore brings unique legal, medical, and ethical challenges.2,3 As such, rigorous national and international guidelines have been developed that place donor safety and ethical conditions at the forefront of the assessment process. The process of donor assessment and consent is designed to ensure that the procedure is as safe as possible for the donor, and that the risks of nephrectomy are clearly defined for each individual to allow true informed consent to be obtained.

Living donor guidelines combine ethical, legal, medical, and psychological considerations that all need to be assessed in the potential donor. These may include contraindications to donation as well as standard and additional investigations required in the assessment of risk. Such guidelines can be complex—the most recent version of the British Transplantation Society (BTS) guidelines for LD kidney transplantation are 293 pages in length.4 The complexity of such guidelines can make it difficult for clinical teams to follow guidance or identify all areas of risk for a potential donor. Indeed, a survey of UK transplant centers identified significant variation in practice between centers with many not adhering to established guidelines in terms of donor eligibility or assessment.5 There is also evidence that this difference in adherence translates to variation in the informed consent process.6

There is some evidence from other areas of medicine that clinical decision support systems (CDSS), using digital representations of guidance, can improve the accuracy of decision making and compliance with clinical guidelines. In simple decisions, such as management of elevated cholesterol, such CDSS have demonstrated improved consistency with guideline-recommended treatment while reducing the time and effort required to reach treatment decisions.7 More complex decisions and treatment pathways present a greater a challenge due to the larger number of potentially conflicting decision conditions. However, CDSS have been successfully applied to breast cancer multidisciplinary team (MDT) decisions based on complex guidelines, again demonstrating improved compliance with guidelines when a CDSS is used.8,9 Use of such systems may also facilitate identification of patients eligible for enrolment in clinical trials9 and help patients to make decisions regarding their own care.10

In the field of transplantation, the use of CDSS has been more limited. A recent systematic review identified 10 studies, mainly investigating the role of CDSS in laboratory test requesting, monitoring of laboratory test results and medication administration.11 Clinical input to the decision support system were shown to improve protocol compliance and reduce errors, but no improvements in overall clinical state were documented. No studies investigated the use of CDSS in living organ donors, and none attempted to implement decision systems based upon complex sets of clinical guidelines.

The aim of the present study was to develop a CDSS for the assessment of living kidney donors, incorporating a patient-completed screening questionnaire, nurse assessment and clinical investigations with decisions based upon national guidelines. Retrospective patient data were used to assess the potential impact of implementing such a CDSS in our center.

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MATERIALS AND METHODS

Existing Donor Assessment Pathway

The existing donor assessment pathway at our center takes 3 distinct stages and requires the donor to attend the department on at least 3 separate occasions. The first stage is donor screening, where the potential donor is asked to complete a screening health questionnaire consisting of medical, psychological and social history. A live donor nurse specialist then reviews this questionnaire with the potential donor during an outpatient clinic, identifying any potential contraindications or considerations relevant to donation. Suitable donors then progress to the medical assessment stage, where they are assessed clinically by a surgeon and nephrologist. Investigations including blood tests, urinalysis, ultrasound, CT angiogram and chromium-ethylenediaminetetraacetic acid glomerular filtration rate (GFR) are completed for all patients. For patients with greater than 10% discrepancy in size between the left and right kidney, split function is assessed by mean of a dimercaptosuccinic acid (DMSA) scan. Once all investigations are complete, potential donors are discussed at an MDT meeting, following which informed consent is obtained during a final clinic visit prior to surgery.

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Development of the CDSS

A data collection tool was designed to be completed online by potential donors, using the openclinical.net platform. This tool aims to replace the existing screening questionnaire, collecting demographic data, medical and social history and psychological screening questionnaires. Each set of questions represents a specific “task” assessing a particular area of medical or social history. Additional tasks are activated in real time as a result of data entered; for example, female specific history of pregnancy, preeclampsia and cervical screening in response to selection of female gender. This minimizes question burden by only showing questions relevant to the user on the screen and therefore completing tasks specific to each individual.

Additional modules allow the nurse specialist to validate the patient-entered information and add the results of laboratory and radiological investigations in a structured format. Raw data are processed to calculate useful derived parameters, such as body mass index (BMI), patient-specific GFR thresholds, kidney size discrepancy and clinical scoring systems.

The openclinical.net platform is based on a well-established approach to the design and deployment of CDSS which facilitates the definition of machine-executable versions of clinical practice guidelines.12,13 Guidelines are converted to a series of “decision candidates” against which entered data or derived values can be compared to identify patient-specific arguments pro and con each candidate and recommend clinical decisions. These recommendations are continuously updated in the background of the application as new data are entered. For the purposes of the current study, a digital representation of the BTS Guidelines for Living Donor Kidney Transplantation (4th Edition, March 2018) was created.4

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Decision Categories

Four categories of decision were defined from the guidelines. “Contraindications” identify major and minor contraindications to live kidney donation (Table 1). Major contraindications are defined as those for which the national guidelines actively discourage donation, whereas minor contraindications are those that increase risk but do not necessarily preclude donation in isolation. “Additional investigations” provide recommendations for any investigations over and above the standard donor pathway, such as oral glucose tolerance testing, echocardiogram, cystoscopy or renal biopsy (Table 2). “Special considerations” identify any other considerations unique to that potential donor that need to be taken into consideration during the assessment or consent process, such as the need for an interpreter, requirement for pregnancy counseling, cessation of oral contraception or psychiatric referral (Table 3). “Donation side” uses available anatomical and functional data to recommend the safest kidney (left or right) for donation, with the default being left-sided donation if no contraindications are identified (Table 4).

TABLE 1

TABLE 1

TABLE 2

TABLE 2

TABLE 3

TABLE 3

TABLE 4

TABLE 4

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Assessment of the CDSS

In order to test the guideline against real decisions made by the local MDT, we retrospectively entered the data of 45 consecutive potential live kidney donors who presented to the Oxford Transplant Centre between January and March 2016. All available patient history and investigations were entered via the online forms, and the recommended decisions generated for each of the 4 categories were downloaded. Decisions generated by the CDSS were compared to actual clinical decisions made by the MDT using computer software (pfanalyse).

This retrospective analysis of anonymized data with no resulting alteration to patient care is considered as clinical audit by the NHS research and ethics service, and as such specific ethical approval is not required.

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RESULTS

Development of the CDSS

The screening component of CDSS comprises 17 core tasks that are completed by all donors (Table S1, SDC,http://links.lww.com/TP/B606). In addition, a further 17 tasks are only activated in response to entry of specific user data (medical history, age/gender related screening, social history and previous surgery/hospitalization). The screening survey takes around 10 to 15 minutes to complete in the absence of a complicated medical history.

The nurse review component comprises 2 tasks; a review of the medical and social history, and the “red-flag” questionnaire from the ELPAT live donor psychological assessment tool to identify specific social, legal, or psychological concerns regarding donation.14

The laboratory and radiological investigations component comprises 3 core tasks to collate results of routine investigations; blood tests and urinalysis, CT angiogram, and GFR measurement. A further optional task collects results of split-function assessment where the size discrepancy between the kidneys is greater than 10%.

Once complete, decisions are provided in the 4 categories defined above: contraindications, further investigation, special considerations and donation side. Example tasks and decision candidates are illustrated in Figure 1.

FIGURE 1

FIGURE 1

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Comparison of Decision Recommendations With Real Patient Episodes

Of the 45 consecutive patients presenting to the unit during the 3-month study period, 17 went on to donate a kidney. The reasons for not proceeding in the remaining 28 patients were: decision to proceed with an alternative live donor (n = 16), recipient received a cadaveric kidney transplant (n = 2), donor deemed medically unfit (n = 7), donor deemed psychiatrically unfit (n = 1) and donor withdrew from assessment (n = 2).

For the 17 patients that went on to donate, the median time from initial presentation to decision to proceed was 132 days (range, 56-626 days). The median time from presentation to donation was 204 days (range, 79-650 days).

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Contraindications

The CDSS identified 15 major contraindications in 13 potential donors. Of those with major contraindications, 7 proceeded to donation. Two patients had a BMI greater than 35 kg/m2 but were deemed by the clinical team to be fit to donate after specific discussion with the patient as to the additional risks posed. Four patients had persistent traces of leucocytes in their urine in the absence of identifiable infection, and no further investigation was undertaken. One patient had a GFR just below the recommended threshold for age. Another had an initial protein:creatinine ratio greater than 50 mg/mmol, which was lower than 50 mg/mmol on 2 repeat samples with a renal biopsy demonstrating thin basement membrane disease.

Of the 7 patients deemed medically unfit to donate, major contraindications were identified in 3 (2 with BMI greater than 35 kg/m2, 1 with a history of breast cancer). A further 3 had contraindications identified on further investigations recommended by the decision tool; one had retroperitoneal fibrosis apparent on CT scan, another had an adrenal nodule requiring investigation, and the final one had significant cardiac disease identified on a myocardial perfusion study. One further patient had a combination of minor contraindications that were deemed too high risk to proceed.

Twenty-four of the 45 patients had minor contraindications to donation. Of the 17 proceeding to donation, nine had minor contraindications. Common minor contraindications included being a current smoker (n = 11), BMI between 30 and 35 kg/m2 (n = 7), persistent microscopic hematuria (n = 6), history of preeclampsia or hypertension (n = 5), and history of psychiatric disease or poor social support (n = 4).

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Additional Investigations

The CDSS recommended additional investigations in 38 of 45 potential donors. Of the 93 additional investigations recommended, 40 (43%) were actually requested and completed. The majority of discrepancies related to the recommendation for oral glucose tolerance testing and the requirement for routine cancer screening tests. National guidelines recommend oral glucose tolerance testing in patients with high fasting blood sugar, BMI greater than 35 kg/m2, of high-risk ethnicity or with a family history of diabetes. Oral glucose tolerance test (OGTT) was only completed in 4 of 23 cases in which it was recommended. Bowel cancer screening is offered to all patients aged 60 to 74 years every 2 years in the United Kingdom. Of those eligible, only 1 of 16 had undertaken recent bowel cancer screening, and this was not requested before donation in the remaining cases. In 2 patients with a history of renal stones, metabolic screen or 24-hour urine collections were not completed as per national guidelines.

Compliance with other investigations was much higher. Patients with hypertension at presentation are recommended to undergo 24-hour blood pressure monitoring, which was undertaken in 9 of 11 patients in which it was recommended. Requirements for up-to-date cervical smears and mammograms in female patients were adhered to in 8 of 10 patients in whom these were required. For patients with persistent microscopic hematuria (n = 6), cystoscopy was requested for 4, and biopsy for 3.

In 2 patients, investigations were undertaken that were not recommended by the CDSS. These were a thrombophilia screen and an echocardiogram, both deemed clinically necessary by the assessing anesthetist.

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Special Considerations

The decision tool identified special considerations in 19 of 45 patients. Referral to a geneticist was recommended in 5 patients due to a history of potentially inheritable kidney disease. Referral was deemed unnecessary by the nephrologist in all cases due to the nature of the history provided and documented, suggesting appropriate management of these patients.

Referral to a psychiatrist was recommended on the basis of clinical history or nurse concern for 5 patients, all of whom underwent further assessment by a psychologist or psychiatrist. One patient of childbearing age indicated the desire for a future pregnancy, and the need for pregnancy counseling was correctly identified. Five patients were correctly identified as taking either the oral contraceptive pill or hormone replacement therapy that needed to be stopped prior to surgery.

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Donation Side

The decision tool recommended a donation side (left or right kidney) if data from a CT angiogram and GFR measurement were provided. Sufficient data were available for a decision for 25 patients; the remaining patients did not proceed far enough through the donation pathway for these investigations to be completed.

The decision tool identified the same donation side as the clinical MDT in 23 of 25 patients. In 2 patients, a significant size discrepancy was identified (>1 cm difference between kidneys). National guidelines recommend assessment of split function with a DMSA scan in these cases, but this was not completed, and the larger kidney was donated in both cases.

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DISCUSSION

This study demonstrates the feasibility of applying a CDSS to a complex, guideline-driven clinical pathway assessing potential live kidney donors. Use of patient- and nurse-entered data in this way has the potential to identify contraindications and necessary additional investigations, improving compliance with guidelines and ultimately reducing donor risk while allowing true informed consent specific to the individual patient.

We have demonstrated that a CDSS has the potential to identify contraindications and investigations defined by guidelines that may be overlooked by the clinical MDT. This is particularly important given the nature of live kidney donation, where the safety of the potential donor is the overriding consideration. Seven of the 17 patients proceeding to donation in the current study had major contraindications as defined by the national guidelines. Although in some of these, adequate consideration was given to the impact of these contraindications and discussion with the patient was documented, there were a number of cases where no patient discussion or MDT consideration was recorded, suggesting that they may not have been identified by the MDT. Although guidelines ultimately advise as to best practice, clinical practice that contradicts best available evidence should be carefully considered, documented, discussed as part of the informed consent process and future guidelines revision. A CDSS, such as the one developed here, will reduce the chance of overlooking specific clinical risks, providing a personalized risk assessment for each individual patient that can be used as an integral part of the informed consent process. Further developed, it may provide an effective feedback loop in advancing guidelines.

Similarly, the CDSS was able to identify a number of additional investigations that were recommended by national guidelines but were not completed. Again, clinical judgment may dictate that in individual cases the risks of further investigation outweigh the need, but the use of such a tool will provide guideline-based recommendations to ensure that these considerations are not overlooked. In particular, it helps to identify where cancer screening is not up-to-date, especially where algorithms are complicated and difficult to remember.

The finding of poor compliance with national guidelines is not unique to our center. A previous study demonstrated a great deal of variability in live kidney donor assessment between UK centers in factors, such as age and BMI thresholds, exclusion on the basis of medical history, and the use of investigations.5 Practice in many centers disagreed with national guidelines, suggesting a role for a CDSS in highlighting evidence-based practice.

The use of a patient- and nurse-completed CDSS may have additional benefits over and above guideline compliance and patient safety. In the current analysis, median time from presentation to decision to proceed with a donor was 132 days, and to donation was 204 days, with a great deal of variation between patients. Although some of this variation was due to recipient factors or use of the Live Donor Kidney Sharing Scheme, in a number of donors prolonged assessment resulted from sequential requesting of investigations or clinical review by other services (eg, psychiatry). Remote entry of data by patients in their home environment, along with earlier identification of necessary investigations, may improve the coordination of investigations and reduce the duration of assessment and number of clinic visits required. This may be important, as the time required for clinic visits has been identified as a potential barrier to the donation process, with improvements in donation rates seen with a 1-stop clinic model.15 Clinical input to the decision support system use may also prevent unsuitable candidates from progressing further down the assessment pathway. All of this has the potential to save patient and nurse time, and ultimately reduce service costs.

There are a number of limitations to the present study. The single-center nature of our analysis means that we are unable to assess the potential impact of this tool in other transplant centers, where compliance with guidelines may differ. Although retrospective analysis of past decisions suggests some room for improvement, we were unable to establish the true impact of a CDSS used in a prospective setting. Previous studies using CDSS for more straightforward clinical decisions have suggested improved compliance with published guidance when the CDSS is used at the point of decision making. A systematic review of studies reporting the use of CDSS in a number of different settings (drug prescribing, reminders, diagnostics and disease management) identified some evidence for improved practitioner compliance, although very few trials documented improved patient outcomes as a result.16 Similar improvements in compliance have been demonstrated in the more complex setting of cancer treatment decisions,8 and in reducing unnecessary investigation in preoperative assessment.17

Successful use of a CDSS relies on clinicians acting upon the clinical decisions provided by the system. This will only happen if the CDSS correctly reflects clinical practice guidelines, and if clinicians believe in the recommendations produced in such guidelines. Good quality guidelines recommend practice based upon the best available evidence via a robust guideline development process. Recent work has demonstrated that the quality of international guidelines in renal transplantation is variable, with guidelines lacking in robust developmental methodology which may have an impact on their uptake in real clinical practice.18 It is therefore important that clinical decisions do not just rely on guideline-based CDSS, but also take into account local practice and clinical experience as part of the live donor MDT process. However, a CDSS, such as the one presented here, can be adapted to local protocols and practice, which may reduce the risk of noncompliance with recommendations when evidence is lacking or of poor quality.

The CDSS developed in this study relies in part on data entry by patients, replacing the use of an existing screening questionnaire. Many transplant centers use a paper-based or online screening questionnaire to identify basic demographic, medical, and social data and to rapidly screen out unsuitable donors. Use of this data may speed up the assessment process but will still require verification by a healthcare professional to ensure accuracy before a final decision can be made. Completion of the patient tasks in the current CDSS takes less than 15 minutes, making it feasible for the majority of patients. Further refinement by populating patient demographics and investigation results directly from the electronic health record will reduce patient and nurse time further and help to prevent transcription errors. The ability to save the form to return to at a later date would also enhance the patient experience. Future incorporation of tools that allow calculation of patient-specific risk of outcomes, such as end-stage renal disease, may further enhance the ability of a CDSS to assist in patient-tailored informed consent.19

In summary, we have demonstrated the feasibility of turning a complex set of clinical practice guidelines for the assessment of potential live donors into a machine-executable data and decision making model. This system is able to accurately identify contraindications, investigations and the most suitable procedure based upon a combination of patient- and nurse-entered data and has the potential to improve evidence-based clinical decision making and patient-specific informed consent. Planned future work will develop this into a patient-facing system and assess the potential impact of this tool in the prospective setting, assessing external validity in other transplant centers.

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REFERENCES

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