Development of practice guidelines for hemodialysis in Egypt.

Although hemodialysis is the main modaility of treatment of end-stage renal disease, no practice guidelines are available in Egypt. Applying international guidelines for hemodialysis would not be suitable or feasible, because of different health system and lack of resources. The aim of this project was the development of evidence- and consensus-based clinical practice guidelines for hemodialysis in Egypt. The Egyptian guidelines were adopted from the standards developed by The College of Physicians and Surgeons of Alberta (Canada), The National Kidney Foundation (USA), The Clinical Standards Board for Scotland (Scotland), and The College of Physicians and Surgeons of Ontario (Canada). In addition, the guidelines published in Oxford Handbook of Dialysis were reviewed. Thereafter, a panel of Egyptian experts in the field of nephrology and hemodialysis was selected and invited to participate in this project. The Delphi technique was applied to build up the consensus among the experts on the formulated guidelines. The final version of the Egyptian Hemodialysis Practice Guidelines included five main sections; personnel, patient care practices, infection prevention and control, facility, and documentation/records. A consensus on practice guidelines for hemodialysis has been successfully produced and is supported by levels of evidence. The 12 Egyptian experts who participated in the Delphi technique and the reviewers assured the completeness and acceptability of the developed practice guidelines. Also, including experts from the university hospitals together with the Directorates of Cairo and Giza Health Affairs of the Egyptian Ministry of Health (MOH) avoided conflicts between clinical recommendations and feasible application in the MOH hemodialysis facilities.

Introduction

End-stage renal disease (ESRD) is one of the main health problems in Egypt. Currently, hemodialysis represents the main mode for treatment of chronic kidney disease stage 5 (CKD5), previously called ESRD or chronic renal failure.[1]

In Egypt, the estimated annual incidence of ESRD is around 74 per million and the total prevalence of patients on dialysis is 264 per million.[2] Hemodialysis centers in Egypt exist in governmental, military, and university hospitals as well in the private sector. The average cost of the hemodialysis session ranges from US $16 in governmental hospitals to around US $32 in some private centers. The main hemodialysis regimen adopted in Egypt is three times per week. Most Egyptian centers are equipped with machines with controlled ultrafiltration and synthetic membranes. Many centers use bicarbonate buffer and high flux dialysers although they are not universally applied.[1] The hemodialysis centers, whether private or governmental, are under supervision by the Egyptian Ministry of Health (MOH). However, no Egyptian guidelines or approved guidelines to standardize the practice of hemodialysis are implemented in Egypt. Therefore, hemodialysis is not uniformly practiced across the different centers in Egypt. Adding to this, the practice of hemodialysis in some university centers; considered the highest level of care provision, showed no more than partial compliance with the international guidelines.[3]

There is sufficient evidence that implementation of quality management in the health sector will reduce the cost and provide higher quality. It is imperative to be understood that quality assessment and improvement is the way of the future in the healthcare industry.[45] Quality used to be defined objectively as compliance with, or adherence to standards. It is assumed that quality can be adequately, if not completely, measured once healthcare professionals define the standards of care under which they can comfortably practice. Acceptable compliance with standards is now the basis for granting healthcare organizations licensure/accreditation.[4]

In the United States, the National Kidney Foundation Dialysis Outcome Quality Initiative (NKF-DOQI) selected some aspects of the management of ESRD and developed, to date, 13 practice guidelines including vascular access for hemodialysis patients; treatment of anemia for patients with chronic renal failure; adequacy of hemodialysis; and adequacy of peritoneal dialysis.[6] Other organizations have established practice guidelines for the management of ESRD. For example, the Canadian Society of Nephrology guidelines selected some areas included in NKF-DOQI guidelines and added other not directly addressed by NKF-DOQI which is the management of patients with chronic renal failure before dialysis, particularly with respect to timing of initiation of dialysis.[7] The European Renal Association-European Dialysis and Transplant Association also added some guidelines in respect to water treatment and biocompatibility.[8]

The National Program of Accreditation in Egypt has established some standards for certain clinical areas in hospital services including surgery, anesthesia but has not yet established standards for hemodialysis.

The objective of the study was to develop practice guidelines for hemodialysis in Egypt and developing countries.

Methods

Research setting

The development of the Egyptian Haemodialysis Practice Guidelines entailed the participation of experts in Nephrology and Healthcare Quality Management from Cairo, Giza, and Minia governorates.

Duration and time

The duration of the study was 12 months, from April 16, 2005 to April 15, 2006.

Research methodology

This study is considered one of the health system researches. The study was carried out in two phases [Figure 1]:

Figure 1

Steps of developing the hemodialysis guidelines in the current research

Phase I

In this phase, preliminary quality standards were formulated through:

a) Review of literature to collect the quality standards that have already been implemented in different countries including NKF-DOQI,[9] The Clinical Standards for Adult Renal Services in Scotland,[10] Clinical Practice Parameters and Facility Standards for Hemodialysis by the College of Physicians and Surgeons of Ontario,[11] and Guidelines published in Oxford Handbook of Dialysis.[12]

The above-mentioned sets of standards combine both evidence-based standards and other opinion-based standards. Example of evidence-based guideline is the regular measurement of the delivered dose of hemodialysis and the method of its measurement using Kt/V. Other guidelines are opinion based such as examination of the site of the fistula for signs of infection. The level of evidence was examined through systemic reviewing of related articles keeping the consensus opinion for practices having limited researches.

b) A preliminary version of the Egyptian practice guidelines for hemodialysis was formulated with the contribution of an expert of nephrology.

Phase II

The Delphi technique was applied to build up a consensus among the experts on the preliminary version of the formulated practice guidelines.[13] This consensus building technique among the Egyptian experts has the objective to ensure applicability of the formulated guidelines in the Egyptian practice. The Delphi technique is a structured interactive method involving repetitive administration of anonymous questionnaires, usually across two or three postal rounds. Face-to-face meetings are not usually a feature. The main stages include: identifying a research problem, developing questionnaire statements to rate, selecting appropriate panellists, conducting anonymous iterative postal questionnaire rounds, feeding back results (statistical, qualitative, or both) between rounds, and summarizing and feeding back the findings. The approach enables a large group to be consulted from a geographically dispersed population.

The technique was applied to 12 experts from different public universities, MOH, and other health care facilities, including private sector.

The selection of the experts was done after a meeting attended by the Project Team, Professor of Nephrology and representative of the Department of Nephrology in Giza Governorate (MOH). The selection of the experts was based on experience, high educational background, and to cover diverse geographical areas. The objective of this meeting was to ensure the selection and participation of nephrologists from different health sectors in Egypt.

The first version of the formulated practice guidelines was delivered to the Egyptian experts after explaining the aim and methodology of the study (first round). After 2–3 weeks, the responses were collected and analysed. Thereafter, the areas of disagreement were identified and highlighted. The second version of the guidelines was delivered to the same experts of the first round after clearing up the areas of disagreement and considering the different recommendations of the panel experts regarding them (second round). After 2–3 weeks, the responses were collected and analysed to formulate the third version of the practice guidelines. Thereafter, a meeting was organized and four experts were invited to review the third version in order to reach a final format for the practice guidelines. The four experts included two who previously participated in the first and the second rounds of the Delphi technique and two new experts; the director of the hemodialysis center in a university hospital and the supervisor on hemodialysis centers in Cairo. After the meeting, the final version of the Egyptian Hemodialysis Practice Guidelines was formulated. The final version was reviewed by a Professor of Nephrology in Ain Shams University. Thereafter, the reviewed version was delivered to Professor of Nephrology in Cairo University and Chair of the Clinical Practice Guidelines Committee—The International Society of Nephrology for final revision and approval.

Results

The final version of the Egyptian Hemodialysis Practice Guidelines included five main sections; (1) personnel, (2) patient care practices, (3) infection prevention and control, (4) facility, and (5) documentation/records (Appendix).

These formulated guidelines are prepared in nine pages. The personnel section included the staffing pattern and their qualifications. Patient care practices included the writing order for hemodialysis, pre-dialysis preparation, dialysis process, and care between dialysis sessions. Infection prevention and control section covered the different preventive measures for the patients, medical staff, reprocessing, sterilization, and disinfection for equipments and surfaces as well the housekeeping and waste management measures. The facility guidelines included the physical standards as well the administrative standards. The last section of the guidelines consisted of the documentation and records maintaining.

Discussion

Healthcare facilities are seeking nowadays to develop practice guidelines for the sake of improving healthcare services. In the healthcare sector in Egypt, trials for establishing guidelines have been lead by the MOH.[14]

Although hemodialysis is often used for treatment of ESRD, no practice guidelines are available in Egypt. Worldwide, international organizations set some guidelines like the National Kidney Foundation, which published guidelines concerning the adequacy of hemodialysis, adequacy of peritoneal dialysis, treatment of anemia in chronic renal failure patients, and vascular access.[9] Other individual institutions developed their own guidelines for hemodialysis, which differ according to the accreditation requirements, or the institution administration policy. Almost all the guidelines adopted followed the international guidelines for areas related to hemodialysis such as the infection control and guidelines published by the National Kidney Foundation.

Applying international guidelines for hemodialysis in Egypt would not be suitable or feasible, because of different health system and lack of resources. The main aim of this project was the development of evidence- and consensus-based clinical practice guidelines for hemodialysis in Egypt.

Clinical practice guidelines often grade the “strength” of their recommendations according to the robustness of the supporting research evidence.[15]

Accordingly, we reviewed five practice guidelines from four developed countries to formulate the first set of the Egyptian hemodialysis practice guidelines. Thus, the first version of the Egyptian guidelines was not identical to any of the reviewed practice guidelines, and rather included all controversial issues.

Using the Delphi technique, an exercise was undertaken to ascertain whether a consensus on general protocol for hemodialysis practice could be reached among Egyptian experts. The main problem at this stage was the selection of the Egyptian experts. Currently, Egypt has 17 medical schools together with specialized medical institutes. Selection of the Egyptian experts was a tiresome job. We decided to include consultants from all health sectors in Egypt rather than including only university professors or specialized institutes consultants. Healthcare in Egypt is offered through different sectors (e.g., general public hospitals, specialized public hospitals, health insurance organization, university hospitals, specialized institutes hospitals, police hospitals, and private hospitals), thus it was recommendable to include at least an expert from every sector. We also included an expert from the Directorate of Giza Health Affairs, to be sure that the practice guidelines will be acceptable and recommendable by stakeholders in the Egyptian MOH.

In general, a panel of 12 experts to build a consensus on national practice guidelines is more or less enough. Previously, the Surviving Sepsis Campaign included critical care and infectious disease experts representing 11 international organizations to develop management guidelines for severe sepsis and septic shock.[16]

One round was not enough to develop the Egyptian hemodialysis guidelines, but a second round was conducted on conflicting issues and detailed explanation was given regarding these issues to all experts, including the different American and European recommendations.

The developed practice guidelines after the two rounds were reviewed in a meeting, which included two university professors and two experts from the Directorates of Cairo and Giza Health Affairs. This meeting aimed to ensure the completeness of and acceptability to the practice guidelines, especially that two of the four participants were not included in the Delphi technique. These two new participants were the director of the hemodialysis unit in a university hospital and the supervisor on hemodialysis centers in Cairo governorate, to avoid conflicts between clinical recommendations and feasible application in the MOH hemodialysis facilities.

An example of a conflicting issue was the frequency of measuring Kt/V. Although all international guidelines recommended its measurement every month, our guidelines recommended its measurement, after the meeting, every 3 months, because of its high cost. We referred in this case to the practice guidelines published in Oxford Handbook of Dialysis (2004).[12]

The President of the National Kidney Foundation, a branch of the Egyptian Society of Nephrology, reviewed the final developed practice guidelines. Previously, the Egyptian Society of Nephrology and Transplantation developed management guidelines for hemodialysis, especially concerning the personnel item.

The revised guidelines were reviewed again by the Chair of the Clinical Practice Guidelines Committee (The International Society of Nephrology), who is also the Past-President of the Egyptian Society of Nephrology and Professor of Nephrology at Cairo University, to ensure compliance with the international guidelines and appropriateness for application in Egypt.

According to basic concept of evidence based-medicine, half of all we are taught will in 10 years show to be wrong. Thus, the developed Egyptian Hemodialysis Practice Guidelines should be reviewed and updated regularly by the MOH and the Egyptian Society of Nephrology and Transplantation.

The process of reviewing the published guidelines and quality standards in hemodialysis units tried to include multiple sources to avoid monopoly as well to broaden the options. However, one aspect that has been curiously looked for is the nonclinical administrative and facility quality standards applicable in the hemodialysis centers. This aspect is often unclear or improper in the common organizations delivering hemodialysis in Egypt. Although few published guidelines were used as a basis for this work, yet most of the published guidelines in this field agree with their recommendations and those used in this research are not by any means superior but more or less covering some missing aspects in the Egyptian practice such as the administrative and facility organization.

The present study is an initial step in preparing a set of Guidelines for Hemodialysis that are applicable for the Egyptian practice to cover most of the areas in any hemodialysis center including the personnel and practice. A complementary part for this study is to validate the selected standards by checking the baseline compliance of these guidelines in some hemodialysis centers and hence gives an idea on the gaps and the difference in practices which will evidently determine the further integration of these standards in the regular practice. It will highlight the necessary training areas as well the baseline data after which monitoring will be carried out.

Recommendations

These formulated guidelines were communicated to the quality directorate in the MOH in Egypt. However, the implementation of such guidelines is, till the date of submitting this manuscript, in its first evolutionary steps and depending mainly on individual efforts. Accordingly, the following is recommended to ensure wide application of such standards:

The formulated practice guidelines for hemodialysis should be distributed to all hemodialysis facilities in Egypt. It will be advisable to print the Egyptian hemodialysis guidelines as a small handbook, which could be delivered to all healthcare workers working in hemodialysis facilities.

Organize 1-day workshops for hemodialysis consultants and directors of hemodialysis facilities to orient them with all items of the developed practice guidelines. Attendants should be from both public and private sectors.

The developed practice guidelines should be reviewed and updated, if needed, yearly. The Egyptian Society of Nephrology and Transplantation could take care of this scientific task.