Note that this Protocol should be read in conjunction with the UK Renal Registry’s (RR) Information Production System (RR IPS) that contains the scope and commitment by the UK Renal Registry to the Information Standard.
The unique, open access website www.RareRenal.org carries public information relating to the Renal Association Strategy for Rare Kidney Diseases. (Rare Diseases are defined within Europe as having a prevalence below 1:2000 population.) This includes information about rare kidney diseases written for a lay readership of patients and their carers that is within the scope of the Information Standard (IS), as well as professional information to support and advise clinicians that lies outside that scope. The website displays information about the proceedings of the Rare Disease Groups which includes contact details, invitations to patient or clinician education events, participation in research projects and information about patient support groups and their meetings. The website encourages feedback from users as part of the routine audit of the site.
The Chief Medical Officer’s Report in 2010 emphasised the need for high quality information to be made available to patients with rare diseases. This is confirmed in the day to day experience of patients who are disempowered by poor understanding of their condition especially around the time of diagnosis. It is also acknowledged by clinicians, who may have little knowledge or experience of a given rare disorder and find it difficult to give up-to-date advice in the absence such information.
The website pages therefore address:
1) Patients with rare diseases affecting the kidneys, their carers and family members, particularly parents and guardians of childhood patients. Information specifically written for patients who are in their childhood years may be included where relevant. A Glossary, produced by the RareRenal Editorial Board (EB) provides further explanations of specific medical terms. Patient information includes information about patient support groups, opportunities for research participation, and explains how services for a given condition are commissioned in the UK. Patient stories are included. The information Standard applies to the production of all information for this readership. (A log will be kept which records all products, their status and their purpose.)
2) Clinicians in the UK requiring advanced information about diagnosis, special investigation, treatment, co-morbidity, research activity and how to access tertiary or national clinical opinion within the NHS.
3) Commissioners in the UK by providing guidance and recommended care pathways developed by expert Rare Disease Groups (RDG) that are approved by the Renal Association.
The website allows patients and laity to see information for professionals and vice versa. Therefore the site will make it explicit which pages have been produced for which readership. The clinician to clinician, and clinician to commissioner information is outside the scope of the IS.
It is a requirement that RDGs have a patient representative who has an active role in information production.
Choice of Media Type
The website format was selected to reach a wide audience, throughout the country. Those without internet access may review the site with their clinician or others who have internet access.
Sources of Information
Information is largely provided by Rare Disease Group (RDG) Leads who are specialised clinicians within their field. Though the diseases are rare, these clinicians will have had more exposure than others to patients with such conditions.
Given that the diseases are rare, there is little research available for most conditions. However the RDG leads and colleagues with an interest have contributed to academic literature. Therefore the clinical experts are writing with authority using their own experience and hypotheses. Many RDGs collaborate with colleagues nationally and internationally in conducting research on the data available regarding these rare diseases. Information that is evidence-based is referenced in the text.
Date of Publication
The website was openly available from June 2013 and displays a date stamp on each page. Successive versions of each page show the date of the revision.
Direction to Further Information
Within the website there are clear references regarding other sources of information. These references may include helplines, details of the RDGs, patient support groups and other websites (where these exist in relation to each condition).
Reliance on Information Posted
The content of www.RareRenal.org is provided for information purposes only. Professional advice should be sought before taking, or refraining from taking, any action on the basis of the information supplied or linked to on this site.
Whilst every effort has been made to ensure that such information on the website is accurate, the UK Renal Registry cannot be held responsible for any errors or omissions therein, nor for the consequences of these or for any loss or damage suffered by users of any of the information published or linked to on any of these pages. The UK Renal Registry therefore disclaim all liability and responsibility arising from any reliance placed on such materials by any visitor to the website, or by anyone who may have been informed of any of its contents.
The material displayed on the www.RareRenal.org is provided without any guarantees, conditions or warranties as to its accuracy. To the extent permitted by law, the UK Renal Registry, and third parties connected to them, hereby expressly exclude:
- all conditions, warranties and other terms which might otherwise be implied by statute, common law or the law of equity; and
- any liability for any direct, indirect or consequential loss or damage incurred by any user in connection with the website or in connection with the use, inability to use, or results of the use of the wesbite, any websites linked to it and any materials posted on it, including, without limitation any liability for:
- loss of income or revenue;
- loss of business;
- loss of profits or contracts;
- loss of anticipated savings;
- loss of data;
- loss of goodwill;
- loss of reputation;
- wasted management or office time; and
- for any other loss or damage of any kind, however arising and whether caused by tort (including negligence), breach of contract or otherwise, even if foreseeable.
The governance structure is shown in the figure below.
The Editorial Board (EB) has responsibility for website structure, design and content and the ultimate responsibility for product compliance with Information Standards lies with the Chief Executive of the UK Renal Registry. The EB operates according to the procedures laid down in the Information Standard, by which it ensures that RareRenal.org is an accredited site. It shares responsibility with RaDaR and Patient View (PV) for the interactions between these three sites. That is to say that information referred to in RaDaR and PV is accurately displayed in RareRenal.org.
The EB actively seeks high value external sources of information and obtains agreement to link to or display such information for the RareRenal readership. The EB is responsible for auditing the website, responding to feedback from users and dealing with complaints. The Business Support team of the UKRR, with the support of the EB will conduct annual self-audits of the website. Corrective action must be completed within 28 days of the audit report. The audit report will be made available to the Chief Executive of the UK Renal Registry via Workshare. In the event of a non-conformity the remedial action will be verified by the Head of Programmes of the UK Renal Registry and signed off in the Change Request Log.
The EB is responsible for ensuring that copyright regulation is adhered to, and that a log is kept of all displayed materials and their version numbers and dates. The EB is responsible for obviating any conflict of interest that might arise from publication on the website.
The Editorial Board has the following constitution:
- Chief Executive of the UK Renal Registry
- Head of Programmes of UK Renal Registry
- Medical Editor responsible for the scientific accuracy of content,
- Language Editor responsible for ensuring that information is comprehensible by a lay readership with a reading age of 11 years,
- Project Support Officer for RaDaR and RareRenal.org
- Social media specialist
The training of EB members is logged within HR department of UK Renal Registry.
The training and training requirement of Authors (see below) is logged within the HR department of the UK Renal Registry.
RareRenal.org has its own budget line held within the Rare Disease Strategy/ UK Renal Registry. The EB is free to obtain income from charitable sources and educational grants from industry for the purpose of developing and maintaining the site and its infrastructure.
Some of the work of the Board comes from the voluntary sector, but operational management, web design, and Linguistic Editor provision will be professional.
Potential Conflicts of Interest
The policy for handling potential conflicts of interest is set out in the RA PIS. In particular members of Rare Disease Groups are required to disclose potential conflicts, the disclosures being published on RareRenal.org.
Core subject matter is dictated by the portfolio of Rare Disease Groups (RDGs) and their domain of expertise. This expertise includes patient expertise by design. Patient representatives are full members of their RDG. This is integral to the approval of the RDG under the terms of the Renal Association.
Additional material can be selected and commissioned by the EB, particularly in the light of feedback from users, the UK Renal Registry and the Renal Association. The EB sets out guidance on the layout and format for clinical information. An example is “Writing for Rarerenal.org” v2013 appended to this Protocol (appendix 1).
Authors producing patient information on behalf of a Rare Disease Group have the honorary title of Expert Sub-editor. Authors may be professional clinicians, patients, or medical writers employed by the RDG or a patient support organisation. This will help to fully acknowledge their responsibility within the role. For doctors, it can be used in appraisal and re-validation processes.
The peer review of materials that are used as the basis for information for patients is largely addressed by the fact that the RDGs include practicing clinicians, nationally regarded for their expertise in the subject being addressed. That is to say that the skills inherent in the constitution of the RDG is such that opinion and evidence will reflect the pooled knowledge of the leading clinicians and clinical scientists in the field. The design of the website allows raw evidence identified by the RDG to be accessed by html. This is equally available for the patient reader as for the clinician or commissioner.
Authors are invited to participate in training either organised through the UK Renal Registry or externally. A record of training is maintained by the Operational Management Board.
Authors are required to notify any conflict of interest regarding publication to the Editorial Board. This is especially important if the author is funded by a pharmaceutical company or a health lobbying organisation. See Conflicts of interest above.
RDGs, through their Expert Sub-editor, are responsible for providing the first draft of clinical information (version 1, V1) according to the guidance issued. The draft is then revised as necessary by the Language Editor V2, and forwarded to the Medical Editor to check that the clinical and scientific content has been retained. If there is doubt, the Medical and Language editors collaborate to resolve both requirements. Once agreed, V3, the version is returned to the Expert Sub-editor and RDG Coordinator for approval and signed off. If the either identifies errors of fact they notify the Medical Editor for resolution. Any changes other than minor ones require the process to be re-run (V1a, V2a etc). Once agreement is reached the version V4 is dated and displayed.
RDGs can initiate up-dates to the clinical information pages at any time. However, the EB will notify the RDG when the information is due to be revisited, and a revised version is to be in place no longer than 3 years from the date of publication. All versions will be logged and past versions archived.
Auditing patient information
The Editorial Board is responsible for auditing material produced for patients and carers. The Board undertakes to select items for auditing, and will cover approximately 10% of all the information generated by the RDGs. It will not audit linked information from external sources.
The in-scope pages will be reviewed annually. A Product Gap Analysis will be undertaken every three years unless there is a major re-write of any in-socpe pages in the meantime. With regard to the Patient readership, there are two high level outcomes that can be tested: change in knowledge, and change in patient empowerment. These are more important than presentational or aesthetic quality measures. Audit therefore focuses on assessing these outcomes.
Audit will use the following:
- A questionnaire that will be applied to (i) laity who have no experience of kidney disease, (ii) the same questionnaire applied to kidney patients, (iii) the same questionnaire applied to the target patient or carer group. This will serve as a test of knowledge gained.
- Commissioned qualitative research in to the impact of the information gained on the empowerment of patients and to their experiences within the National Health Service.
- Review by the Editorial Board of all complaints or supportive comments logged by the RareRenal.org administrator or editor.
- Evidence logs (created and held by RDGs) can be requested and forwarded to any individual or group as required.
As experience in the use of the Questionnaire accumulates, an analysis will be undertaken to see if a bench mark level of quality can be identified and applied to draft information prior to release; that is to say prospective quality assurance prior to publication.
Illustrations and their permission
Illustrations are used on the site to explain biomedical information as well as to convey general interest. The EB has the responsibility of ensuring that illustrations have the relevant permission from the owners or of individuals shown in the illustration.
Linkage to external websites
RareRenal.org is part of a growing movement to provide better information to patients and clinicians. It is wasteful to produce information if good products are already available. Therefore RareRenal.org provides links to external sites. This requires a formal selection process by the EB that takes into account, medical and scientific accuracy of the information, readability, appropriateness for a UK readership, and permissions. The EB will be advised by the relevant RDG but is finally responsible for monitoring the externally linked information and its versions or dates, and removing and replacing links if they are deemed to fall outside the scope of the IS. The content and accuracy of the information on external websites is not monitored by the EB.
Information Standard Compliance
Only the Patient Information pages on RareRenal.org are in-scope for the Information Standard. New products will be proposed by the completion of a new RaDaR Rare Disease Group Application Form. Approval of this application by the RaDaR Operational Management Board will be taken as approval for the product to be commissioned, as detailed in the Rare Disease Group Standard Operating Procedures.
All documentation will be stored in line with the IPS, with the exception of archived versions of RareRenal pages which will be accessible from the admin area in RareRenal.org.