In today’s fast changing world of medicine, it has become imperative that a practicing physician remains absolutely updated with the most recent developments, recommendations and guidelines in his practice area. It is also important that populations expected to be affected by respective treatment guidelines have a participatory say in its formulation.

The Need

Over a period of time the Clinical Practice Guidelines (CPG) have attained a new definition and meaning. The Institute of Medicine, USA in 1990 defined CPG as: Guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. In 2011 they redefined them as, Guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options. The new definition clearly distinguishes Clinical Practice Guidelines from other forms of clinical guidance derived from widely dispartate development processes (e.g., Consensus statements, appropriate use criteria, practice parameters). Although each of the latter also has its own place and significance in today’s clinical practice environs.

Rather than dictating a one-size-fits-all approach to patient care, clinical practice guidelines offer an evaluation of the quality of the relevant scientific literature, and an assessment of the likely benefits and harms of a particular treatment. This information enables health care clinicians to select the best care for a unique patient based on his or her preferences.

It is thus essential that erudite opinion leaders from the respective country identify the gap areas, study the globally available literature, consult and interact with all stake holders to develop Consensus statements, Recommendations and Clinical Practice Guidelines for the benefit of the practicing physician and society at large.

What we do?

We noticed the unmet need and existing gap in the market for medical advisory services in various countries. ACME UK through its Advisory Board helps in structuring, guiding, overseeing and reviewing the recommendations of specially set up Advisory Boards. Advisory boards have been part of the professional landscape for a long time, providing valuable expert opinions on ensuring thorough consensus building, clinical advocacy and claims development.

ACME UK adheres to the principle that CPGs should follow a sound, transparent methodology to translate best evidence into clinical practice for improved patient outcomes.

Our Standards & Norms

ACME UK’s development process adheres to the following global standards and principles:

Institute of Medicine (IOM): Clinical Practice Guidelines We Can Trust. Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs)(www.iom.edu)

Council on Medical Specialty Societies: Principles for the Development of Specialty Society Clinical Guidelines (www.cmss.org)

Council on Medical Specialty Societies: Code for Interactions with Companies (www.cmss.org)

WHO Handbook for Guideline Development

While proceeding with development of CPGs, we adhere to the following globally accepted norms:

Clinical practice guidelines should be developed using rigorous evidence-based methodology with the strength of evidence for each guideline explicitly stated.

Clinical practice guidelines should be feasible, measurable, and achievable.

Clinical practice guidelines, from which quality performance measures will be developed, should be reviewed by representatives of the physicians they will impact.

Clinical performance measures may be developed from clinical practice guidelines and used in quality improvement initiatives. When these performance measures are incorporated into public reporting, accountability, or pay for performance programs, the strength of evidence and magnitude of benefit should be sufficient to justify the burden of implementation.

In the clinical setting, implementation of clinical practice guidelines should be prioritized to those that have the strongest supporting evidence, and the most impact on patient population morbidity and mortality.

Research should be conducted on how to effectively implement clinical practice guidelines, and the impact of their use as quality measures.

Clinical practice guidelines, from which quality performance measures have been developed, should be updated as new evidence is available, and the producers of the performance measures should be notified of the work in progress.

Principles for Development

We follow the eight standards for developing trustworthy guidelines identified by AAFP. The standards reflect best practices across the entire guideline development process, including attention to:

•  Establishing transparency
• Managing conflict of interest
• Guideline development group composition
• Clinical practice guideline systematic review intersection
• Establishing evidence foundations for and rating strength of recommendations
• Articulation of recommendations
• External review
• Updating

For Whom?

Professional, specialty and super specialty medical associations; leading medical schools and research institutions all have a strong desire and responsibility for contributing their bit to development of Clinical Practice Guidelines. Even committed consumer groups today want to be actively associated with guidelines development, as they are the final affected group.

What comes in the way of this noble responsibility is a lack of time, infrastructure, resource and core competence to take the initiative forward. That’s where ACME UK comes in.

We advocate the development of explicit patient-centered clinical practice guidelines which focus on what should be done for patients rather than who should do it. When clinical practice guidelines address the issue of who should provide care, then recommendations for management, consultation, or referral should emphasize appropriate specific competencies rather than a clinician’s specialty designation.

ACME UK participates with other medical organizations, specialty bodies, organisations and institutions in the development of clinical practice guidelines (also known as practice parameters or clinical policies) when appropriate criteria are met. A Memorandum of Understanding (MOU) is developed to guide the process.

ACME UK has developed a CPG Development Manual, based on internationally accepted norms which is followed during the entire process

The Process?

At ACME UK, a dedicated team is constituted, of professionals from the disciplines of medicine, clinical & data researchers, medical writers, graphic designers, etc. to steer the process of development of CPG. The process passes through the following stages:

Identify the unmet needs & finalise the CPG Clinical Topic

The first step is to identify the area/ discipline in which there is an unmet need for development of Clinical Practice Guidelines (CPG) for that particular country; Consensus Statement or Recommendations. This may vary from country to country. This leads to finalisation of the CPG Clinical Topic.

Finalise the End Deliverable

We then finalise the actual topic and subtopics which the end recommendations would cover. These would appear as Title of the CPG and Chapters in the Title.

Constitution of the CAB ( Clinical Advisory Board) or GDG ( Guideline Development Group)

An eminent, erudite, recognised opinion leader of the respective country ( for which the Guidelines are proposed)  is requested to head the group as its Chair cum Editor. ACME UK appoints an independent peer reviewer. In consultation with him the CAB/GDG is constituted. Care is taken to ensure that experts from disciplines are taken based on the Chapters to be finally written as part of the main Title (Recommendations/Guidelines). An allocation, chapter wise is done for each member of the CAB/GDG. At the same time, it is ensured that the CAB/GDG is multidisciplinary and balanced, comprising a variety of methodological experts and clinicians, and even populations expected to be affected by the guideline.

Patient and public involvement is facilitated by including (at least at the time of clinical question formulation and draft CPG review) a current or former patient, and a patient advocate or patient/ consumer organisation representative in the GDG.

Conflict of Interest (COI) Policy and Process

Conflict of Interest Forms are got filled from all members. Prior to selection of the Guideline Development Group (GDG), individuals being considered for membership are asked to declare all interests and activities potentially resulting in COI with development group activity, by written disclosure to those convening the GDG. Strict globally recommended guidelines for COI identification are adhered to.

Identification of Key questions & Issues

A team of designated data researchers does a thorough data search and compilation of the main topics. These are scientifically compiled for presentation to the first meeting of the GDG/CAB. At the first meeting of the GDG/CAB the key questions and issues are identified. Also the end deliverable guidelines/ recommendations are clearly defined and authors allocated from amongst the GDG/CAB for each of these chapters.

Timelines are also finalised for the defined road map for achieving the end deliverable.

Systematic Evidence Review of CPG Clinical Topic

A dedicated project coordinator is appointed for the project. The coordinator shall coordinate with, take advise & guidance from each member of the GDG/CAB. In close coordination with each member of the group, he shall do a systematic literature search on the topic from both the respective country and abroad.

This shall be followed by a critical appraisal of the entire literature. The respective chapter author shall then be provided assistance in writing the chapter. After the first draft is finalised with the chapter author, the same is sent to all members of the GDG/CAB for their feedback and observations. These are obtained in a highly systematic, scientific format. The feedback/ observations are compiled chapter wise and shared with all members of the GDG/CAB. This also enables the chapter author to firm up his conclusions for presentation.

Critical appraisal, conclusions & Recommendations

The final meeting of the GDG/CAB is held to finalise the recommendations.

We include the intent, rationale, and scope in all guidelines. This includes, but may not be limited to the appropriate users of the guideline, and situations in which the guideline should be used. This includes information about appropriate patient populations for the guideline. Key questions that were addressed in the systematic review and any relevant clinical questions related to the key questions are included.

We use a modified GRADE methodology for rating the quality of the evidence, and guiding the strength of recommendations. It is worth noting that moving from examining the evidence to making a recommendation is where much of the disagreement happens in guideline development. Different groups that develop guidelines may disagree on how much weight they give to lower-level evidence; may not fully take into account benefits and harms, costs or burdens; and may give differing emphasis on patient or provider preferences and values. However, all of these factors should be considered when making recommendations

Publication

Upon completion, the guidelines are published as an independent publication.

ACME UK’s Clinical Practice Guideline Manual

ACME UK has developed a Clinical Practice Guideline Development Manual. The manual details the entire procedure for development of guidelines, ethical and COI issues, etc. The manual is presented to each member of the GDG for strict adherence.

The Benefits

Advisory board regardless of the therapeutic area will deliver valuable insights. It has distinct advantages for all stake holders.

ACME UK’s team of professionals have carved a well thought out strategy and objective-driven approach to thought leader engagement. Advisory boards are a fundamental tool to gain insights required to achieve a deep understanding and interpenetration of the various medical benefits for a product from the medical community.

If you are a Medical Body or group interested in developing & disseminating authentic, reliable, latest medical information on any aspect, we help you :

• Have a clear purpose based on the real needs of the medical community
• Invite the right experts
• Focus on synergy
• Assign a great meeting moderator
• Clarify mutual expectations
• Incorporate adult learning principles
• Challenge participants to engage and prepare before the meeting
• Convert meeting results into action steps
• Clearly communicate the meeting objectives and outcomes cross-functionally

If you are an organisation engaged in developing CPG in any country on any aspect, we help you :

• Peer review your entire process set up by you to develop these guidelines
• Review, evaluate and independently analyse your guidelines once the draft is ready
• Give our suggestions for further improvement, modification or changes in your draft backed with strong references and evidence based suggestions
• Accredit your final guidelines after finally reviewing them through our independent Advisory Board