Expert Consultation on Adapting WHO Guidelines Processes used for national adaptation of WHO HIV and Tuberculosis guidelines Mohammad W.Godah, MD, MPH Expert Consultation on Adapting WHO Guidelines organized by AUB GRADE Center Beirut, Lebanon 30-31 May 2016

Objective The objective of this study was to systematically document and evaluate the reporting of the processes used for national adaptation of the WHO guidelines for HIV and Tuberculosis

Methods We selected relevant documents describing HIV and TB national adapted guidelines from three online databases/repositories: The USAID AIDSTAR-One National Treatment Database; The AIDSspace Guideline Repository ; and WHO Database of national HIV and TB guidelines, 2005-2011.

Methods We reviewed the selected documents, abstracted relevant characteristics; and assessed the rigor and the quality of any reported adaptation methodology using a 23-step scale based on the ADAPTE document as benchmark.

Findings - Out of 354 guidelines assessed, 170 (48%) were eligible. - We excluded the remaining 184 guidelines for the following reasons: not published in one of the considered languages (n=28); not based on a WHO guideline (n=75);

Findings not based on the most up-to-date version of the guideline (n=76); and unavailability of the full text of the guideline (n=5).

Findings Only 32 (19%) reported any methodology used in the guideline adaptation process Only 7% of the guidelines reported conflicts of interest disclosures Guidelines reporting conflict of interests disclosure were more likely to report adaptation methodology (OR = 10.99, 95% CI [2.51, 48.2]).

Findings 58% of the included guidelines were published between 2012 and 2014. 53% of the guidelines originated from the African region. Three out of four guidelines originated from low and LMICs.

Findings 85% of the guidelines explicitly declared name and/or date of publication of the WHO source guideline(s). The two groups most frequently reported to be involved in the adaptation process were governmental representatives (100%) and content experts (79%).

Findings The most frequently reported source of funding were not-for-profit organizations (35%). We observed a lower representation of European and North American countries among the included guidelines.

Findings The 32 guidelines reported any adaptation methodology fulfilled a median of 11.5 steps out of a total of 23 recommended by the ADAPTE process. The numbers of guidelines employing the steps related to the ‘adaptation phase’ of the ADAPTE process were particularly very low.

Findings Number of guidelines (out of 32) fulfilling each of the 23 ADAPTE steps Set-up Phase Finalization Phase Adaptation Phase

Findings The failure in reporting steps relevant to the adaptation phase might be attributed to either; lack of pertinent expertise in adapting guidelines; and/or deficiency in reporting/not following the necessary steps of adaptation process

Implications Future national adaptations of WHO guidelines need to explicitly report their steps in a clear and transparent methodology. They need to use a widely accepted and standardized adaptation methodology.

Implications This will make the process of evaluating the present impact of the guidelines and the changes deemed necessary in the future more formal, documentable and defendable vis-à-vis political decision-makers

Implications We suggest that developers of guidelines that may be later adapted (e.g., WHO), to use a structured, explicit and transparent process to facilitate the process of national guidelines’ adaptation and increase its quality rigor

Implications There is a need to develop and validate a standardized tool studies for assessing guidelines’ adaptation methodological quality.

Acknowledgment Rima A. Abdul Khalek, PharmD Lama Kilzar, BS Hiba Zeid, BS Acile Nahlawi Luciane Cruz Lopes Andrea J. Darzi, MD, MPH Holger J. Schünemann, MD, MSc, PhD Elie A. Akl, MD, MPH, PhD

Thank You