van der Graaf, Y.

van der Heijden, G.J.M.G.

Wangge, G.

Widyahening, I.S.

English

Rationale, aims and objectives: Most of the clinical guidelines in low-resource countries are adaptations from preexisting international guidelines. This adaptation can be problematic when those international guidelines are not based on current evidence or original evidence-based international guidelines are not followed. This study aims to evaluate the quality of an Indonesian type 2 diabetes mellitus guideline adapted from selected international guidelines. Methods: The “Consensus on the Management and Prevention of type 2 Diabetes in Indonesia 2011” is a guideline by the Indonesian Society of Endocrinology (Perkeni). Four parent guidelines identified from its list of references were from the International Diabetes Federation (IDF), American Association of Clinical Endocrinologist (AACE), American Diabetes Association (ADA), and one jointly released by ADA and European Association for the Study of Diabetes (EASD). Two reviewers independently assessed its quality using the Appraisal of Guidelines, Research and Evaluation Collaboration (AGREE II) instrument. Six recommendations were compared: (1) screening for diabetes; (2) diagnosis; (3) control of hyperglycemia; (4) target blood glucose; (5) target blood pressure; and (6) treatment of dyslipidemia. Results: Perkeni's guideline satisfied 55% of the AGREE II items, while its parent guidelines satisfied 59% to 74%. Perkeni's shows low score on “rigor of development” and “applicability” and the lowest score in the “scope and purpose” domain. Differences were found in 4 recommendations: the screening of diabetes, control of hyperglycemia, target blood glucose, and treatment of dyslipidemia. In 3 of 4, Perkeni followed the ADA's recommendation. Conclusion: Derivation of recommendations from parent guidelines and their adaptation to the context of Indonesian health care lacks transparency. When guidelines are either derived from other guidelines or adapted for use in different context, evidence-based practice principles should be followed and adhered to.</p

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Table 3. Comparison of the recommendation in the Perkeni guidelines and the parent guidelines and the level of the evidence supporting the recommendation.  	Recommendations from the Parent guidelines; (levels of evidence*)	Perkeni recommendation	Parent guidelines from which recommendation  is derivedTopics	AACE	ADA	IDF	ADA-EASD	 	 Prevention	Annually screen all individuals 30 years or older with any of the listed risk factors (overweight/ obese among others)	Testing should be considered in all adults who are overweight (BMI  25 kg/m2) and have additional risk factors	Detection programs should target high-risk people identified by assessment of risk factors*	N.A	Testing should be considered in all adults with any of the listed risk factors (age>45 and BMI >23 among others).	AACE and ADA			*the risk factors is not clearly stated; 			Strength of the recommendation (as stated in each respective guidelines)	Grade B	grade B 	not provided	 	 	 References	AACE Consensus Conference (2006); Experts’ consensus based on literature review	Engelgau et al (2000); technical review with cost-benefit analysis	WHO report (2003), UKPDS 6 (1990), Harris (1992, cohort study) 	 	 	 Levels of evidence (Oxford CEBM 2009)	 	 	 	 	 	  	Recommendations from the Parent guidelines; (levels of evidence*)	Perkeni recommendation	Parent guidelines from which recommendation  is derivedTopics	AACE	ADA	IDF	ADA-EASD	 	 Diagnosis	FBG > 126 or Random BG > 200 for those with classic DM symptoms.	FBG > 126 or Random BG > 200 for those with classic DM symptoms.	FBG > 126 or Random BG > 200 for those with classic DM symptoms.	N.A	FBG > 126 or Random BG > 200 for those with classic DM symptoms.	All similar	Positive BG only without symptoms, should be repeated	Positive BG only without symptoms, should be repeated	Positive BG only without symptoms, should be repeated		Positive BG only without symptoms, should be repeated 	Strength of the recommendation (as stated in each respective guidelines)	Grade B	not provided	not provided	 	 	 Evidence	WHO/IDF (2006); Experts’ consensus based on literature review	ADA Expert committee report (1997)	WHO report (1999), ADA expert committee report (2003)	 	 	 Levels of evidence (Oxford CEBM 2009)	 	 	 	 	 	  	Recommendations from the Parent guidelines; (levels of evidence*)	Perkeni recommendation	Parent guidelines from which recommendation  is derivedControl of hyperglycemia	After diagnosis, life-style modification is advised simultaneously with pharmacologic treatment	After diagnosis, life-style modification is advised simultaneously with pharmacologic treatment (i.e. metformin)	Begin oral glucose-lowering drugs when lifestyle interventions alone are unable to maintain blood glucose control at target levels	After diagnosis, life-style modification is advised simultaneously with pharmacologic treatment	After diagnosis, start with life-style modification 2-4 weeks.  Pharmacology may be given if target blood glucose is not achieved.	IDFStrength of the recommendation (as stated in each respective guidelines)	grade A	not provided	not provided	consensus	 	 Evidence	Esposito K, et al (2004), DCCT (1993), Esposito K, et al (2002), Ohkubo Y (1995), DCCT (2002)	Nathan DM, et al (2006 and 2009); ADA-EASD consensus statement	CMA guidelines (2003), NICE guidelines (2001), Germany guidelines (2004), ICSI guidelines (2004)	RCTs: UKPDS (1998), DCCT (1993), Diabetes Prevention Program Research Group (2005, lifestyle is more effective than metformin), 	 	 	DCCT trial is conducted among type 1 DM using insulin as intervention		UKPDS 34 (1998)			 	 	 	 	Clinical judgement that for most individuals with type 2 diabetes, lifestyle interventions fail to achieve or maintain the metabolic goals.	 	 Levels of evidence (Oxford CEBM 2009)	1b	 	1a	1b	 	  	Recommendations from the Parent guidelines; (levels of evidence*)	Perkeni recommendation	Parent guidelines from which recommendation  is derivedBlood glucose target	HbA1c<6.5;	HbA1c <7 and further below for selected individual	HbA1c<6.5	HbA1c <7 	HbA1c <7	ADA and ADA-EASDStrength of the recommendation (as stated in each respective guidelines)	grade B	grade A (microvascular complication prevention); B (macrovascular)	not provided	not provided	 	 Evidence 	ACE/AACE consensus conference (2006).	Several trials such as the DCCT (1993), EDIC (follow up of DCCT, 2000), UKPDS (1998, and its follow up study 2008), Kumamoto (1995),  ADVANCE (2008) and VADT (2009)	UKPDS 35 (2000), Laakso (1996), Selvin (2004), ADA guidelines (2004 and 2005), European diabetes policy group guidelines (1999), NICE guidelines (2001), CMA guidelines (2003) 	ADA guidelines (2008)	 	  	 	ACCORD trial which shows the harm of further lowering of A1c (2008)	 	 	 	 Levels of evidence (Oxford CEBM 2009)	 	1a	1a	 	 	  	Recommendations from the Parent guidelines; (levels of evidence*)	Perkeni recommendation	Parent guidelines from which recommendation  is derivedBlood pressure target	<130/80 mmHg	<130/80 mmHg	<130/80 mmHg	N.A	130/80 mmHg	All similarStrength of the recommendation (as stated in each respective guidelines)	grade A	grade C for systolic level and B for diastolic level	not provided	 	 	 Evidence	JNC7 Guidelines (2003), 	JNC7 Guidelines (2003), 	Diabetes Australia guidelines (2004), Canadian Diabetes Association guidelines (2003), ADA guidelines (2005), JNC guidelines (2003), European Hypertension Society guidelines (2003)	 	 	 	National Kidney Foundation consensus (2000).	Hanson et al (1998); Hypertension Optimal Treatment Trial	Hanson et al (1998); Hypertension Optimal Treatment Trial	 	 	 	 	UKPDS 38 trial  (1998)	UKPDS 38 trial  (1998)			Levels of evidence (Oxford CEBM 2009)	 	1b	1a	 	 	  	Recommendations from the Parent guidelines; (levels of evidence*)	Perkeni recommendation	Parent guidelines from which recommendation  is derivedStatin prescription	Statins are the pharmacologic treatment of choice	Statin therapy should be added to lifestyle therapy, regardless of  lipid levels for diabetic patients	a) statin for all >40 year old (or all with declared CVD)	N.A	For patient who are >40 years old or have CVD risk, statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels.	ADA and IDF	No further detail whether it should be given according to or regardless of baseline lipid level 	● with overt CVD.	b) statin for all >20 yr old with micro-albuminuria or assessed as being at particularly high risk				 	● without CVD who are over the age of 40 years and have one or more other CVD risk factors.	 			Strength of the recommendation (as stated in each respective guidelines)	grade A for statin recommendation	grade A 	not provided	 	 	 Evidence	Grundy SM et al (National Heart Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association Guidelines 2004).	9 trials of statin: 4S (1997), HPS (2003), TNT (2006), ASCOT-LLA (2005), ASPEN (2006), CARDS (2004) and sub-analysis to those with high CVD risks (HPS and CARDS)	HPS trials (2003), CARDS trial (2004). 	Diabetes Australia guidelines (2004), Canadian Diabetes Association guidelines (2003), NICE guidelines (2002), SIGN guidelines (2001)	 	 	  	Goldberg RB et al (CARE Trial, 1998)	 		 	 	  	10 trials (including HPS and CARDS) and 1 SR about statin	 	 	 	 	 Levels of evidence (Oxford CEBM 2009)	1a	1b	1a	 	 	 * levels of evidence listed in the guidelines was re-classified based on the Oxford 2011 Levels of Evidence for comparison within the matrixN.A. = not applicableUnclear = no rating of evidence is provided and no reference is linked to the recommendation.

Adapting clinical guidelines in low-resources countries:a study on the guideline on the management and prevention of type 2 diabetes mellitus in Indonesia

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Adapting clinical guidelines in low-resources countries:a study on the guideline on the management and prevention of type 2 diabetes mellitus in Indonesia

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