Evidence-Based Guidelines for Mental, Neurological, and Substance Use Disorders in Low- and Middle-Income Countries: Summary of WHO Recommendations

Strengths and Limitations of the Process

Developing recommendations is a complex process that involves systematic review and assessment of the quality of evidence and balance of benefits and harms. In addition, explicit consideration of other issues such as value judgments, resource use, and feasibility, which are major considerations, need to be incorporated. Developing mhGAP recommendations within this framework highlighted several challenging and critical issues, including difficulties in formulating questions and rating outcomes, potential reproducibility and consistency problems, problems in incorporating observational evidence when evidence in the form of randomized trials was not available, and difficulties in defining how values, preferences, and feasibility issues should be considered, as the methodology for these aspects is much less developed [12].

The mhGAP guidelines highlight issues where uncertainty or controversy exists or areas where a change in policy or clinical practice is needed. Table 9 provides examples of some areas where the review of evidence, values, and resource considerations supported the change required in clinical practice.

One of the most challenging aspects of the whole process was that while for some mental health areas the background evidence was quite robust, for others the conventional way of synthesizing and evaluating the evidence revealed no or very poor quality evidence that was insufficient to make any recommendation. For example, some psychosocial interventions for individuals with psychosis or bipolar disorder are backed by few studies that provide inconclusive results. In such instances we took advantage of the GRADE methodology, which clearly recognizes that in addition to the evidence base, other aspects that are expected to inform the recommendations include consideration of values such as protection of human rights, feasibility and resource use, and GDG professional experience and their tacit knowledge. As previously noted, the added value of GRADE in these circumstances is that it requires GDG to transparently report that some recommendations are based on strong values and weak evidence [12]. By contrast, in other areas where a substantial amount of evidence is available, positive recommendations could not be issued due to considerations on feasibility aspects. For example, full cognitive behavioural therapy may be hardly feasible in many low- and middle-income settings considering the training, supervision, and time needed for this intervention, and taking into consideration the need for local adaptations. Similarly, drug treatments that require regular blood checks may not be recommended in settings where no infrastructure is available to provide such checks on a continuous basis.

Another challenging aspect was that while the main focus of WHO's mental health work was to develop recommendations for health care providers in low- and middle-income settings, most of the evidence comes from specialist settings of high-income countries. Despite this, we developed and applied instructions to overcome this compelling issue [12]; increasing implementation research in the contexts where the guidelines should eventually be applied would seem the best approach to enhance the applicability of research findings into practice.

Maintaining and Updating mhGAP Recommendations

Maintaining and updating evidence-based recommendations is similarly relevant, as new evidence is continuously generated and accumulated in the international literature. Updating of mhGAP recommendations will not only be based on this new evidence, but also on feedback from health care professionals, policy-makers, scientists, and public health experts involved in implementing the guidelines. We also expect that revisions might include review of new questions or areas currently not covered by mhGAP guidelines, which might be identified as relevant questions to be addressed. In order to facilitate and encourage feedback, an electronically accessible web repository of recommendations and background material, including all the evidence profiles that were used to generate the recommendations, has recently been developed and will be regularly maintained and updated (http://www.who.int/mental_health/mhgap/evidence/en/index.html). The readers of this article can also provide their feedback by posting comments online at PLoS Medicine. WHO will follow a systematic procedure for updating the recommendations following the same strict and transparent methodological process that was employed for their initial development.

Guideline Implementation Issues

Scaling up delivery of interventions and achieving a desirable level of mental health care quality requires a dynamic and collaborative approach. Research findings that are generated by studies and trials should guide health care providers when making decisions in clinical practice. However, it is very difficult for the individual health care provider to interpret the existing evidence coming from randomized controlled trials, observational studies, and other sources of scientific evidence. Even if the evidence is systematically reviewed, the translation into the relevant policy and programme decisions, as well as the implementation in practice, is not straightforward. Effective strategies, techniques, and incentives are needed to disseminate and implement the guidelines. Finally, the interventions need to be adopted and integrated into practice by providers at all levels [13].

In the field of mental health care, the issue of how guidelines should be implemented to maximize their impact on clinician performance and patient outcome has rarely been investigated. A recent meta-analysis of different guideline implementation strategies included only 18 studies, nine of which were randomized trials [14]. The analysis of these 18 studies revealed that multifaceted interventions were more likely to have an impact on clinician performance and patient outcome, albeit effect sizes were generally modest. Additionally, it has been shown that audit of clinical activities and feedback to doctors may be a relevant component of any implementation strategy [15]. These findings are in line with those of a landmark systematic review of implementation studies [16].

The scarce evidence base on how guidelines should be implemented must not weaken international efforts to develop and evaluate implementation plans [17]. As part of the WHO implementation strategy, mhGAP recommendations have been incorporated into an integrated package of interventions called mhGAP Intervention Guide (mhGAP-IG) for Mental, Neurological and Substance Use Disorders in Non-specialized Health Settings [18]. The mhGAP-IG translates the evidence-based recommendations into simple clinical protocols and algorithms to facilitate decision making for assessment and management. It is aimed at non-specialist health care providers working at first- and second-level facilities. It is important that they are trained and then supervised and supported by the specialists.

The mhGAP-IG provides an integrated package of interventions for the management of priority MNS disorders. The reasons for integrated packages are the following: one, packages are an effective and efficient way of improving health service delivery. Two, delivery of interventions as a package is relatively cost-effective in terms of training and supervision. Many interventions and conditions go naturally together because they can be delivered by the same person at different times and because a limited range of interventions are applicable to a variety of conditions. Three, packages help concentrate scarce resources on the services that provide the best “value for the money”. We believe that the implementation of mhGAP guidelines and scaling them up would lead to a decrease in the burden of MNS disorders. For example, 7 million DALYs (11% of burden due to depression) are avertable with 50% coverage with interventions for depression (anti-depressant drugs [generic TCAs or SSRIs] plus brief psychotherapy) [19]. Similarly, 23% of burden due to epilepsy is avertable at 50% coverage with standard antiepileptic drugs [20]. Thus, the gains that are possible from scaling up of the integrated package could be substantial.

Although the mhGAP-IG is the principal clinical tool being used as part of the scaling up strategy of the mhGAP program in countries, accompanying training materials are being developed for capacity building. Program implementation using the mhGAP-IG has already started in four countries: Ethiopia, Jordan, Nigeria, and Panama [21]. There are a number of major implementation research questions that now need addressing. mhGAP has provided a definitive platform to define “what” should be scaled up. The “how” question needs answering now. An example of such an initiative is the multi-partner PRogramme for Improving Mental health carE (PRIME) Project, which has the objective to generate evidence on the implementation and scaling up of treatment programmes for priority mental disorders in low-resource settings [22]. In the near future, further efforts should be made to introduce formal evaluations of the capability of these programs to induce relevant and persistent changes, and to generate useful insights on how implementation in LAMIC should be conducted to maximize benefit at sustainable costs.