Outcomes research resources in India: current status, need and way forward

Outcomes research is concerned with determining the end results and in turn the effectiveness of healthcare practices, interventions and systems. Outcomes research focuses on topics ranging from effectiveness, appropriateness, access, quality of care, quality of life, health status, disease prevention, screening, drug treatment, medical procedures, medical practices, diagnostic tests, guidelines and healthcare policy (Jefford et al. 2003).

Despite the role of outcomes research studies in discerning practice variation (Pilote and Tager 2002), quality of care and determining “What actually works”, a quick literature search in Gopubmed (GoPubMed® 2013) conducted by the authors revealed that the number of outcomes research studies in India have been lower in comparison to countries like USA, UK and Germany. (9362, 195663, 46028, 36693 respectively). (Search strategy: “Outcome Assessment (Health Care)”[mesh], Gopubmed,) Although there is a lack of studies evaluating the reason behind this trend, paucity of funding, non availability of infrastructure, lack of relevant expertise and trained staff could be factors responsible for this trend. Even when these factors are available, there exists a significant disconnect amongst them as data about existing resources is not widely accessible. If made available, information about existing resources can help 1. Policy makers to plan efficient strategies that can build up on existing outcomes research resources thus ensuring economies of scale as well as predict resource use and improve efficiency in the allocation of resources (Liu et al. 2008). 2. Researchers and research groups become aware of existing research resources thus avoiding duplication and facilitating higher productivity at a lower cost. Despite the importance of this information, till date no previous study has worked on compiling and sharing this information in a systematic manner.

India currently faces a mixed burden of both communicable and non-communicable diseases, the latter responsible for two-third of the total morbidity burden and more than half (53%) of total mortality in India. (WHO 2013) This dual burden poses significant public health challenges before India like safeguarding public health, expanding health care coverage and improving quality of care while controlling costs. Given the current economic downturn, Indian policy makers need to take cue from Australia, Japan, South Korea and China where Outcomes Research data are used for setting national policy, designing drug formulary and drafting pharmaceutical economics guidelines. (Garman 2013) In order to encourage and facilitate the conduct of outcomes research studies, knowledge, access and sustained support of pre-existing resources is essential. Few studies have mapped outcomes research resources in India.

In order to bridge this gap, we carried out a review of the literature to identify and map resources described in previous outcomes research studies conducted in India.

To the best of our knowledge, this is the first study that carried out a systematic analysis of outcomes research resources in India as reported in published literature. We collected information relevant to 91 outcomes research resources in India and report details about each resource, bibliometric data of publications derived from these resources and researchers that conducted research studies using data derived from these resources.

We observed a predominance of registries and databases in India. Research registries collect long term clinical, health services and epidemiological data for a given population. They are essential to understand clinical and epidemiological trends as well as useful for policy analyses, planning and management of health care resources. (Roos and Nicole, Roos and Nicol 1999) (Broemeling et al. 2009). Databases are usually study specific or project specific. They are usually designed to collect data to answer a specific research question. The low number of EMR, EHR and HIS in India might be because of the fact that India has been slow in the adoption of biomedical and research informatics tools. Although having a wide range of advantages (Fraser et al., 2005) (Lobach and Detmer, 2007) (Mildon and Cohen, 2001) (Rustagi and Singh, 2012) concerns about privacy, reduction in clinical productivity, being resource intensive, (Rustagi and Singh, 2012) (Kluger, 2009) high purchase and maintenance costs make their adoption slower (Jha et al., 2009) (Hillestad et al., 2005).

We observed a geographical predominance of resources and researchers in southern and western zones indicating an imbalance. This imbalance may be further complicated by the fact that researchers from one zone may not have access to data from a resource located in another zone. This may significantly influence policy and funding decisions further resulting in a vicious cycle of resource duplication, under utilization of resources, and wastage of funding.

We also observed a predominance of Institutional and regional initiatives in spearheading/managing the resources. Although this trend is noteworthy and beneficial, it reflects small scale and medium scale research projects. National registries have their own importance in nationwide policy decisions as data cannot always be extrapolated from regional data. There are numerous examples of large scale nationwide initiatives like Nationwide inpatient sample (HCUP-US NIS, 2013), National Health Insurance Research Database (NHRI, Taiwan, 2013), Disease registries maintained by National Registry of Diseases Office (NRDO, Singapore, 2013) that have and continue to significantly contribute to national healthcare decision making and planning as well as in the improvement of quality of healthcare. Thus a balanced distribution of regional and national resources is essential. We also noted that most of the resources and researchers were located in Government or Privately owned academic organizations. Although a good trend, these organizations usually serve the urban population and provide tertiary care. Given the fact that India is largely an agrarian country, equitable distribution of resources into urban and rural areas would facilitate the collection of data that is truly representative of the Indian population. Policies derived from such a representative sample will be more effective than those based on extrapolated data that do not represent real life scenarios.

Most of the resources collected data on Cancer, Stroke and Diabetes. Given the significant rise in cancer, cardiovascular and metabolic disorders in India, (Takiar et al., 2010) (Young et al., 2009) this distribution appears to be moving in the right direction. Yet, it should be noted that there exists a vast difference amongst number of resources in each of these groups indicating a predominance of cancer resources. Accordingly, it prepares the case for the need of similar outcomes data resources for nationally prevalent diseases like Malaria, Tuberculosis. This can be implemented by incorporating relevant outcomes data variables in surveillance and national programs.

A predominance of publications derived from the short listed resources in international journals is a good trend as it helps disseminate results to a global audience. Yet the Journal impact factor (JIF) and citation index of these publications may be indicative of the quality and impact of results published. Training programs to help clinicians and researchers collect data using global accepted data standards and report them using standard reporting guidelines may make future publications reach a larger audience and gain higher impact. In this regard, a workshop on imparting outcomes research skills to medical faculty members was recently conducted with the aid of Indian Council of Medical Research. (Savardekar L, Shah J, Bacchav S, Kshirsagar N, Translating Ideas into Research Projects and Manuscripts in Outcomes Research:Experiences of An ICMR Workshop. unpublished observations).

Most of the registries and databases identified through this study have not been explored to their true potential. In most cases, data from these registries have resulted in one to three publications. Further, most of them do not have their own websites or web pages within their organization. Sharing of data dictionaries or actual data – a norm of current times is hardly applicable to these resources. This demonstrates that detailed information about these resources is not easily accessible. The Department of Science and Technology (India) conducted a National Survey on Resources Devoted to Science &Technology Activities (National Science & Technology Management Information System, India, 2013) but the resultant data is not publicly available. Secondly, the survey questionnaire does not capture granular information about research resources. Finally, we are not aware about its utility and effectiveness in facilitating collaborations and guiding policy decisions at a state and national level. It is thus evident that awareness of existing outcomes research resources in India is low thus impairing the ability of 1. Researchers and research groups to optimally utilize existing outcomes data for carrying out outcomes research studies and 2. Research policy makers to utilize resource availability and resource performance data while making resource allocation decisions.

Given the importance of Outcomes research, relevant resources should be supported and encouraged which would help in the generation of important healthcare data that can guide health and research policy. Clarity about the distribution of outcomes research resources can facilitate future resource and funding allocation decisions for policy makers as well as help them measure research performance over time.