Ensuring quality in contextualised cancer management guidelines for resource-constraint settings: using a systematic approach.

To address the wide variation in access to cancer care in India requires strengthening of infrastructure, trained oncology workforce, and minimisation of out-of-pocket expenditures. However, even with major investments, it is unlikely to achieve the same level of infrastructure and expertise across the country. Therefore, a resource stratified approach driven by evidence-based and contextualised clinical guidelines is the need of the hour. The National Cancer Grid has been at the forefront of delivery of standardised cancer care through several of its initiatives, including the resource-stratified guidelines. Development of new guidelines is resource and time intensive, which may not be feasible and can delay the implementation. Adaptation of the existing standard guidelines using the transparent and well-documented methodology with involvement of all stakeholders can be one of the most reasonable pathways. However, the adaptation should be done keeping in mind the context, resource availability, budget impact, investment needed for implementation and acceptability by clinicians, patients, policymakers, and other stakeholders. The present paper provides the framework for systematically developing guidelines through adaptation and contextualisation. The process can be used for other health conditions in resource-constraint settings.

A Reporting Tool for Adapted Guidelines in Health Care: The RIGHT-Ad@pt Checklist.

BACKGROUND: Adaptation of existing guidelines can be an efficient way to develop contextualized recommendations. Transparent reporting of the adaptation approach can support the transparency and usability of the adapted guidelines. OBJECTIVE: To develop an extension of the RIGHT (Reporting Items for practice Guidelines in HealThcare) statement for the reporting of adapted guidelines (including recommendations that have been adopted, adapted, or developed de novo), the RIGHT-Ad@pt checklist. DESIGN: A multistep process was followed to develop the checklist: establishing a working group, generating an initial checklist, optimizing the checklist (through an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review, and a final assessment of adapted guidelines), and approval of the final checklist by the working group. SETTING: International collaboration. PARTICIPANTS: A total of 119 professionals participated in the development process. MEASUREMENTS: Participants' consensus on items in the checklist. RESULTS: The RIGHT-Ad@pt checklist contains 34 items grouped in 7 sections: basic information (7 items); scope (6 items); rigor of development (10 items); recommendations (4 items); external review and quality assurance (2 items); funding, declaration, and management of interest (2 items); and other information (3 items). A user guide with explanations and real-world examples for each item was developed to provide a better user experience. LIMITATION: The RIGHT-Ad@pt checklist requires further validation in real-life use. CONCLUSION: The RIGHT-Ad@pt checklist has been developed to improve the reporting of adapted guidelines, focusing on the standardization, rigor, and transparency of the process and the clarity and explicitness of adapted recommendations. PRIMARY FUNDING SOURCE: None.

Current practices and challenges in adaptation of clinical guidelines: a qualitative study based on semistructured interviews.

OBJECTIVE: This study aims to better understand the current practice of clinical guideline adaptation and identify challenges raised in this process, given that published adapted clinical guidelines are generally of low quality, poorly reported and not based on published frameworks. DESIGN: A qualitative study based on semistructured interviews. We conducted a framework analysis for the adaptation process, and thematic analysis for participants' views and experiences about adaptation process. SETTING: Nine guideline development organisations from seven countries. PARTICIPANTS: Guideline developers who have adapted clinical guidelines within the last 3 years. We identified potential participants through published adapted clinical guidelines, recommendations from experts, and a review of the Guideline International Network Conference attendees' list. RESULTS: We conducted ten interviews and identified nine adaptation methodologies. The reasons for adapting clinical guidelines include developing de novo clinical guidelines, implementing source clinical guidelines, and harmonising and updating existing clinical guidelines. We identified the following core steps of the adaptation process (1) selection of scope and source guideline(s), (2) assessment of source materials (guidelines, recommendations and evidence level), (3) decision-making process and (4) external review and follow-up process. Challenges on the adaptation of clinical guidelines include limitations from source clinical guidelines (poor quality or reporting), limitations from adaptation settings (lacking resources or skills), adaptation process intensity and complexity, and implementation barriers. We also described how participants address the complexities and implementation issues of the adaptation process. CONCLUSIONS: Adaptation processes have been increasingly used to develop clinical guidelines, with the emergence of different purposes. The identification of core steps and assessment levels could help guideline adaptation developers streamline their processes. More methodological research is needed to develop rigorous international standards for adapting clinical guidelines.

Improving antibiotic prescribing for community-acquired pneumonia in a provincial hospital in Northern Vietnam.

OBJECTIVES: To test the effectiveness of a quality improvement programme to promote adherence to national quality standards (QS) for patients hospitalized with community-acquired pneumonia (CAP), exploring the factors that hindered improvements in clinical practice. METHODS: An improvement bundle aligned to the QS was deployed using plan-do-study-act methodology in a 600 bed hospital in northern Vietnam from July 2018 to April 2019. Proposed care improvements included CURB65 score guided hospitalization, timely diagnosis and inpatient antibiotic treatment review to limit the spectrum and duration of IV antibiotic use. Interviews with medical staff were conducted to better understand the barriers for QS implementation. RESULTS: The study found that improvements were made in CURB65 score documentation and radiology results available within 4 h (P < 0.05). There were no significant changes in the other elements of the QS studied. We documented institutional barriers relating to the health reimbursement mechanism and staff cultural barriers relating to acceptance and belief as significant impediments to implementation of the standards. CONCLUSIONS: Interventions led to some process changes, but these were not utilized by clinicians to improve patient management. Institutional and behavioural barriers documented may inhibit wider national uptake of the QS. National system changes with longer term support and investment to address local behavioural barriers are likely to be crucial for future improvements in the management of CAP, and potentially other hospitalized conditions, in Vietnam.

Assessment of the quality of recommendations from 161 clinical practice guidelines using the Appraisal of Guidelines for Research and Evaluation-Recommendations Excellence (AGREE-REX) instrument shows there is room for improvement.

OBJECTIVE: To assess the quality of recommendations from 161 clinical practice guidelines (CPGs) using AGREE-REX-D (Appraisal of Guidelines REsearch and Evaluation-Recommendations Excellence Draft). DESIGN: Cross-sectional study SETTING: International CPG community. PARTICIPANTS: Three hundred twenty-two international CPG developers, users, and researchers. INTERVENTION: Participants were assigned to appraise one of 161 CPGs selected for the study using the AGREE-REX-D tool MAIN OUTCOME MEASURES: AGREE-REX-D scores of 161 CPGs (7-point scale, maximum 7). RESULTS: Recommendations from 161 CPGs were appraised by 322 participants using the AGREE-REX-D. CPGs were developed by 67 different organizations. The total overall average score of the CPG recommendations was 4.23 (standard deviation (SD) = 1.14). AGREE-REX-D items that scored the highest were (mean; SD): evidence (5.51; 1.14), clinical relevance (5.95; SD 0.8), and patients/population relevance (4.87; SD 1.33), while the lowest scores were observed for the policy values (3.44; SD 1.53), local applicability (3,56; SD 1.47), and resources, tools, and capacity (3.49; SD 1.44) items. CPGs developed by government-supported organizations and developed in the UK and Canada had significantly higher recommendation quality scores with the AGREE-REX-D tool (p < 0.05) than their comparators. CONCLUSIONS: We found that there is significant room for improvement of some CPGs such as the considerations of patient/population values, policy values, local applicability and resources, tools, and capacity. These findings may be considered a baseline upon which to measure future improvements in the quality of CPGs.

Increasing identification of foot at risk of complications in patients with diabetes: a quality improvement project in an urban primary health centre in India.

The majority of foot amputations are preventable in people with diabetes. Guidelines recommend that people with diabetes should receive a foot examination for risk assessment, at least annually. In an audit at a primary health centre (PHC) in Mumbai, India, no patient with diabetes was offered preventive foot assessment in preceding 12 months. Problem analysis identified a lack of clinic policy, training and equipment for foot assessment. There was no standardised referral pathway for patients identified with foot at risk of diabetes complications. Furthermore, limited data review, high patient volumes and little time available with healthcare providers were important constraints. A quality improvement project was carried out at the PHC from January to September 2017. The project aimed at increasing compliance to standardised foot assessment in patients with diabetes presenting to the PHC from a baseline of 0% to 100% over 6 months. This would help identify patients having a foot at risk of complications due to diabetes. The Quality Standard on foot assessment was adopted from the Ministry of Health and Family Welfare Diabetic Foot Guideline. The electronic medical record (EMR) was standardised, health providers were trained, PHC processes and referral pathways were redesigned. Plan-Do-Study-Act was used to address barriers with weekly data review. 88.2% (848) of patients with diabetes visiting the PHC during the study period received a foot examination. Out of these, 11% (95) were identified to have a foot at risk and referred to a specialist foot centre. 57% of referred patients followed with specialised foot protection services. Training of healthcare providers, standardisation of processes and regular data feedback can improve diabetic foot care. Integrating quality indicators in the EMR helps monitor compliance. The inability to use doctor's time efficiently was the biggest challenge and sustaining the change will require organisational changes with suitable task shifting.

Development and Validation of a Tool to Assess the Quality of Clinical Practice Guideline Recommendations.

Importance: Clinical practice guidelines (CPGs) may lack rigor and suitability to the setting in which they are to be applied. Methods to yield clinical practice guideline recommendations that are credible and implementable remain to be determined. Objective: To describe the development of AGREE-REX (Appraisal of Guidelines Research and Evaluation-Recommendations Excellence), a tool designed to evaluate the quality of clinical practice guideline recommendations. Design, Setting, and Participants: A cross-sectional study of 322 international stakeholders representing CPG developers, users, and researchers was conducted between December 2015 and March 2019. Advertisements to participate were distributed through professional organizations as well as through the AGREE Enterprise social media accounts and their registered users. Exposures: Between 2015 and 2017, participants appraised 1 of 161 CPGs using the Draft AGREE-REX tool and completed the AGREE-REX Usability Survey. Main Outcomes and Measures: Usability and measurement properties of the tool were assessed with 7-point scales (1 indicating strong disagreement and 7 indicating strong agreement). Internal consistency of items was assessed with the Cronbach α, and the Spearman-Brown reliability adjustment was used to calculate reliability for 2 to 5 raters. Results: A total of 322 participants (202 female participants [62.7%]; 83 aged 40-49 years [25.8%]) rated the survey items (on a 7-point scale). All 11 items were rated as easy to understand (with a mean [SD] ranging from 5.2 [1.38] for the alignment of values item to 6.3 [0.87] for the evidence item) and easy to apply (with a mean [SD] ranging from 4.8 [1.49] for the alignment of values item to 6.1 [1.07] for the evidence item). Participants provided favorable feedback on the tool's instructions, which were considered clear (mean [SD], 5.8 [1.06]), helpful (mean [SD], 5.9 [1.00]), and complete (mean [SD], 5.8 [1.11]). Participants considered the tool easy to use (mean [SD], 5.4 [1.32]) and thought that it added value to the guideline enterprise (mean [SD], 5.9 [1.13]). Internal consistency of the items was high (Cronbach α = 0.94). Positive correlations were found between the overall AGREE-REX score and the implementability score (r = 0.81) and the clinical credibility score (r = 0.76). Conclusions and Relevance: This cross-sectional study found that the AGREE-REX tool can be useful in evaluating CPG recommendations, differentiating among them, and identifying those that are clinically credible and implementable for practicing health professionals and decision makers who use recommendations to inform clinical policy.

Extending the RIGHT statement for reporting adapted practice guidelines in healthcare: the RIGHT-Ad@pt Checklist protocol.

INTRODUCTION: The adaptation of guidelines is an increasingly used methodology for the efficient development of contextualised recommendations. Nevertheless, there is no specific reporting guidance. The essential Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement could be useful for reporting adapted guidelines, but it does not address all the important aspects of the adaptation process. The objective of our project is to develop an extension of the RIGHT statement for the reporting of adapted guidelines (RIGHT-Ad@pt Checklist). METHODS AND ANALYSIS: To develop the RIGHT-Ad@pt Checklist, we will use a multistep process that includes: (1) establishment of a Working Group; (2) generation of an initial checklist based on the RIGHT statement; (3) optimisation of the checklist (an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review by guideline developers and users and a final assessment of adapted guidelines); and (4) approval of the final checklist. At each step of the process, we will calculate absolute frequencies and proportions, use content analysis to summarise and draw conclusions, discuss the results, draft a report and refine the checklist. ETHICS AND DISSEMINATION: We have obtained a waiver of approval from the Clinical Research Ethics Committee at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain). We will disseminate the RIGHT-Ad@pt Checklist by publishing into a peer-reviewed journal, presenting to relevant stakeholders and translating into different languages. We will continuously seek feedback from stakeholders, surveil new relevant evidence and, if necessary, update the checklist.

Budgeting for a billion: applying health technology assessment (HTA) for universal health coverage in India.

BACKGROUND: India recently launched the largest universal health coverage scheme in the world to address the gaps in providing healthcare to its population. Health technology assessment (HTA) has been recognised as a tool for setting priorities as the government seeks to increase public health expenditure. This study aims to understand the current situation for healthcare decision-making in India and deliberate on the opportunities for introducing HTA in the country. METHODS: A paper-based questionnaire, adapted from a survey developed by the International Decision Support Initiative (iDSI), was administered on the second day of the Topic Selection Workshop that was conducted as part of the HTA Awareness Raising Workshop held in New Delhi on 25-27 July, 2016. Participants were invited to respond to questions covering the need, demand and supply for HTA in their context as well as the role of their organisation vis-à-vis HTA. The response rate for the survey was about 68% with 41 participants having completed the survey. RESULTS: Three quarters of the respondents (71%) stated that the government allocated healthcare resources on the basis of expert opinion. Most respondents indicated reimbursement of individual health technologies and designing a basic health benefit package (93% each) were important health policy areas while medical devices and screening programmes were cited as important technologies (98% and 92%, respectively). More than half of the respondents noted that relevant local data was either not available or was limited. Finally, technical capacity was seen as a strength and a constraint facing organisations. CONCLUSION: The findings from this study shed light on the current situation, the opportunities, including potential topics, and challenges in conducting HTA in India. There are limitations to the study and further studies may need to be conducted to inform the role that HTA will play in the design or implementation of universal health coverage in India.

Validity and usability testing of a health systems guidance appraisal tool, the AGREE-HS.

BACKGROUND: Health systems guidance (HSG) provides recommendations to address health systems challenges. No tools exist to inform HSG developers and users about the components of high quality HSG and to differentiate between HSG of varying quality. In response, we developed a tool to assist with the development, reporting and appraisal of HSG - the Appraisal of Guidelines for Research and Evaluation-Health Systems (AGREE-HS). This paper reports on the validity, usability and initial measurement properties of the AGREE-HS. METHODS: To establish face validity (Study 1), stakeholders completed a survey about the AGREE-HS and provided feedback on its content and structure. Revisions to the tool were made in response. To establish usability (Study 2), the revised tool was applied to 85 HSG documents and the appraisers provided feedback about their experiences via an online survey. An initial test of the revised tool's measurement properties, including internal consistency, inter-rater reliability and criterion validity, was conducted. Additional revisions to the tool were made in response. RESULTS: In Study 1, the AGREE-HS Overview, User Manual, quality item content and structure, and overall assessment questions were rated favourably. Participants indicated that the AGREE-HS would be useful, feasible to use, and that they would apply it in their context. In Study 2, participants indicated that the quality items were easy to understand and apply, and the User Manual, usefulness and usability of the tool were rated favourably. Study 2 participants also indicated intentions to use the AGREE-HS. CONCLUSIONS: The AGREE-HS comprises a User Manual, five quality items and two overall assessment questions. It is available at agreetrust.org.

Identification of publicly available data sources to inform the conduct of Health Technology Assessment in India.

Background: Health technology assessment (HTA) provides a globally-accepted and structured approach to synthesising evidence for cost and clinical effectiveness alongside ethical and equity considerations to inform evidence-based priorities. India is one of the most recent countries to formally commit to institutionalising HTA as an integral component of the heath resource allocation decision-making process. The effective conduct of HTA depends on the availability of reliable data.   Methods: We draw from our experience of collecting, synthesizing, and analysing health-related datasets in India and internationally, to highlight the complex requirements for undertaking HTA, and explore the availability of such data in India. We first outlined each of the core data components required for the conduct of HTA, and their availability in India, drawing attention to where data can be accessed, and different ways in which researchers can overcome the challenges of missing or low quality data. Results: We grouped data into the following categories: clinical efficacy; cost; epidemiology; quality of life; service use/consumption; and equity. We identified numerous large local data sources containing epidemiological information. There was a marked absence of other locally-collected data necessary for informing HTA, particularly data relating to cost, service use, and quality of life. Conclusions: The introduction of HTA into the health policy space in India provides an opportunity to comprehensively assess the availability and quality of health data capture across the country. While epidemiological information is routinely collected across India, other data inputs necessary for HTA are not readily available. This poses a significant bottleneck to the efficient generation and deployment of HTA into the health decision space. Overcoming these data gaps by strengthening the routine collection of comprehensive and verifiable health data will have important implications not only for embedding economic analyses into the priority setting process, but for strengthening the health system as a whole.

Institutionalising health technology assessment: establishing the Medical Technology Assessment Board in India.

India is at crossroads with a commitment by the government to universal health coverage (UHC), driving efficiency and tackling waste across the public healthcare sector. Health technology assessment (HTA) is an important policy reform that can assist policy-makers to tackle inequities and inefficiencies by improving the way in which health resources are allocated towards cost-effective, appropriate and feasible interventions. The equitable and efficient distribution of health budget resources, as well as timely uptake of good value technologies, are critical to strengthen the Indian healthcare system. The government of India is set to establish a Medical Technology Assessment Board to evaluate existing and new health technologies in India, assist choices between comparable technologies for adoption by the healthcare system and improve the way in which priorities for health are set. This initiative aims to introduce a more transparent, inclusive, fair and evidence-based process by which decisions regarding the allocation of health resources are made in India towards the ultimate goal of UHC. In this analysis article, we report on plans and progress of the government of India for the institutionalisation of HTA in the country. Where India is home to one-sixth of the global population, improving the health services that the population receives will have a resounding impact not only for India but also for global health.

Improving quality for maternal care - a case study from Kerala, India.

BACKGROUND: The implementation of maternal health guidelines remains unsatisfactory, even for simple, well established interventions. In settings where most births occur in health facilities, as is the case in Kerala, India, preventing maternal mortality is linked to quality of care improvements. CONTEXT: Evidence-informed quality standards (QS), including quality statements and measurable structure and process indicators, are one innovative way of tackling the guideline implementation gap. Having adopted a zero tolerance policy to maternal deaths, the Government of Kerala worked in partnership with the Kerala Federation of Obstetricians & Gynaecologists (KFOG) and NICE International to select the clinical topic, develop and initiate implementation of the first clinical QS for reducing maternal mortality in the state. Description of practice: The NICE QS development framework was adapted to the Kerala context, with local ownership being a key principle. Locally generated evidence identified post-partum haemorrhage as the leading cause of maternal death, and as the key priority for the QS. A multidisciplinary group (including policy-makers, gynaecologists and obstetricians, nurses and administrators) was established. Multi-stakeholder workshops convened by the group ensured that the statements, derived from global and local guidelines, and their corresponding indicators were relevant and acceptable to clinicians and policy-makers in Kerala. Furthermore, it helped identify practical methods for implementing the standards and monitoring outcomes. LESSONS LEARNED: An independent evaluation of the project highlighted the equal importance of a strong evidence-base and an inclusive development process. There is no one-size-fits-all process for QS development; a principle-based approach might be a better guide for countries to adapt global evidence to their local context.

Quality of Health Care in Ghana: Mapping of Interventions and the Way Forward.

BACKGROUND: Ghana has made major strides in improving access to health services. Despite these improvements, Ghana did not meet the Millennium Development Goals 4 and 5. Quality of care is a major factor that could explain this shortfall. OBJECTIVE: To understand current practice and to identify needs in the area of quality of care in Ghana for improving health outcomes and to guide the National Institute for Health and Care Excellence (NICE) in supporting the care quality improvement efforts in Ghana. METHODS: The directory of existing standards, guidelines and protocols of the Ghana Health Service was reviewed and sixteen in-depth interviews were conducted to identify interventions that addressed quality of care. Additional information was obtained during a NICE scoping visit to Accra followed by a study tour of Ghanaian stakeholders to NICE and to the National Health Service. RESULTS: Since 1988, 489 policy interventions have been identified that address quality of care. Among them, the development of health protocols and guidelines were the most frequent interventions (n=150), followed by health policies and strategies (n=106); interventions related to health information (n=77); development of training manuals and staff training (n=69); development of regulations (n=38) and interventions related to organisation of services (n=15). CONCLUSIONS: Ghana has made significant efforts in developing guidelines, policies and conducting in-service training. Supervision, monitoring and evaluation have also received attention. However, less effort has been made in developing processes and systems and involving communities and service users. Some recommendations were made to guide the future work on quality of care. FUNDING: Rockefeller Foundation.