Managing Comorbidities, Determinants and Disability at Start and End of TB Treatment under Routine Program Conditions in China.

Many patients with tuberculosis (TB) have comorbidities, risk determinants and disability that co-exist at diagnosis, during and after TB treatment. We conducted an observational cohort study in 11 health facilities in China to assess under routine program conditions (i) the burden of these problems at the start and end of TB treatment and (ii) whether referral mechanisms for further care were functional. There were 603 patients registered with drug-susceptible TB who started TB treatment: 84% were symptomatic, 14% had diabetes, 14% had high blood pressure, 19% smoked cigarettes, 10% drank excess alcohol and in 45% the 6 min walking test (6MWT) was abnormal. Five patients were identified with mental health disorders. There were 586 (97%) patients who successfully completed TB treatment six months later. Of these, 18% were still symptomatic, 12% had diabetes (the remainder with diabetes failed to complete treatment), 5% had high blood pressure, 5% smoked cigarettes, 1% drank excess alcohol and 25% had an abnormal 6MWT. Referral mechanisms for the care of comorbidities and determinants worked well except for mental health and pulmonary rehabilitation for disability. There is need for more programmatic-related studies in other countries to build the evidence base for care of TB-related conditions and disability.

Empanelment of the Population to the Primary Medical Care Institution of Sri Lanka: A Mixed-Methods Study on Outcomes and Challenges.

The registration of individuals with designated primary medical care institutions (PMCIs) is a key step towards their empanelment with these PMCIs, supported by the Primary Health Care System Strengthening Project in Sri Lanka. We conducted an explanatory mixed-methods study to assess the extent of registration at nine selected PMCIs and understand the challenges therein. By June 2021, 36,999 (19.2%, 95% CI-19.0-19.4%) of the 192,358 catchment population allotted to these PMCIs were registered. At this rate, only 50% coverage would be achieved by the end of the project (December 2023). Proportions of those aged <35 years and males among those registered were lower compared to their general population distribution. Awareness activities regarding registration were conducted in most of the PMCIs, but awareness in the community was low. Poor registration coverage was due to a lack of dedicated staff for registration, misconceptions of health care workers about individuals needing to be registered, reliance on opportunistic or passive registration, and lack of monitoring mechanisms; these were further compounded by the COVID-19 pandemic. Moving forward, there is an urgent need to address these challenges to improve registration coverage and ensure that all individuals are empaneled before the close of the project for it to have a meaningful impact.

Outcomes and Challenges in Noncommunicable Disease Care Provision in Health Facilities Supported by Primary Health Care System Strengthening Project in Sri Lanka: A Mixed-Methods Study.

The Primary Healthcare System Strengthening Project in Sri Lanka focuses on improving noncommunicable disease (NCD) care provision at primary medical care institutions (PMCIs). We conducted an explanatory mixed-methods study to assess completeness of screening for NCD risk, linkage to care, and outcomes of diabetes/hypertension care at nine selected PMCIs, as well as to understand reasons for gaps. Against a screening coverage target of 50% among individuals aged ≥ 35 years, PMCIs achieved 23.3% (95% CI: 23.0-23.6%) because of a lack of perceived need for screening among the public and COVID-19-related service disruptions. Results of investigations and details of further referral were not documented in almost half of those screened. Post screening, 45% of those eligible for follow-up NCD care were registered at medical clinics. Lack of robust recording/tracking mechanisms and preference for private providers contributed to post-screening attrition. Follow-up biochemical investigations for monitoring complications were not conducted in more than 50% of diabetes/hypertension patients due to nonprescription of investigations by healthcare providers and poor uptake among patients because of nonavailability of investigations at PMCI, requiring them to avail services from the private sector, incurring out-of-pocket expenditure. Primary care strengthening needs to address these challenges to ensure successful integration of NCD care within PMCIs.

Primary Health Care System Strengthening Project in Sri Lanka: Status and Challenges with Human Resources, Information Systems, Drugs and Laboratory Services.

A Primary Healthcare-System-Strengthening Project (PSSP) is implemented by the Ministry of Health, Sri Lanka, with funding support from the World Bank for providing quality care through primary medical care institutions (PMCIs). We used an explanatory mixed-methods study to assess progress and challenges in human resources, drug availability, laboratory services and the health management information system (HMIS) at PMCIs. We conducted a checklist-based assessment followed by in-depth interviews of healthcare workers in one PMCI each in all nine provinces. All PMCIs had medical/nursing officers, but data entry operators (44%) and laboratory technicians (33%) were mostly not available. Existing staff were assigned additional responsibilities in PSSP, decreasing their motivation and efficiency. While 11/18 (61%) essential drugs were available in all PMCIs, buffer stocks were not maintained in >50% due to poor supply chain management and storage infrastructure. Only 6/14 (43%) essential laboratory investigations were available in >50% of PMCIs, non-availability was due to shortages of reagents/consumables and lack of sample collection−transportation system. The HMIS was installed in PMCIs but its usage was sub-optimal due to perceived lack of utility, few trained operators and poor internet connectivity. The PSSP needs to address these bottlenecks as a priority to ensure sustainability and successful scale-up.

Quality, Equity and Partnerships in Mixed Methods and Qualitative Research during Seven Years of Implementing the Structured Operational Research and Training Initiative in 18 Countries.

Introduction: Qualitative studies are often inadequately reported, making it difficult to judge their appropriateness for decision making in public health. We assessed the publication characteristics and quality of reporting of qualitative and mixed-method studies from the Structured Operational Research and Training Initiative (SORT IT), a global partnership for operational research capacity building. Methods: A cross-sectional analysis of publications to assess the qualitative component using an adapted version of the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist. Results: In 67 publications involving 18 countries, 32 journals and 13 public health themes, 55 were mixed-methods studies and 12 were qualitative studies. First authorship from low-and-middle-income (LMIC) countries was present in 64 (96%), LMIC last authorship in 55 (82%), and female first authorship in 30 (45%). The mean LMIC institutions represented per publication was five (range 1-11). Sixty-three (94%) publications were open access. Reporting quality was graded as 'good' to 'excellent' in 60 (89%) publications, 'fair' in five (8%) and 'poor' in two (3%). Conclusion: Most SORT IT publications adhered to COREQ standards, while supporting gender equity in authorship and the promotion of LMIC research leadership. SORT IT plays an important role in ensuring quality of evidence for decision making to improve public health.

Real-Time Operational Research: Case Studies from the Field of Tuberculosis and Lessons Learnt.

Real-time operational research can be defined as research on strategies or interventions to assess if they are feasible, working as planned, scalable and effective. The research involves primary data collection, periodic analysis during the conduct of the study and dissemination of the findings to policy makers for timely action. This paper aims to illustrate the use of real-time operational research and discuss how to make it happen. Four case studies are presented from the field of tuberculosis. These include (i) mis-registration of recurrent tuberculosis in Malawi; (ii) HIV testing and adjunctive cotrimoxazole to reduce mortality in TB patients in Malawi; (iii) screening TB patients for diabetes mellitus in India; and (iv) mitigating the impact of COVID-19 on TB case detection in capital cities in Kenya, Malawi and Zimbabwe. The important ingredients of real-time operational research are sound ethics; relevant research; adherence to international standards of conducting and reporting on research; consideration of comparison groups; timely data collection; dissemination to key stakeholders; capacity building; and funding. Operational research can improve the delivery of established health interventions and ensure the deployment of new interventions as they become available, irrespective of diseases. This is particularly important when public health emergencies, including pandemics, threaten health services.

Operational Research to Assess the Real-Time Impact of COVID-19 on TB and HIV Services: The Experience and Response from Health Facilities in Harare, Zimbabwe.

When COVID-19 was declared a pandemic, there was concern that TB and HIV services in Zimbabwe would be severely affected. We set up real-time monthly surveillance of TB and HIV activities in 10 health facilities in Harare to capture trends in TB case detection, TB treatment outcomes and HIV testing and use these data to facilitate corrective action. Aggregate data were collected monthly during the COVID-19 period (March 2020-February 2021) using EpiCollect5 and compared with monthly data extracted for the pre-COVID-19 period (March 2019-February 2020). Monthly reports were sent to program directors. During the COVID-19 period, there was a decrease in persons with presumptive pulmonary TB (40.6%), in patients registered for TB treatment (33.7%) and in individuals tested for HIV (62.8%). The HIV testing decline improved in the second 6 months of the COVID-19 period. However, TB case finding deteriorated further, associated with expiry of diagnostic reagents. During the COVID-19 period, TB treatment success decreased from 80.9 to 69.3%, and referral of HIV-positive persons to antiretroviral therapy decreased from 95.7 to 91.7%. Declining trends in TB and HIV case detection and TB treatment outcomes were not fully redressed despite real-time monthly surveillance. More support is needed to transform this useful information into action.

Assessing the Real-Time Impact of COVID-19 on TB and HIV Services: The Experience and Response from Selected Health Facilities in Nairobi, Kenya.

There was concern that the COVID-19 pandemic would adversely affect TB and HIV programme services in Kenya. We set up real-time monthly surveillance of TB and HIV activities in 18 health facilities in Nairobi so that interventions could be implemented to counteract anticipated declining trends. Aggregate data were collected and reported monthly to programme heads during the COVID-19 period (March 2020-February 2021) using EpiCollect5 and compared with monthly data collected during the pre-COVID period (March 2019-February 2020). During the COVID-19 period, there was an overall decrease in people with presumptive pulmonary TB (31.2%), diagnosed and registered with TB (28.0%) and in those tested for HIV (50.5%). Interventions to improve TB case detection and HIV testing were implemented from August 2020 and were associated with improvements in all parameters during the second six months of the COVID-19 period. During the COVID-19 period, there were small increases in TB treatment success (65.0% to 67.0%) and referral of HIV-positive persons to antiretroviral therapy (91.2% to 92.9%): this was more apparent in the second six months after interventions were implemented. Programmatic interventions were associated with improved case detection and treatment outcomes during the COVID-19 period, suggesting that monthly real-time surveillance is useful during unprecedented events.

Assessing the Impact of COVID-19 on TB and HIV Programme Services in Selected Health Facilities in Lilongwe, Malawi: Operational Research in Real Time.

When the COVID-19 pandemic was announced in March 2020, there was concern that TB and HIV programme services in Malawi would be severely affected. We set up real-time monthly surveillance of TB and HIV activities in eight health facilities in Lilongwe to see if it was possible to counteract the anticipated negative impact on TB case detection and treatment and HIV testing. Aggregate data were collected monthly during the COVID-19 period (March 2020-February 2021) using an EpiCollect5 application and compared with monthly data collected during the pre-COVID-19 period (March 2019-February 2020); these reports were sent monthly to programme directors. During COVID-19, there was an overall decrease in persons presenting with presumptive pulmonary TB (45.6%), in patients registered for TB treatment (19.1%), and in individuals tested for HIV (39.0%). For presumptive TB, children and females were more affected, but for HIV testing, adults and males were more affected. During COVID-19, the TB treatment success rate (96.1% in pre-COVID-19 and 96.0% during COVID-19 period) and referral of HIV-positive persons to antiretroviral therapy (100% in pre-COVID-19 and 98.6% during COVID-19 period) remained high and largely unchanged. Declining trends in TB and HIV case detection were not redressed despite real-time monthly surveillance.

Quality, Equity and Utility of Observational Studies during 10 Years of Implementing the Structured Operational Research and Training Initiative in 72 Countries.

Introduction: Observational studies are often inadequately reported, making it difficult to assess their validity and generalizability and judge whether they can be included in systematic reviews. We assessed the publication characteristics and quality of reporting of observational studies generated by the Structured Operational Research and Training Initiative (SORT IT). Methods: A cross-sectional analysis of original publications from SORT IT courses. SORT IT is a global partnership-based initiative aimed at building sustainable capacity for conducting operational research according to country priorities and using the generated evidence for informed decision-making to improve public health. Reporting quality was independently assessed using an adapted version of 'Strengthening the Reporting of Observational Studies in Epidemiology' (STROBE) checklist. Results: In 392 publications, involving 72 countries, 50 journals, 28 publishers and 24 disease domains, low- and middle-income countries (LMICs) first authorship was seen in 370 (94%) and LMIC last authorship in 214 (55%). Publications involved LMIC-LMIC collaboration in 90% and high-income-country-LMIC collaboration in 87%. The majority (89%) of publications were in immediate open access journals. A total of 346 (88.3%) publications achieved a STROBE reporting quality score of >85% (excellent), 41 (10.4%) achieved a score of 76-85% (good) and 5 (1.3%) a score of 65-75% (fair). Conclusion: The majority of publications from SORT IT adhere to STROBE guidelines, while also ensuring LMIC equity and collaborative partnerships. SORT IT is, thus, playing an important role in ensuring high-quality reporting of evidence for informed decision-making in public health.

Does the Structured Operational Research and Training Initiative (SORT IT) continue to influence health policy and/or practice?

BACKGROUND: The Structured Operational Research and Training Initiative (SORT IT) is a successful model of integrated operational research and capacity building with about 90% of participants completing the training and publishing in scientific journals. OBJECTIVE: The study aims at assessing the influence of research papers from six SORT IT courses conducted between April 2014 and January 2015 on policy and/or practice. METHODS: This was a cross-sectional mixed-method study involving e-mail based, self-administered questionnaires sent to course participants coupled with telephone/Skype/in-person responses from participants, senior facilitators and local co-authors of course papers. A descriptive content analysis was performed to generate themes. RESULTS: Of 71 participants, 67 (94%) completed the course. A total of 67 papers (original research) were submitted for publication, of which 61 (91%) were published or were in press at the censor date (31 December 2016). Among the 67 eligible participants, 65 (97%) responded to the questionnaire. Of the latter, 43 (66%) research papers were self-reported to have contributed to a change in policy and/or practice by the course participants: 38 to a change in government policy or practice (26 at the national level, six at the subnational level and six at the local/hospital level); four to a change in organisational policy or practice; and one study fostered global policy development. CONCLUSION: Nearly two-thirds of SORT IT course papers contributed to a change in policy and/or practice as reported by the participants. Identifying the actual linkage of research to policy/practice change requires more robust methodology, in-depth assessment and independent validation of the reported change with all concerned stakeholders.

Building Global Capacity for Conducting Operational Research Using the SORT IT Model: Where and Who?

SETTING: Research capacity is weakest in low and middle-income countries (LMICs) where operational research is highly relevant and needed. Structured Operational Research and Training Initiative (SORT IT) courses have been developed to train participants to conduct and publish operational research and influence policy and practice. Twenty courses were completed in Asia, Africa, Europe and the South Pacific between 2009 and 2014. OBJECTIVES: In the 20 completed SORT IT courses, to assess where the research was conducted, who was trained, who became facilitators in subsequent courses and course outcomes. DESIGN: A cohort study of completed SORT IT courses. RESULTS: There were 236 participants (41% female) including 64 nationalities who conducted research in 59 countries, mostly from Asia and Africa (mean course duration = 9.7 months). Most participants (68%) were from government health programs and non-governmental agencies. A total of 213(90%) participants completed all milestones successfully with 41(19%) becoming subsequent course facilitators, 88% of whom were from LMICs. Of 228 manuscripts submitted to scientific journals, 197(86%) were either published or in press; in 86%, the principal investigator (first author) was a LMIC national. Papers were published in 23 scientific journals (impact factor 0.5-4.4) and covered 21 disease categories (median publication time = 5.7 months). Published papers (186) had 94,794 cumulative article views/downloads. Article views/downloads for immediate open access articles were double those from closed access journals. CONCLUSION: The SORT IT model has been effective in training personnel to produce relevant operational research in LMICs. It merits continued commitment and support for further scale-up and development.