The study was conducted at primary healthcare facilities i.e., rural health centres in three districts of Punjab, Pakistan. These districts were selected systematically to geographically represent the south, central, and northern regions of Punjab and included one district from each region i.e., Jhang (Central), Muzaffargarh (South), and Sargodha (North). One rural health centre was randomly selected from every district to be included in the study. The study was conducted between November 2023 and May 2024.
Study Design
This study employs the care cascade framework (Table 1), a sequential multi-method approach which utilises quantitative and qualitative data collected from primary and secondary sources (to be published separately). This was selected because the utilisation of known approaches, such as the ADAPT guidance (13) and the Medical Research Council framework for complex interventions (14) in Pakistan is hindered owing to two key factors in our experience: lack of available evidence and resource constraints. Hence, we have utilised a simplified tool inspired by these international guidelines, but based more on empirical evidence and is not heavily reliant on specialised research expertise.
A core expert group (CEG) comprising both technical and managerial experts and moderated by a senior public health professional was formulated to lead the process. A Technical Working Group (TWG) was established by the Directorate General Health Services, Punjab, with representation from international organisations such as the World Health Organisation, UK Health Security Agency, as well as the Ministry of National Health Services, Regulations and Coordination, Government of Punjab.
The CEG formulated actionable components of the intended intervention, which we labelled as “care tasks”. In this process, intervention components were conceptually broken down through implementation science perspective to list tasks for delivering and managing the care. An implementation research logic model (15) was used for this activity. The proceedings, as well as the final list of the care tasks were reviewed and endorsed by the TWG. These care tasks were subsequently used as pre-defined themes for every step of the study.
Following the care task listing, the care cascade framework has three distinct but interrelated steps; learn, understand, and synthesise/inform the intervention, each step being informed by and expanding on the previous step. All three of these steps are employed to contextualise the key actionable components of the intervention i.e., the care tasks.
The first step is to learn about the existing landscape by reviewing the available evidence as well as the facility settings. The second step is to understand key contextual nuances through engagement with relevant stakeholders. This is followed by synthesising the findings and informing the components of the intervention. The main activities conducted to implement these steps were as follows:
- Literature review was conducted to learn from the global and national experiences of improving antibiotic prescription practices, as well as conducting antimicrobial stewardship activities at primary healthcare settings
- Facility review was done to understand the care setting and practices
- Key informant interviews were carried out to have a better understanding of the gaps identified by the healthcare staff, as well as from the literature and facility review regarding the care setting and practices at the RHC for the management of acute URTI and diarrhoea
- Focus group discussions (FGDs) were aimed at discussing and finding solutions to the problems identified from the key informant interviews and the facility review.
Table 1: Care-task framework
Data Collection
For the literature review, searches were conducted on multiple databases, including PubMed, Scopus, and CINAHL, using designated keywords targeting the established care tasks (and/or synonyms or MeSH words). In addition, Google Scholar was also used for grey literature. The duration for the literature search included all publications in the English language published from January 2005 to December 2023. Initial searches were conducted according to the systematic literature review methodology (16) which was followed by a more targeted literature review (17) conducted through a rapid literature review technique. Reviewing the bibliographies of all the identified literature was helpful for further identifying relevant materials.
The facility review was done through onsite observation and review of facility records. Two mid-level researchers visited one randomly selected rural health centre in every district. It was conducted using a structured checklist developed to specifically address the key areas and gaps identified through the literature review relevant to the listed care tasks.
The activities and interactions of RHC staff with patients, as well as the facility records of a single working day, were reviewed by both researchers and findings were noted in the checklist independently. The findings of both researchers were then reviewed by a senior public health professional and any discrepancy was discussed with both researchers, establishing a common consensus.
The facility review was complemented by key-informant interviews (KII) at the RHCs. The design of the interview guides for the KIIs was informed by the learnings from literature and facility review focused on the pre-defined care tasks. Separate interview guides were developed for health care providers and patients, which were then pilot tested (18) for ensuring phrasing consistency as well as construct validity and necessary changes were made for refinement. Purposive sampling method (19) was used to identify relevant stakeholders for the KIIs. The KIIs were conducted in Urdu with healthcare providers (n=6) and patients with diarrhoea and/or acute respiratory infections (n=6). The interviews were conducted by a mid-level qualitative researcher with a background in public health who was accompanied by a note taker (20). The duration of KIIs varied from 30 – 40 minutes per interview and were audio recorded and transcribed verbatim.
A total of 8 FGDs were organised with homogenous groups of 4-6 representatives from relevant stakeholder groups which included: Doctors, allied staff, district level managers, male and female patients (separately) with diarrhoea and/or acute upper respiratory infections, male and female patients (separately) with experience of using mobile applications for healthcare, and community representatives. The FGDs lasted between 60 – 75 minutes and were conducted by trained qualitative researchers in the local language to facilitate participation. Two mid-level researchers moderated the discussion and took notes.
Data Analysis
All the findings from every step were populated into the respective sections of the care task framework.
For the literature review, the evidence was consolidated into summary findings according to the guidelines provided by Snyder (21). The observations from the health facility were compared, and summary learnings were subsequently populated in the relevant matrix cells.
For qualitative data collected in KIIs and FGDs, deductive thematic analysis (22) was conducted with care tasks as pre-defined themes. The transcripts from the KIIS and FGDs were independently analysed by two mid-level researchers, and codes, categories, and themes were developed from the transcripts. Afterwards, a senior researcher reviewed the analysis process and brought consensus to the process after consultation with both researchers. Lastly, the thematic findings from KIIs and FGDs were populated into the relevant column of the care cascade framework.
Once the framework was populated, the findings from all methods were synthesised by the core expert group to formulate operational and technical recommendations for informing the healthcare delivery. These recommendations were then reviewed, endorsed, and modified according to the guidance by TWG.
Ethical Considerations
This study was approved by the Ethics Advisory Group (EAG) of the Association for Social Development (ASD) (Reference number: ASD-EAG-24-001a). Written informed consent was obtained from all participants (attached as an appendix). The confidentiality and privacy of all interviewees and participants were respected in data analysis and reporting.
FINDINGS:
The Core Expert Group (CEG), using the care-cascade framework, outlined the essential care tasks involved in providing outpatient management of URTI and diarrhoea at the RHCs, including: 1) patient consultation and laboratory testing; 2) drug prescription; 3) drug dispensing; and 4) patient education/ counselling.
Patient consultation and laboratory testing
Review of the literature and facilities showed that there were no guidelines available at the RHCs to aid the consultation of patients presenting with URTI or diarrhoea (23). History taking and physical examination of the patients was only informed by the doctors’ core medical training and hands-on experience of care delivery. The average OPD consultation time was around 2-3 minutes per patient. The consultation rooms mostly had multiple patients present at a time and lacked an examination couch or privacy curtains. Interviews revealed that this resulted in compromised patient privacy during history taking and physical examination.
“I found it very hard to explain my symptoms to the doctor openly because many other people who were present during the consultation were listening. The doctor was a male, which also made me shy.”
Female patient with diarrhoea - KII
According to the literature, there are minimal lab services and non-existent drug sensitivity testing at the primary care level in Pakistan (24) (25). RHCs had a modest-sized laboratory room (accommodating 4-5 people at a time). Commonly available tests at the RHC laboratory included blood glucose, complete blood picture (CBC) and chest X-Ray (CXR) at a subsidised rate. For tests not available at the RHC, patients were referred to the tehsil headquarter (THQ) or the district headquarter (DHQ) hospitals. Interviews showed that tests are mostly prescribed to patients in case the symptoms do not subside with the initial treatment. Patients also preferred minimal testing prior to treatment due to their health condition and financial constraints.
We do not have any clear guidelines for proper history taking and clinical examination to diagnose correctly without test results, and to decide whether or not to prescribe antibiotics”
Male doctor - KII
In light of the challenges, the discussions with the managers, providers and the patients led to valuable solutions. A clear need for contextualised protocols/guidelines for the diagnosis and management of URTI and diarrhoea was highlighted.
“The doctors are experienced; however, a large influx of patients and minimal consultation time is a risk for inconsistent care. Therefore, there is a need for standardised consultation guidelines to be in place. We need clear, practical tools to streamline clinical decision-making.”
Provincial Program Manager, Health Services - FGD
Some of the focus areas to be addressed in the guidelines/protocols were to clinically diagnose URTI and diarrhoea, to clinically differentiate between viral and bacterial infections and to sensitise the healthcare staff on patients’ privacy during consultation. The managers and doctors further emphasised the need for training of the healthcare staff in case any such protocols/guidelines are put in place.
“Significant strengthening of RHC lab, including C/S services, is not a part of any current plan. Therefore, protocols, and doctors’ clinical skills and practices may be enhanced in terms of prescribing for empirical treatment.”
Manager - FGD
Drug prescription
The World Health Organisation (WHO) has published guidelines (AWaRe) for the appropriate prescription of antibiotics (26). Furthermore, clinical guidelines have been developed by the Medical Microbiology & Infectious Diseases Society of Pakistan (MMIDSP) for the management of common infectious diseases (27). However, hospitals lack guidelines on appropriate antibiotic use or implementation mechanisms in Pakistan (23). The review of facilities also found no specific protocols/guidelines regarding drug prescription for URTI and diarrhoea available at RHCs. A limited range of antibiotics was available for procurement by the RHCs to cover most infections (see table 2 for commonly available antibiotics at RHCs). Surveillance data of antibiotics at the RHC level was limited; hence, the stocking of antibiotics was not informed as per the actual need of the facilities. Drugs are procured from the district health authority through a requisition sent from the main drug store that provides medicines as per need to the OPD on a daily basis. A strict budget was allocated to the RHCs for the procurement of antibiotics with limited flexibility of reallocation. The antibiotics to be stocked were selected as per need, and the quantity was determined as per the seasons (e.g., antibiotics for respiratory infections are stocked in larger quantities during the winter season). The majority of patients got prescribed ≥1 drug, and about two-thirds of all prescriptions contained antibiotics.
Table 2: Common available antibiotics at RHCs
|
Generic name
|
Dosage
|
|
Amoxicillin
|
500mg
|
|
Co-amoxiclav
|
625mg, 156.25mg/ml
|
|
Azithromycin
|
500mg
|
|
Cefixime
|
500mg, 100mg/5ml, 200mg/5ml
|
|
Ciprofloxacin
|
500mg, 125mg
|
|
Metronidazole
|
500mg, 400mg, 200mg/5ml, 120mg/ml
|
|
Co-trimoxazole
|
160/800mg, 80/400mg/5ml
|
Review of the literature revealed that the prescription of antibiotics is influenced by multiple provider and patient-related factors. The provider-related factors suggested fear of medicolegal problems if the patient’s health deteriorated, not losing patients (for profits), pressure of time and workload, prevailing culture, lack of patient follow-up, self-experience (hit and trial), copying others, and information from pharmaceutical companies, induction training, Continuous Medical Education (CMEs), and conferences (28). The patient-related factors included resistance and denial about the self-limiting nature of their illness, as well as easy access to antibiotics from other doctors or over the counter if not prescribed (29) (30). As these considerations were further explored through the facility review and key-informant interviews, it was found that the doctors claimed to prescribe antibiotics appropriately based on their clinical acumen; yet, prescription was found to be influenced by drug availability, drug cost, physicians’ preferences, and the patient’s social status and preferences.
“Patients often don’t know whether a drug is an antibiotic or not. However, they do recognise the names or appearances of the drugs that they feel have worked for them previously. So, they say, for example, ‘give me Amoxil’ or ‘prescribe me that green colored capsule.’”
Key Informant Interview – Male doctor
The managers and providers underscored a need for protocols/guidelines for appropriate antibiotic prescription for URTI and diarrhoea (based on clinical examination) and to treat the disease within given resources (i.e., available drugs). They also suggested a need for antibiotic selection guidelines informed by antibiotic resistance patterns.
Drug dispensing
Review of facilities found that there are designated stations for dispensing of drugs (for both males and females). A dispenser (usually male) dispenses the drugs and maintains records. The drugs (particularly antibiotics) are usually dispensed for up to two days, and patients are asked to visit the RHC again for the remaining dose. When further explored, it was found that dispensing drugs for two days relates to limited stock of drugs, risk of side-effects and uncertain patient adherence to drug intake. The interviews showed that the patients were inadequately counselled regarding the importance of collecting the remaining dose, and therefore, did not always adhere to this protocol.
In the FGDs conducted, the dispensing of a complete course of antibiotics was encouraged. However, in given circumstances, it was suggested that adherence to treatment despite partial dispensing should be enhanced through standardised patient education on responsible consumption (i.e., dosage, treatment duration, follow-up and not getting antibiotics prescribed from elsewhere). Since in RHC settings, dispensers educate the patients regarding the prescribed treatment, it was suggested that they should be enabled to provide the standardised education to the patients. The importance of continued support mechanisms to ensure the provision of quality care was also emphasised.
“We should explore the possibility of dispensing a full course of antibiotics to everyone. Currently, we dispense the full course of antibiotics (i.e., for 7 days) to only those who we deem absolutely necessary.”
Female doctor - FGD
Patient education
A review of the literature showed the significance of patient education in the case of respiratory infections (31) and diarrhoea (32) regarding disease prevention and reducing the misuse of antibiotics. Educating patients through digital smartphone applications is considered one of the most effective mechanisms for improving their knowledge, medication or treatment adherence, satisfaction, and clinical outcomes (33). The facilities’ review showed that there were no standardised protocols/messages available for education or reporting complaints of URTI and diarrhoea patients. However, patient education for other diseases, e.g., tuberculosis, diabetes etc. was carried out by the RHC dispensers instead of doctors due to heavy patient load and limited consultation time. No mechanism was currently in place for the patients to access knowledge regarding care or report complaints.
“If patients have an emergency and want to reach out, there are only two ways; either they visit the RHC directly or call Rescue 1122 (ambulance service)”
Female doctor - KII
The dispensers felt a need for having a standardised mechanism in place for on-site education and further suggested that patients should be efficiently educated through easy-to-understand and concise messages. They further stressed the importance of a source to make information accessible at home. Since the doctors have limited consultation time per patient, one of the strategies suggested to address this issue was to train the dispenser to educate the patients. The managers expressed a need for a mechanism to not only educate but also engage patients in making care more responsive to their needs.
Since the time is limited, it would be better if the information was available at home where people could read it themselves. Only that it should be understandable and easy to understand because there would be no healthcare staff at home to help us with that.
Female patient with URTI - FGD
The use of healthcare mobile applications for engaging patients was found feasible and easily accessible. The existing users of these apps found some features to be significantly useful including audio assistance throughout the app and pictorial depiction of the messages for less literate people. Some users expressed that being able to access information with compromised internet access will further improve useability. A structured platform for participation was advocated by the community representatives who had previously been a part of such platforms where they were able to generate possible solutions, in collaboration with the doctors, in response to challenges reported by patients regarding care delivery for other conditions e.g., hypertension.
"We’ve had a proper platform to sit together before, like with the hypertension project, people actually shared what was going wrong, and we came up with practical solutions along with the doctors. That kind of space really helps. We need something similar now too."
Community significant - FGD
Synthesise and inform the intervention package
There is a need for guidelines to inform the diagnosis and treatment of URTI, and diarrhoea, given the limited facilities and skills available at the RHC level. Some of the key areas that should be covered in the guidelines are clinical diagnosis of bacterial and viral infections (given the absence of lab diagnostics) as well as its severity; the required treatment; and follow up. A tailor-made desk-aide for the doctors to help them diagnose and treat efficiently will cover these details.
Educating patients and engaging them to make care responsive to their needs is also an essential component in AMR response. The dispenser who is already counselling patients for other diseases such as TB and NCDs, should also educate URTI and diarrhoea patients on care i.e., prevention and treatment. To enable the dispenser to provide standardised education, a counselling flipbook will be developed. This will include easily understandable pictorial-aided messages focusing on: understanding URTI/diarrhoea disease; conservative management of the disease; prevention; and risk of AMR (including what causes it and how to avoid it). Further to educating patients at facilities, a need for a source of knowledge that is accessible even after the facility visit was also identified. This will be addressed through a digital mobile application that will not only make knowledge accessible to patients at all times but will also provide them with awareness about their rights as patients.
In addition to educating patients, the application will also be able to support the engagement of patients in making care responsive to their needs. The application will provide the patients with a platform to report care and social challenges. The care challenges will be addressed through patient-provider forums that will be conducted at each facility (based on care challenges reported at the respective facilities), and the social challenges will be addressed through peer support videos that will be incorporated within the application.
A need for a proper patient safety mechanism was reflected, which was addressed through a recommendation to develop a digital platform for follow up care and enabling patients to report medical emergencies, if any.
Successful implementation of these intervention components will require adequate training of healthcare staff i.e., doctors and allied staff (i.e., dispensers). Therefore, there is a need for training manuals that covers all intervention components in detail with clear instructions on roles. The doctors will be trained on efficient diagnosis; treatment; and prescription writing (i.e., diagnosis, drug, dose and duration). The allied staff will be trained on counselling the patients and guiding patients about installation as well as the use of the mobile app and WhatsApp bot.
Therefore, the intervention package will consists of: desk-aide for doctors, training manuals for doctors and allied staff, a mobile app for patient engagement and a “WhatsApp bot” for patient safety.