Research Report.

EXECUTIVE SUMMARY
Background: In 2016, the government of Nepal endorsed the WHO PEN protocol and piloted the program in two districts: Ilam and Kailali in 2017. By FY 2018/19 (FY 2075/76 BS), the program was expanded to 31 districts; and to all 77 districts by 2021. Although previous studies have reported gaps in NCD service delivery and preparedness, no study has been conducted to evaluate PEN implementation at a national level. Hence, this study was undertaken with three major aims. First, the study evaluates the integration of PEN service delivery and care provision in primary health care settings. Second, the study identifies the facilitators and barriers to PEN implementation from the perspectives of health authorities (HA), health service providers (HSPs), and NCD clients. Third, the study compares the trends in NCD morbidities reported by the PEN implemented and non-implemented districts in Nepal. Methods: We utilized mixed method approach for this study: (a) Health facility survey: We randomly selected 105 primary healthcare facilities (PHCs and HPs) using multistage stratified random sampling (step 1: selection of all provinces, step 2: random selection of two PEN implemented districts from each province, step 3: random selection of primary healthcare facilities). We assessed status of PEN services in the primary healthcare facilities using a structured questionnaire based on the WHO Service Availability and Readiness Assessment (SARA) and PEN reference manual; (b) Observation: We observed patients and provider’s interaction on the day of data collection to assess the adherence to PEN protocols at the health facilities. (c) Qualitative interviews: we conducted 23 key informant interviews (KIIs) with HAs at different levels of the government, and in-depth interviews (IDIs) with HSPs (47 IDIs) at the primary healthcare level and NCD clients (35 IDIs); (d) Secondary data analysis: we obtained HMIS 9.3 NCD data from the Department of Health Services (DOHS) to analyze the trend of NCD morbidities reported by the sampled PEN implemented districts and compared them with non-implemented districts which were randomly sampled from other remaining districts. The primary data collected through health facility assessments were entered into the KOBO Toolbox and imported into Excel for data cleaning. Data were exported and analyzed in STATA after adjusting for the sampling weights. The findings of the study were presented using descriptive statistics frequencies and percentages after adjusting for sampling weights. The qualitative interview recordings were transcribed verbatim and coded using a codebook which was developed using an inductive and deductive approach. Data were coded and analyzed using the thematic approach in Dedoose software. The findings of qualitative and quantitative have been triangulated to present the obtained results. Key Findings: PEN implementation situation: Â Human resources: Sixty-nine percent of the health facilities had at least one PEN trained health worker. Team-based approach among the health workers of the PHCCs was found while performing daily tasks. Â Diagnostic tests and procedures: Regarding Protocol-1 related diagnostic test and procedures, only 35 percent of the health facilities had blood sugar test and 17 percent had urine ketone test available. Only 7 percent had lipid profile test available. Regarding Protocol-3 related diagnostic test and procedures, peak flow test and x-ray was provided in only 6 percent and 4 percent of the health facilities, respectively. Spirometry was available in 7 percent of the PHCCs and none of the health posts. Regarding Protocol-4 related diagnostic test and procedures, cryotherapy and mammogram was not available in any health facilities. VIA service was available in 9 percent of the health facilities and Pap smear test was available in almost none of the health facilities.
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 Medicines and equipment: Protocol-1 medicines like amlodipine and metformin were available in half of the health facilities surveyed. Metformin was available in 89 percent of the PHCCs and 60 percent of the health facilities in urban area compared to 48 percent in HPs and 43 percent of the health facilities in rural area. Protocol-1 related equipment like BP apparatus and weighing machine were available in 96 percent and 90 percent of the health facilities, respectively. The availability of other equipment included in the PEN protocol-1 was low. Glucometer was available in 43 percent, strips were available in 26 percent, and urine ketone test strips were available in 17 percent of the health facilities. Of the Protocol-3 drugs, salbutamol was available in majority (81%) of the health facilities surveyed whereas less than 1 percent of health facilities had beclomethasone. Of the Protocol-3 equipment, peak flow meter was available in only 12 percent, and nebulizer was available in 43 percent of the health facilities. Protocol-4 equipment like examination table was available in majority (81%) of the health facilities surveyed whereas none of the health facilities had cryotherapy units. Speculum was available in more than half (63%) of the health facilities.  Guidelines: Eighteen percentage of health facilities had PEN guideline available. The guideline was more common in PHCCs (34%) compared to HPs (17%).  Information system: All health facilities reported to had HMIS recording register and regular reporting. Less than half (48%) had an online reporting system in place. Only 20 percent of the health facilities had NCD registers, 15 percent had NCD monthly reporting form, and 18 percent had NCD OPD card.  Monitoring and supervision: Overall, the monitoring and supervision visits in the health facilities from all three levels of government was low.  Finances: Some of the health facilities (7%) received financial support from non-governmental organizations, service charge (5%) and social health insurance (3%). Adherence to PEN protocol  Adherence to PEN protocol-1: A total of 136 NCD clients were observed to assess adherence of HSPs’ to PEN Protocol 1. Out of 136 observed cases, 65 were managed by PEN trained and 71 by PEN-untrained HSPs. PEN trained HSP examined NCD-related symptoms in 80 percent of the clients observed, compared to 77 percent of the clients by untrained health service providers. Family history of NCD assessment was low in both groups. CVD risk estimation was conducted by only PEN trained HSPs, however only on 8 percent of the clients. Among diabetes clients, feet examination was done among 14 percent of clients examined by PEN trained HSP and 7 percent of clients seen by untrained HSPs. Foot care was advised in 19 percent and 7 percent of NCD clients seen by PEN trained and untrained HSPs, respectively.  Adherence to PEN protocol-2: A total of 182 clients receiving counseling sessions were observed. Out of 182 observed cases, 92 were managed by PEN trained and 90 by PEN-untrained HSPs. Unhealthy dietary behaviors were the most commonly assessed risk factors in NCD clients by the PEN trained (27%) and untrained (16%) HSPs. Assessment of tobacco consumption done among PEN trained HSPs (17%) compared to untrained HSPs (12%). Counseling on salt restriction was substantially higher (41% vs. 21%) in PEN trained HSPs. NCD clients were poorly advised to increase the consumption of fruits and vegetables by both PEN trained (3%) and untrained HSPs (1%).  Adherence to PEN protocol-3: A total of 23 clients with CRDs while receiving NCD services from the health facilities were observed. A higher proportion of PEN trained HSPs asked for the presence of CRD-specific symptoms such as cough (73% vs. 63%) and chronic breathlessness (87% vs. 13%) compared to untrained HSPs. None of the HSPs, PEN trained or untrained, performed Peak Expiratory Flow Rate (PEFR) tests in CRD clients. Higher proportion of CRD clients managed by the PEN trained HSPs received advice compared to the clients attended by the untrained HSPs.
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Monthly trend of NCD cases:  Hypertension: There was no difference in trend of reported hypertension prevalence per 100,000 population between PEN-implemented and non-implemented districts until Aug 2018, then reported cases were higher from PEN-implemented district.  Diabetes: The reported prevalence of diabetes mellitus cases increased for PEN-implemented districts from May/Jun 2018 (Jestha 2075) as compared to PEN non-implemented districts.  COPD: There was not much difference in reported cases of COPD per 100,000 population between PEN-implemented and non-implemented districts. There was slightly higher reporting from October 2018 to August 2019, then after the reporting was not different between PEN implemented and non-implemented districts.  Asthma: Throughout this period (from Jul/Aug 2016 to Jun/Jul 2021), the reported asthma cases were slightly higher among PEN-implemented districts as compared to non-implemented districts. During the COVID-19 first wave (March 2020) and second wave (April 2021), there was a decreasing trend in reported hypertension, diabetes mellitus, COPD and asthma cases in both PEN-implemented and non-implemented districts.  Cervical cancer: Mainly, PEN non-implemented districts reported a higher number of suspected cervical cancer cases as compared to PEN-implemented districts. In non-implemented districts, around the first (March 2020) and second (April 2021) COVID-19 wave, we observed a decreasing trend in reported suspected cervical/uteri cancer cases.  Breast cancer: There was not much difference in reported cases of suspected breast cancer between PEN implemented and non-implemented districts, except in June 2019 that shows a peak in reported cases in PEN non-implemented districts which was much higher than PEN implemented district. This was due to reporting from Lalitpur district that reported 88 percent of suspected breast cancer cases from non-implemented district. Facilitators and barriers to PEN implementation  Health service providers and health authority’s perspective: From the health authorities and health service provider’s perspective, facilitating factors for PEN included: (a) social health insurance (b) peer discussion sessions (c) decentralization of power to the local government (d) availability of a standard guideline as a reference (e) existence of other NCD related programs and (f) PEN training. The major barriers included: (a) inadequate medical supplies (b) inadequate human resource (c) excessive workload of existing human resources (d) inadequate NCD recording and reporting tools (e) double reporting (f) low priority and insufficient budget (g) effect of COVID-19 (h) inadequate PEN/NCD specific monitoring and supervision (i) inadequate community engagement for PEN/ NCD services and awareness and (j) health illiteracy.  NCD clients perspective: From the patient’s perspective, the major facilitators for PEN service utilization were: (a) acceptability (b) accessibility (c) accessibility and availability of medicine and services (d) less waiting time (e) positive experience in interaction with service providers (f) improvement in health condition (g) self-efficacy (h) client’s symptoms (i) knowledge of diseases consequence and management (j) self-awareness and (k) support from peers and family members. The major barriers included: (a) unavailability of medicine and services (b) inaccessibility and unaffordability (c) inadequate health information from service providers (d) poor adherence to the advice from HSPs (e) misconception about disease and treatment (f) lack of awareness and (g) impact of COVID-19.
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 Conclusion: The study reveals several gaps in PEN service provision in all levels of health systems including inadequate budget, human resources, medicines, equipment, NCD recording and reporting forms, supervision and monitoring, and financing. PEN guidelines use is also limited by service providers at the primary healthcare facilities. Findings from the study, including the factors affecting the success or failure of the program, will be used for improving the performance as well as to plan the further scale-up of the PEN program in Nepal. Government should strengthen PEN implementation through training all staff in PHCs and HP through onsite or online platform; train a cadre of health providers to share tasks and delivery NCD care (such as counselling, monitoring of BP, glucose, medicine, community awareness) at the community level; ensure adequate finances and set up of diagnostic tests, supplies, equipment and medicine; expand social health insurance to all health facilities; make protocols visible and easier to use; integrated NCD information into HMIS and DHIS-2; systematically supervise and monitor PEN program; and extend community based activities to raise awareness and strengthen linkages with clients.