Development of Quality Indicators for Hypertension Management at the Primary Health Care Level in South Africa

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The aim of this study was to develop quality indicators for hypertension management at the PHC level to improve the quality of care and patient outcomes. A 2-round RAND/UCLA Appropriateness Method was used to develop clear, appropriate, and feasible evidence-based quality indicators for hypertension. In round one, a 9-point scale was used by an 11-member panel to rate clarity and appropriateness of 102 hypertension quality indicator statements grouped under 9 dimensions of quality hypertension management, using an online MS Excel® spreadsheet. In round two, 9 of the same panellists discussed all indicators and rated their appropriateness and feasibility during a remote online, interactive face-to-face MS Teams® meeting. Statements rated ≥7-9 with agreement were defined as either appropriate or feasible. The panel rated 46 hypertension quality indicator statements ≥7-9 with agreement for the appropriate and feasible measurement of the management of hypertension: monitoring (n=16), review (n=5), lifestyle advice (n=9), tests (n=7), intermediate outcomes (n=6), referrals (n=2) and practice/facility structures (n=1). No indicator statements were rated both appropriate and feasible for measuring blood pressure levels and treatment. If applied, these indicators would improve monitoring and management of patients with hypertension, patient outcomes, data quality and result in a more efficient use of scarce resources. This study can be replicable for improving care of other non-communicable diseases in South Africa and Africa. Health sciences/Diseases Health sciences/Health care Hypertension quality of care indicators primary care South Africa Figures Figure 1 INTRODUCTION Provision of quality healthcare to patients with diagnosed hypertension at the primary health care (PHC) level in South Africa is mandatory and enshrined in the Constitution of the country ( 1 ). The South African government is responsible for the overall health care system and the PHC level within the public health system, covering approximately 80% of the population ( 2 ). South Africa has implemented multiple initiatives to improve the quality of the management of non-communicable diseases (NCDs), specifically hypertension and type 2 diabetes mellitus ( 3 ). This includes a National Strategic Plan for the Management of Non-Communicable Diseases, 2022–2027 ( 3 ). Alongside this, a policy and guidelines on monitoring and enforcing adherence to medicines for chronic use in all health facilities ( 4 ). In 2021, a National User Guide on the Prevention and Treatment of Hypertension in Adults at PHCs included interventions to strengthen the monitoring and management of patients with hypertension in the country ( 5 ). Recently, the National Health Insurance Bill was intended to pave the way to universal health coverage for all citizens in South Africa ( 6 , 7 ). Such interventions are important given rising rates of NCDs in South Africa as well as an increase in the number of patients with joint co-morbidities, including both infectious diseases and NCDs ( 8 , 9 ). What remains unknown is the quality of care that patients with hypertension are currently receiving at the PHC level in South Africa ( 3 , 10 – 11 ). Whilst it has been suggested that patients with diagnosed hypertension are not receiving recommended care, and are often not at target treatment goals, this is exacerbated by possible suboptimal quality of healthcare services at the PHC level ( 8 ). Combined with this, there is often a lack of antihypertensive medicines being routinely available within PHC facilities ( 12 ). As a result, making the control of hypertension a public health challenge in South Africa. However, there is not enough data available on the quality of care that patients with hypertension receive at the PHC level in South Africa to fully assess the quality of care currently provided to guide the implementation of policy initiatives ( 13 ). In addition, how to use the available data to improve the quality of care provided alongside the outcomes of patients with hypertension. Poor quality of care, coupled with a lack of data to improve care, contribute to avoidable high morbidity and mortality due to hypertension ( 14 ). Table 1 summarises what is already known about hypertension management in the public PHC level in South Africa and the gaps in knowledge this study addresses. Table 1 Summary Table What is known about quality of care for patients with hypertension What this study adds in the quality of care for patients with hypertension • Evidence-based guidelines for management of hypertension are available ( 3 – 5 , 15 ). • No locally agreed indicators to measure the quality of care in the management of hypertension at the PHC level in South Africa ( 17 ). • There are concerns with the quality of care and control of blood pressure amongst patients diagnosed and managed for hypertension at the PHC level in South Africa ( 8 , 13 ). • Provide appropriate and feasible quality indicators that can be tested for implementation to measure and track quality of care for hypertension at the PHC level. • Lay foundation for future development of appropriate and feasible quality indicators for management of other non-communicable diseases in Africa. • Provide all stakeholders a platform to agree on suitable measures of quality of care, making it easy for acceptability and implementation. The lack of data on the quality of care provided to patients with hypertension at the PHC level in South Africa is associated with the lack of processes and tools to measure the quality of care ( 16 ). Consequently, it is important for the Ministry of Health in South Africa to strengthen existing quality improvement initiatives to reduce the rising burden of NCDs in the country by putting in place structures and processes to collect reliable and comparable data. This is because sustained quality improvement within the current public health care system, and the provision of appropriate care, remains problematic in South Africa ( 13 ). Quality indicators measure whether the evidence-based guidelines regarding the current management of hypertension is being implemented ( 13 ). However, in South Africa there is no agreed minimum set of standardized indicators to assess the current quality of care and to monitor progress towards attainment of the hypertension objectives set out in these initiatives ( 17 ). Quality indicators can provide data to monitor the achievement of programme outcomes ( 17 – 19 ). Alongside this, developing and testing quality indicators as part of a multiple approach is key to strengthening health programmes and enhancing the quality and efficiency of clinical services ( 11 , 20 – 21 ). This has implications not only for the management of hypertension in South Africa but also across Africa given current concerns ( 22 ). The lack of a well-defined quality indicator framework for the management and monitoring of patients with diagnosed hypertension on treatment at PHC level undermines the aim of Universal Health Coverage and to reduce high morbidity and mortality due to hypertension in South Africa, which is a key target for the National Strategic Plan for NCDs ( 13 ). Consequently, the aim of this study was to develop quality indicators for hypertension management and monitoring at the PHC level that can be implemented in South Africa. MATERIALS AND METHOD This study used a modified RAND/UCLA Appropriateness Method (RAM), initially developed by RAND Heath staff in collaboration with clinicians at the University of California at Los Angeles (UCLA) (23). The RAM is an internationally recognized formal group consensus modified Delphi technique that allows for the development of consensus among experts where no previous consensus exists, with individual opinions forming a refined, aggregated and group opinion. This methodology has been used extensively, for example, in the UK for the construction of a patient safety toolkit for general medical practice (24). It uses a series of sequential steps involving evidence synthesis, clinical scenario or indicator development, panellist selection, two-round rating process and the analysis of the results. Synthesis of possible quality indicators The authors, co-ordinated by the lead author (EMR), conducted a rapid evidence assessment to review the international evidence-based clinical guidelines as well as national action plans for the management of chronic NCDs, specifically hypertension. The purpose was to identify, synthesise and develop quality indicator statements from international and national evidence-based guidelines for the management of diagnosed hypertension in adult patients. The indicator statements were identified and categorised into different dimensions of the quality of care from the quality standards guidelines for the management of hypertension at the PHC level, sourced from international and national guidelines and the National Strategic Plan for Non-communicable Diseases in South Africa (see Table 2) (3,5,15,25-26). RAND/UCLA Appropriateness Method (RAM) The RAM was used to establish the clarity, appropriateness and feasibility of the quality indicator statements that were derived from the literature review as part of an ongoing indicator development and testing protocol (27). Panellists for the RAM were selected to create a multidisciplinary panel reflecting the range of health care professionals (HCPs) currently involved in the day-to-day management of people with diagnosed hypertension in South Africa with a mix of international/national expertise as well as HCPs working in PHC facilities in South Africa. Panellists were recruited using nominations from professional associations, national, provincial and districts health departments and institutions of higher learning, including tertiary hospitals. All panellists were involved in both rounds of the RAM. Panellists were sent a copy of the synthesised evidence synthesis, an instruction sheet including definitions of terms and the rating scale before completing the two appropriateness rating rounds. In both rounds, the panellists had the same number of hypertension quality indicator statements, grouped within 9 dimensions for their consideration and rating, based on the different sections of hypertension management guidelines nationally and internationally (3, 5,15, 25-26). The dimensions consisted of “monitor, review, lifestyle advice, blood pressure levels, treatment, tests, intermediate outcomes and practice/facility” quality indicator statements. Consensus procedure The RAM was completed in two rounds. The first round consisted of an online MS Excel® rating spreadsheet that was sent to the panellists by email, requesting them to rate the list of hypertension quality indicator statements on a 9-point integer scale, separately for clarity and appropriateness. Panellists were invited to provide alternative wordings for the indicators or suggest new indicators if wished. The second round was an online face-to face MS Teams® meeting chaired by two chairpersons: a clinical chairperson (NNN) and the methodologist chairperson (SC) with experience in the use of consensus methods in different settings (28). An MS Excel® spreadsheet was used to collate data from the completed first-round rating sheets with the median rating for each indicator calculated for clarity and for appropriateness. The frequency distribution of each response on the 1–9 scale for each indicator for clarity and appropriateness was calculated. The level of agreement for each indicator was calculated according to the conventional RAM method of percentage of ratings within the same tertile as the median (<25% as ’agreement’; ≥33% in both 1-3 and 7-9 ranges as ’disagreement’; all indicators without consensus [either agreement or disagreement] as ’equivocal’)’ (23,29). For Round 2, first-round data were used to create personalised rating sheets for each panellist showing the median for each indicator for clarity and appropriateness, the frequency distribution of all panel ratings across the 9-point integer scale for each indicator so that the panellist could see the first-round ratings of appropriateness from the full panel (confidentially to each panellist) and a reminder of how they rated each indicator in Round 1. Five days prior to the online meeting, panellists were sent their personalised rating sheet, an instruction sheet, source of evidence for the quality indicator statements, a summary of Round 1 and an introduction presentation explaining the RAM and purpose of Round 2. With agreement from all panellists, the panel was sent a short biography of each panellist. The two chairs (SMC and NNN) of the second-round face-to-face online meeting also received an MS Excel® rating spreadsheet, showing how each panellist had rated each indicator in Round 1. In Round 2, panellists rated the indicators for appropriateness again and for feasibility in terms of the PHC level settings in South Africa using a 9-point scale for appropriateness and feasibility (See Figure 1 for explanation of the 9-point rating scale and panel rating scale consensus). In applying the rating scale, panellists were instructed to consider an adult patient (≥ 18 years) with a confirmed diagnosis of hypertension being managed by an ‘average clinician under average circumstances in the PHC setting in South Africa’. An MS Excel® spreadsheet was used to collate data from the completed second-round rating sheets with the median rating for each indicator calculated for appropriateness and for feasibility. The frequency distribution of each response on the 1–9 scale for each indicator for appropriateness and feasibility was calculated. The level of agreement for each indicator was calculated according to the conventional RAM method of percentage of ratings within the same tertile as the median (<25% as ’agreement’; ≥33% in both 1-3 and 7-9 ranges as ’disagreement’; all indicators without consensus [either agreement or disagreement] as ’equivocal’) (23,29). The aim of the consensus was to classify potential hypertension indicators as appropriate and feasible in the context of PHC in South Africa. Appropriate being defined as whether something would be an appropriate next step clinically for the ‘average’ patient in the ‘average’ PHC/ambulatory setting, seeing the ‘average’ HCP in South Africa (25,27). On the other hand, feasibility being defined as whether something would be feasible to implement, and data would be available for the ‘average’ patient in the ‘average’ PHC/ambulatory setting seeing the ‘average’ HCP, in terms of human resources, financial and other restraints in the context of South Africa (25,27). All data analyses and findings are based on Round 2 of the RAM. Ethical Approval Ethical approval for the study was received from the Sefako Makgatho University Research Ethics Committee (SMUREC/P/93/2023:PG). Permission to conduct the study was obtained from the Department of Health in Limpopo Province (LP_2023-04-020). This study adhered to all the prescribed conditions of the Protection of Private Information Act, 4 of 2013 (POPIA) and Promotion of Access to Information Act, 2 of 2000 (PAIA) as amended. RESULTS Panel composition The panel in round 2 was composed of nine members, including four family physicians, one cardiologist, one pharmacist, two clinical pharmacists and one clinical nurse practitioner. All panellists were involved in the management of hypertension patients as well as contributing to development and review of hypertension guidelines, either at an international, national, provincial or district level. Synthesised quality indicator statements There were 102 quality indicator statements listed and grouped under 9 different dimensions of quality of care on the MS Excel® rating spreadsheet. The indicator statements were identified from the quality standards guidelines for management of hypertension at PHC level, sourced from international and national guidelines and National Strategic Plan for Non-Communicable Diseases in South Africa (see Table 2). No panellist provided alternative wordings for the indicators or suggested new indicators. The full list containing all 102 statements is available on request from the authors. Quality indicator statements Table 3 summarises the results of the 102 Round 2 indicator ratings. The panellists concluded on 46 quality indicator statements for hypertension in the PHC level in South Africa. There was agreement for 46 (45.1%) indicators, with 0 (0%) rated with disagreement and 46 (45.1%) with an equivocal rating. An appropriate next step was identified in 10 (9.8%) indicators. For all indicators, there was agreement that no action was inappropriate. Only statements rated ≥ 7 with agreement were considered appropriate or feasible (Table 2). Under appropriateness, there were two statements rated 6 with agreement, and one statement rated 5 with agreement. Under feasibility, there were 9 statements rated 6 with agreement. There were 7 and 42 statements rated equivocal under appropriateness and feasibility respectively. Table 4 shows the list of 46 statements for which the panel reached consensus in terms of their appropriateness and feasibility for hypertension management at the PHC level. Panellists did not find a single indicator being appropriate and feasible for the dimensions ‘patient blood pressure and patient treatment’. All the indicators about ‘advice about lifestyle and intermediate outcome’ were rated as appropriate and feasible. Most of the indicators under the dimensions ‘monitoring’ and ‘review of patients’ and indicators under the dimension ‘tests’ were found appropriate and feasible. Patient blood pressure level All four quality indicators which categorised blood pressure levels as normal, mild, moderate, and severe hypertension were rated appropriate; however, three were not seen as feasible and one as equivocal. Example of these indicators is ‘The % of patients in the practice/unit/facility who has blood pressure ≤ 140/90 mmHg’, which is seen as equivocal. The three indicator statements about the percentage of patients in the facility that have mild, moderate, and severe hypertension were not rated feasible. Patient treatment Most of the 17 indicator statements about the percentage of patients in different steps of the stepwise treatment without compelling indications, or with a specific condition such as stroke in the last 3 months, were rated appropriate, but in all the statements their feasibility was seen as equivocal. An example of these indicators is ‘The % of patients in the practice/unit/facility who are on the treatment of hypertension with angina in the last 3 months’. DISCUSSION We believe this is the first time that the RAND/UCLA Appropriateness Method has been used in South Africa to develop hypertension quality indicator statements from the hypertension management guidelines. From 102 guideline-based quality indicators, 45.1% of the quality indicators were rated both appropriate and feasible with agreement to improve the management of patients with diagnosed hypertension at the PHC level in South Africa. Lifestyle and behavioural changes can lead to improved hypertension outcomes in mild hypertension without the need for antihypertensive treatment, and even in resistant hypertension (30), and it is important to maintain advice on a healthy lifestyle during drug therapy. Lifestyle advice is also important as previous research reported that 16.6% of people with hypertension indicated that financial difficulties were the cause of challenges in accessing medicines (31). Monitoring intermediate outcomes in the management of hypertension is an important intervention in improving quality of care and patient outcomes (11,20-21,32). They assist with increasing the number of patients who are at the treatment goal of a blood pressure ≤140/90 mmHg and those currently not yet at their goal as well as informing future interventions for individual patients currently not at their treatment goals (8). Whilst the panel agreed that all the indicators under the dimension ‘blood pressure levels’ were appropriate, they agreed that it was not feasible to determine the number or percentage of all patients with blood pressure above the target goal (>140/90 mmHg) in the context of PHC in South Africa. They were also equivocal on one of the indicators under this dimension, which was about determining the number or percentage of patients with controlled blood pressure (≤140/90 mmHg). The decisions of the panellists on the indicators under the dimension of ‘blood pressure levels’ can be considered appropriate, considering that the panellists found all the indicators in the dimension of ‘intermediate outcome’ as appropriate and feasible. All the indicators under the dimension ‘intermediate outcome’ are about the number or percentage of patients with a blood pressure of ≤ 140/90 mmHg with no adverse or medicine reactions in patients who are already on hypertension medication in different steps of the algorithm of hypertension management. The data on the indicators under the dimension ‘intermediate outcome’ can indirectly lead to the number of patients who are not at treatment target goals (blood pressure level). Consequently, the agreement of the panellists that the use of the indicators under the ‘blood pressure level’ is not feasible. Their decision may also have been based on the evidence that measuring quality requires measuring positive outcomes, count, or percentage of patients with a blood pressure of ≤ 140/90 mmHg in this case, and not vice versa (8). The panel found most of the indicators under the dimension ‘treatment’ and ‘blood pressure level’ appropriate but either with equivocal feasibility or not feasible. Further work will be required to modify the indicators especially those encompassing adherence to the stepwise approach to the management of hypertension. Indicators rated appropriate and feasible under the dimension ‘referral’ may assist in identifying the data for which indicators, under the dimensions ‘blood pressure levels’ and ‘treatment’, were intended for. Based on the assumption that guidelines in the management of hypertension at the PHC level are adhered to, the indicators under the dimension ‘referrals’ would provide the measure in which the indicators under ‘blood pressure level’ and ‘treatment’ dimensions were intended for. Most of the indicators under the dimensions ‘monitoring’ and ‘review of patients’ were found appropriate and feasible. These indicators underpin the importance of recording activities and measurements that should be undertaken with the patient during the visit and provide the basis for quality of health care actions addressed in other dimensions. This is also important as it facilitates population level data collection with accurate data, which can then be used to inform future interventions needed to improve and sustain the quality of care at the PHC level in South Africa. Most of the indicators under the dimension ‘tests’ were also found appropriate and feasible. This is imperative as these indicators are about recording of the tests that were performed with patients. Consequently, providing a measure of whether the prescribed tests are conducted within the prescribed frequency amongst the hypertension patients at the PHC level in South Africa. Conclusions and implications for patient care As mentioned, hypertension currently exerts a considerable health and economic burden on South Africa (13), with evidence that patients are currently not receiving the necessary evidence-based care in PHC facilities (5,12). Moreover, the focus on monitoring patients with hypertension in South Africa is an imperative given the low levels of reported medication adherence (33), the fact that one‑third of patients often do not receive all their antihypertensive medicines from PHC facilities due to supply chain issues and generally poor access to quality care (7,12). Applying the care stated in these indicators would improve the outcomes, including their quality of life, amongst patients with confirmed diagnosis of hypertension being treated at the PHC level in South Africa. The indicators and framework for hypertension management from this study can be replicated for the management of type 2 diabetes mellitus and other NCDs in South Africa, which is a priority of the National Department of Health (3). Substandard quality of care contributes to the global disease burden and unmet health need in the population (3,17). This is especially important given the high prevalence of hypertension among people with diabetes in Africa and the urgent need for an integrated differentiated service delivery (22). Better monitoring and management of patients with hypertension will lead to improved quality of care, reduced avoidable harm, morbidity and mortality and will result in a more efficient use of scarce health care resources. Consequently, our findings have implications not only for key stakeholder groups in South Africa to improve the care of patients with hypertension in the public system, but also across Africa. This study used the RAM which promotes robust, credible, and valid hypertension quality indicators as this methodology combines the available scientific evidence and expert opinion in the management of hypertension (28, 34). It is a practical, real-world method, designed to identify appropriate clinical steps tailored to patient needs and grounded in everyday practice of practitioners and facilities (23). Unlike other consensus techniques such as the Delphi Technique, the RAM incorporates interactive discussion of indicator statements between panellists in Round 2. In addition, a multidisciplinary panel of experts, all involved in the day-to-day management of people with hypertension, and from different provinces of South Africa, were used in the development of possible indicators. The mixed sample of panellists resulted in a wide variation of relevant views to hypertension management, including members of the South African hypertension guidelines, to enhance the possible utility of considered indicators. Two people chaired the panel meeting, a clinical and a methodologist expert, to add strength to the process and findings. Online RAM panel meetings have been used successfully, in part in response to restrictions imposed by the COVID-19 pandemic, with online meetings at a reduced cost (34). Hypertension is the leading modifiable cardiovascular disease risk factor in South Africa and this study provides a possible solution to the current lack of quality measuring tools of healthcare provided to patients with hypertension at the PHC level, by identifying 46 evidence-based quality indicators specifically tailor-made to suit South African public PHC level settings. In addition, in view of the overlap in risk factors, prognosis, and treatment of hypertension and diabetes, agreed indicators also provide a platform to improve the monitoring of the management of patients with diabetes in PHCs based on the hypertension monitoring template. This approach can subsequently be used to develop quality indicators for all other high priority NCDs in South Africa and elsewhere in Africa. The use of the RAM has enabled researchers and practitioners to develop a preliminary but clearly outlined framework of indicators for the monitoring and management of people with hypertension receiving care from PHC in South Africa. Sound and reliable information is the foundation of decision-making in healthcare and appropriate next clinical steps for people with confirmed NCDs (18). The WHO, World Bank Group and OECD have identified five foundational elements critical to delivering quality health care services as being health care workers; health care facilities; medicines, devices, and other technologies; information systems; and financing (17). It is imperative to develop and apply a tested hypertension management framework that is congruent to these foundational elements in South Africa as well as Africa as a whole, to enhance the potential utility of applying the indicators. Outcomes from consensus techniques have face or content validity but the next step of the ongoing indicator development and testing protocol will be to test the 46 developed hypertension quality indicators for their data feasibility, reliability, and validity. In addition, to determine what implementation strategies might be needed in terms of workforce, facilities and medicines supply to apply the indicators at the PHC level in South Africa. Testing will also consider the clinimetric properties of the indicators to assess their value as measurement instruments as well as assess the appropriateness of hypertension management in the context of routine PHC/ambulatory care practice in South Africa, including the availability of routine data (35). Declarations Data Availability Statement Please note that additional data are available from the corresponding author on request. Acknowledgments We would like to appreciate all the panellists who contributed with their expertise during Round 1 and Round 2 of the RAND/UCLA Appropriateness Method process. Sefako Makgatho Health Sciences University is thanked for granting ethical approval for this study and the South African National Research Foundation (NRF) (UID No. 129079)) for funding this study. Author Contributions EMR, JCM, SMC and BG conceptualised the study, wrote the protocol, and prepared for the RAND/UCLA Appropriateness Method panel meeting. 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NICE quality and outcomes framework indicators. 2020. https://www.nice.org.uk/standards-and-indicators/index/All/hypertension . Pan American Health Organisation (PAHO). Monitoring and evaluation framework for hypertension control programs. Washington, DC. 2018. https://iris.paho.org/bitstream/handle/10665.2/34877/PAHONMH18001_eng.pdf?sequence=6&isAllowed=y . Accessed 16 Mar 2024. Campbell SM, Kontopantelis E, Hannon K, Burke M, Barber A, Lester HE. Framework and indicator testing protocol for developing and piloting quality indicators for the UK quality and outcomes framework. BMC Fam Pract. 2011; 12: 85 (2011). https://doi.org/10.1186/1471-2296-12-85 . Jünger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017; 31(8):684–706. doi: 10.1177/0269216317690685 . Tsang JY, Murray J, Kingdon E, Tomson C, Hallas K, Campbell S et al. Guidance for post-discharge care following acute kidney injury: an appropriateness ratings evaluation. BJGP Open. 2020; 25;4(3): bjgpopen20X101054. doi: 10.3399/bjgpopen20X101054 . American Heart Association. Changes you can make to manage high blood pressure. Fighting back against the 'silent killer'. https://www.heart.org/en/health-topics/high-blood-pressure/changes-you-can-make-to-manage-high-blood-pressure#:~ :text=Make%20changes%20that%20matter%3A&text=Enjoy%20regular%20physical%20activity,Quit%20smoking World Health Organization. Access to NCD medicines: emergent issues during the COVID-19 pandemic and key structural factors. Geneva. 2023 (b). Licence: CC BY-NC-SA 3.0 IGO. Available from: https://iris.who.int/bitstream/handle/10665/366528/9789240069442-eng.pdf?isAllowed=y&sequence=1 . Accessed on 09 Dec 2023. Donabedian A. Evaluating the quality of medical care. 1966. Milbank Q. 2005; 83(4):691–729. doi: 10.1111/j.1468-0009.2005.00397.x . Shin J, Konlan KD. Prevalence and determinants of medication adherence among patients taking antihypertensive medications in Africa: A systematic review and meta-analysis 2010–2021. Nurs Open. 2023; 10(6):3506–3518. doi: 10.1002/nop2.1613 . Broder MS, Gibbs SN, Yermilov I. An Adaptation of the RAND/UCLA Modified Delphi Panel Method in the Time of COVID-19. J Healthc Leadersh. 2022; 20:14:63–70. doi: 10.2147/JHL.S352500 . Thilly N, Pereira O, Schouten J, Hulscher ME, Pulcini C. Proxy indicators to estimate appropriateness of antibiotic prescriptions by general practitioners: a proof-of-concept cross-sectional study based on reimbursement data, north-eastern France 2017. Euro Surveill. 2020; 25(27):1900468. doi: 10.2807/1560-7917 . Additional Declarations There is NO conflict of interest to disclose. Supplementary Files Table1SummaryTable20240409.pdf Table2Sourcesofdataontheindicatorstatements.pdf Table3Hypertensionqualityindicatorstatementsperdimension.pdf Table4Listofhypertensionmanagementindicatorsratedappropriateandfeasible.pdf Cite Share Download PDF Status: Published Journal Publication published 14 Oct, 2024 Read the published version in Journal of Human Hypertension → Version 1 posted Editorial decision: revise 28 May, 2024 Review # 2 received at journal 24 May, 2024 Review # 1 received at journal 10 May, 2024 Reviewer # 2 agreed at journal 01 May, 2024 Reviewer # 1 agreed at journal 27 Apr, 2024 Reviewers invited by journal 20 Apr, 2024 Editor assigned by journal 16 Apr, 2024 Submission checks completed at journal 10 Apr, 2024 First submitted to journal 09 Apr, 2024 Unknown event 08 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Rampamba","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0klEQVRIiWNgGAWjYBCDBAb2BiBlYEGKFp4DIC0SpGiRSADRRGjRnX346eaCmm15/DOfX93wo0CCgb+9OwGvFrNzaWa3Zxy7XSxxO6fsZg/QYRJnzm7Ar+UMg9ltHrbbiQ23c9Ju8AC1GEjkEtLC/u02z7/bifNvnkm7+Yc4LTxmt3nbbiduuMF+7DaRtvCU3Z7Zd7vY8EwO220ZAwkeIvzCvu12wbfbeXLHjz+7+eaPjRx/ey9+LSDADKF4DMAkQeVIWtgfEKV6FIyCUTAKRh4AAHSkTjVun/+xAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-3492-9104","institution":"Sefako Makgatho Health Sciences Univerty","correspondingAuthor":true,"prefix":"","firstName":"Enos","middleName":"","lastName":"Rampamba","suffix":""},{"id":293554294,"identity":"213a8258-eddb-42c0-beda-ebbc798dd19e","order_by":1,"name":"Johanna Meyer","email":"","orcid":"https://orcid.org/0000-0003-0462-5713","institution":"Sefako Makgatho Health Sciences 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15:18:18","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":41710,"visible":true,"origin":"","legend":"","description":"","filename":"Table3Hypertensionqualityindicatorstatementsperdimension.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4231707/v1/861c674c48d7d6af212287f9.pdf"},{"id":55528807,"identity":"bf0936ea-9274-4291-a873-34d0637e77bd","added_by":"auto","created_at":"2024-04-29 15:18:18","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":62505,"visible":true,"origin":"","legend":"","description":"","filename":"Table4Listofhypertensionmanagementindicatorsratedappropriateandfeasible.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4231707/v1/4e37a84d5ea80b1b2beb8bdc.pdf"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose.","formattedTitle":"\u003cp\u003eDevelopment of Quality Indicators for Hypertension Management at the Primary Health Care Level in South Africa\u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eProvision of quality healthcare to patients with diagnosed hypertension at the primary health care (PHC) level in South Africa is mandatory and enshrined in the Constitution of the country (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). The South African government is responsible for the overall health care system and the PHC level within the public health system, covering approximately 80% of the population (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). South Africa has implemented multiple initiatives to improve the quality of the management of non-communicable diseases (NCDs), specifically hypertension and type 2 diabetes mellitus (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). This includes a National Strategic Plan for the Management of Non-Communicable Diseases, 2022\u0026ndash;2027 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Alongside this, a policy and guidelines on monitoring and enforcing adherence to medicines for chronic use in all health facilities (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). In 2021, a National User Guide on the Prevention and Treatment of Hypertension in Adults at PHCs included interventions to strengthen the monitoring and management of patients with hypertension in the country (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Recently, the National Health Insurance Bill was intended to pave the way to universal health coverage for all citizens in South Africa (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Such interventions are important given rising rates of NCDs in South Africa as well as an increase in the number of patients with joint co-morbidities, including both infectious diseases and NCDs (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eWhat remains unknown is the quality of care that patients with hypertension are currently receiving at the PHC level in South Africa (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Whilst it has been suggested that patients with diagnosed hypertension are not receiving recommended care, and are often not at target treatment goals, this is exacerbated by possible suboptimal quality of healthcare services at the PHC level (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Combined with this, there is often a lack of antihypertensive medicines being routinely available within PHC facilities (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). As a result, making the control of hypertension a public health challenge in South Africa. However, there is not enough data available on the quality of care that patients with hypertension receive at the PHC level in South Africa to fully assess the quality of care currently provided to guide the implementation of policy initiatives (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). In addition, how to use the available data to improve the quality of care provided alongside the outcomes of patients with hypertension. Poor quality of care, coupled with a lack of data to improve care, contribute to avoidable high morbidity and mortality due to hypertension (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e summarises what is already known about hypertension management in the public PHC level in South Africa and the gaps in knowledge this study addresses.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSummary Table\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWhat is known about quality of care for patients with hypertension\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhat this study adds in the quality of care for patients with hypertension\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Evidence-based guidelines for management of hypertension are available (\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e\u0026bull; No locally agreed indicators to measure the quality of care in the management of hypertension at the PHC level in South Africa (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e\u0026bull; There are concerns with the quality of care and control of blood pressure amongst patients diagnosed and managed for hypertension at the PHC level in South Africa (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e).\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Provide appropriate and feasible quality indicators that can be tested for implementation to measure and track quality of care for hypertension at the PHC level.\u003c/p\u003e \u003cp\u003e\u0026bull; Lay foundation for future development of appropriate and feasible quality indicators for management of other non-communicable diseases in Africa.\u003c/p\u003e \u003cp\u003e\u0026bull; Provide all stakeholders a platform to agree on suitable measures of quality of care, making it easy for acceptability and implementation.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe lack of data on the quality of care provided to patients with hypertension at the PHC level in South Africa is associated with the lack of processes and tools to measure the quality of care (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Consequently, it is important for the Ministry of Health in South Africa to strengthen existing quality improvement initiatives to reduce the rising burden of NCDs in the country by putting in place structures and processes to collect reliable and comparable data. This is because sustained quality improvement within the current public health care system, and the provision of appropriate care, remains problematic in South Africa (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Quality indicators measure whether the evidence-based guidelines regarding the current management of hypertension is being implemented (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). However, in South Africa there is no agreed minimum set of standardized indicators to assess the current quality of care and to monitor progress towards attainment of the hypertension objectives set out in these initiatives (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Quality indicators can provide data to monitor the achievement of programme outcomes (\u003cspan additionalcitationids=\"CR18\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Alongside this, developing and testing quality indicators as part of a multiple approach is key to strengthening health programmes and enhancing the quality and efficiency of clinical services (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). This has implications not only for the management of hypertension in South Africa but also across Africa given current concerns (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe lack of a well-defined quality indicator framework for the management and monitoring of patients with diagnosed hypertension on treatment at PHC level undermines the aim of Universal Health Coverage and to reduce high morbidity and mortality due to hypertension in South Africa, which is a key target for the National Strategic Plan for NCDs (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Consequently, the aim of this study was to develop quality indicators for hypertension management and monitoring at the PHC level that can be implemented in South Africa.\u003c/p\u003e"},{"header":"MATERIALS AND METHOD","content":"\u003cp\u003eThis study used a modified RAND/UCLA Appropriateness Method (RAM), initially developed by RAND Heath staff in collaboration with clinicians at the University of California at Los Angeles (UCLA) (23). The RAM is an internationally recognized formal group consensus modified Delphi technique that allows for the development of consensus among experts where no previous consensus exists, with individual opinions forming a refined, aggregated and group opinion. This methodology has been used extensively, for example, in the UK for the construction of a patient safety toolkit for general medical practice (24). It uses a series of sequential steps involving evidence synthesis, clinical scenario or indicator development, panellist selection, two-round rating process and the analysis of the results.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSynthesis of possible quality indicators\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors, co-ordinated by the lead author (EMR), conducted a rapid evidence assessment to review the international evidence-based clinical guidelines as well as national action plans for the management of chronic NCDs, specifically hypertension. The purpose was to identify, synthesise and develop quality indicator statements from international and national evidence-based guidelines for the management of diagnosed hypertension in adult patients. \u0026nbsp;The indicator statements were identified and categorised into different dimensions of the quality of care from the quality standards guidelines for the management of hypertension at the PHC level, sourced from international and national guidelines and the National Strategic Plan for Non-communicable Diseases in South Africa (see Table 2) (3,5,15,25-26).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRAND/UCLA Appropriateness Method (RAM)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe RAM was used to establish the clarity, appropriateness and feasibility of the quality indicator statements that were derived from the literature review as part of an ongoing indicator development and testing protocol (27). Panellists for the RAM were selected to create a multidisciplinary panel reflecting the range of health care professionals (HCPs) currently involved in the day-to-day management of people with diagnosed hypertension in South Africa with a mix of international/national expertise as well as HCPs working in PHC facilities in South Africa. Panellists were recruited using nominations from professional associations, national, provincial and districts health departments and institutions of higher learning, including tertiary hospitals.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll panellists were involved in both rounds of the RAM. Panellists were sent a copy of the synthesised evidence synthesis, an instruction sheet including definitions of terms and the rating scale before completing the two appropriateness rating rounds. In both rounds, the panellists had the same number of hypertension quality indicator statements, grouped within 9 dimensions for their consideration and rating, based on the different sections of hypertension management guidelines nationally and internationally (3, 5,15, 25-26). The dimensions consisted of \u0026ldquo;monitor, review, lifestyle advice, blood pressure levels, treatment, tests, intermediate outcomes and practice/facility\u0026rdquo; quality indicator statements.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsensus procedure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe RAM was completed in two rounds. The first round consisted of an online MS Excel\u0026reg; rating spreadsheet that was sent to the panellists by email, requesting them to rate the list of hypertension quality indicator statements on a 9-point integer scale, separately for clarity and appropriateness. \u0026nbsp;Panellists were invited to provide alternative wordings for the indicators or suggest new indicators if wished. The second round was an online face-to face MS Teams\u0026reg; meeting chaired by two chairpersons: a clinical chairperson (NNN) and the methodologist chairperson (SC) with experience in the use of consensus methods in different settings (28).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAn MS Excel\u0026reg; spreadsheet was used to collate data from the completed first-round rating sheets with the median rating for each indicator calculated for clarity and for appropriateness. The frequency distribution of each response on the 1\u0026ndash;9 scale for each indicator for clarity and appropriateness was calculated. The level of agreement for each indicator was calculated according to the conventional RAM method of percentage of ratings within the same tertile as the median (\u0026lt;25% as \u0026rsquo;agreement\u0026rsquo;; \u0026ge;33% in both 1-3 and 7-9 ranges as \u0026rsquo;disagreement\u0026rsquo;; all indicators without consensus [either agreement or disagreement] as \u0026rsquo;equivocal\u0026rsquo;)\u0026rsquo; (23,29).\u003c/p\u003e\n\u003cp\u003eFor Round 2, first-round data were used to create personalised rating sheets for each panellist showing the median for each indicator for clarity and appropriateness, the frequency distribution of all panel ratings across the 9-point integer scale for each indicator so that the panellist could see the first-round ratings of appropriateness from the full panel (confidentially to each panellist) and a reminder of how they rated each indicator in Round 1. \u0026nbsp;Five days prior to the online meeting, panellists were sent their personalised rating sheet, an instruction sheet, source of evidence for the quality indicator statements, a summary of Round 1 and an introduction presentation explaining the RAM and purpose of Round 2. \u0026nbsp;With agreement from all panellists, the panel was sent a short biography of each panellist.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe two chairs (SMC and NNN) of the second-round face-to-face online meeting also received an MS Excel\u0026reg; rating spreadsheet, showing how each panellist had rated each indicator in Round 1. In Round 2, panellists rated the indicators for appropriateness again and for feasibility in terms of the PHC level settings in South Africa using a 9-point scale for appropriateness and feasibility (See Figure 1 for explanation of the 9-point rating scale and panel rating scale consensus).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn applying the rating scale, panellists were instructed to consider an adult patient (\u0026ge; 18 years) with a confirmed diagnosis of hypertension being managed by an \u0026lsquo;average clinician under average circumstances in the PHC setting in South Africa\u0026rsquo;.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAn MS Excel\u0026reg; spreadsheet was used to collate data from the completed second-round rating sheets with the median rating for each indicator calculated for appropriateness and for feasibility. The frequency distribution of each response on the 1\u0026ndash;9 scale for each indicator for appropriateness and feasibility was calculated. The level of agreement for each indicator was calculated according to the conventional RAM method of percentage of ratings within the same tertile as the median (\u0026lt;25% as \u0026rsquo;agreement\u0026rsquo;; \u0026ge;33% in both 1-3 and 7-9 ranges as \u0026rsquo;disagreement\u0026rsquo;; all indicators without consensus [either agreement or disagreement] as \u0026rsquo;equivocal\u0026rsquo;) (23,29).\u003c/p\u003e\n\u003cp\u003eThe aim of the consensus was to classify potential hypertension indicators as appropriate and feasible in the context of PHC in South Africa. Appropriate being defined as whether something would be an appropriate next step clinically for the \u0026lsquo;average\u0026rsquo; patient in the \u0026lsquo;average\u0026rsquo; PHC/ambulatory setting, seeing the \u0026lsquo;average\u0026rsquo; HCP in South Africa (25,27). On the other hand, feasibility being defined as whether something would be feasible to implement, and data would be available for the \u0026lsquo;average\u0026rsquo; patient in the \u0026lsquo;average\u0026rsquo; PHC/ambulatory setting seeing the \u0026lsquo;average\u0026rsquo; HCP, in terms of human resources, financial and other restraints in the context of South Africa (25,27).\u003c/p\u003e\n\u003cp\u003eAll data analyses and findings are based on Round 2 of the RAM.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval for the study was received from the Sefako Makgatho University Research Ethics Committee (SMUREC/P/93/2023:PG). \u0026nbsp;Permission to conduct the study was obtained from the Department of Health in Limpopo Province (LP_2023-04-020). This study adhered to all the prescribed conditions of the Protection of Private Information Act, 4 of 2013 (POPIA) and Promotion of Access to Information Act, 2 of 2000 (PAIA) as amended.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003ePanel composition\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe panel in round 2 was composed of nine members, including four family physicians, one cardiologist, one pharmacist, two clinical pharmacists and one clinical nurse practitioner. All panellists were involved in the management of hypertension patients as well as contributing to development and review of hypertension guidelines, either at an international, national, provincial or district level.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSynthesised quality indicator statements\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere were 102 quality indicator statements listed and grouped under 9 different dimensions of quality of care on the MS Excel\u0026reg; rating spreadsheet. The indicator statements were identified from the quality standards guidelines for management of hypertension at PHC level, sourced from international and national guidelines and National Strategic Plan for Non-Communicable Diseases in South Africa (see Table 2). No panellist provided alternative wordings for the indicators or suggested new indicators. The full list containing all 102 statements is available on request from the authors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuality indicator statements\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTable 3 summarises the results of the 102 Round 2 indicator ratings. The panellists concluded on 46 quality indicator statements for hypertension in the PHC level in South Africa. There was agreement for 46 (45.1%) indicators, with 0 (0%) rated with disagreement and 46 (45.1%) with an equivocal rating. An appropriate next step was identified in 10 (9.8%) indicators. For all indicators, there was agreement that no action was inappropriate. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOnly statements rated \u0026ge; 7 with agreement were considered appropriate or feasible (Table 2). Under appropriateness, there were two statements rated 6 with agreement, and one statement rated 5 with agreement. Under feasibility, there were 9 statements rated 6 with agreement. There were 7 and 42 statements rated equivocal under appropriateness and feasibility respectively. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 4 shows the list of 46 statements for which the panel reached consensus in terms of their appropriateness and feasibility for hypertension management at the PHC level. Panellists did not find a single indicator being appropriate and feasible for the dimensions \u0026lsquo;patient blood pressure and patient treatment\u0026rsquo;. All the indicators about \u0026lsquo;advice about lifestyle and intermediate outcome\u0026rsquo; were rated as appropriate and feasible. Most of the indicators under the dimensions \u0026lsquo;monitoring\u0026rsquo; and \u0026lsquo;review of patients\u0026rsquo; and indicators under the dimension \u0026lsquo;tests\u0026rsquo; were found appropriate and feasible.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePatient blood pressure level\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll four quality indicators which categorised blood pressure levels as normal, mild, moderate, and severe hypertension were rated appropriate; however, three were not seen as feasible and one as equivocal. \u0026nbsp;Example of these indicators is \u0026lsquo;The % of patients in the practice/unit/facility who has blood pressure \u0026le; 140/90 mmHg\u0026rsquo;, which is seen as equivocal. The three indicator statements about the percentage of patients in the facility that have mild, moderate, and severe hypertension were not rated feasible.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePatient treatment\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eMost of the 17 indicator statements about the percentage of patients in different steps of the stepwise treatment without compelling indications, or with a specific condition such as stroke in the last 3 months, were rated appropriate, but in all the statements their feasibility was seen as equivocal. An example of these indicators is \u0026lsquo;The % of patients in the practice/unit/facility who are on the treatment of hypertension with angina in the last 3 months\u0026rsquo;.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eWe believe this is the first time that the RAND/UCLA Appropriateness Method has been used in South Africa to develop hypertension quality indicator statements from the hypertension management guidelines. From 102 guideline-based quality indicators, 45.1% of the quality indicators were rated both appropriate and feasible with agreement to improve the management of patients with diagnosed hypertension at the PHC level in South Africa.\u003c/p\u003e\n\u003cp\u003eLifestyle and behavioural changes can lead to improved hypertension outcomes in mild hypertension without the need for antihypertensive treatment, and even in resistant hypertension (30), and it is important to maintain advice on a healthy lifestyle during drug therapy. Lifestyle advice is also important as previous research reported that 16.6% of people with hypertension indicated that financial difficulties were the cause of challenges in accessing medicines (31).\u003c/p\u003e\n\u003cp\u003eMonitoring intermediate outcomes in the management of hypertension is an important intervention in improving quality of care and patient outcomes (11,20-21,32). They assist with increasing the number of patients who are at the treatment goal of a blood pressure\u0026nbsp;\u0026le;140/90 mmHg and those currently not yet at their goal as well as informing future interventions for individual patients currently not at their treatment goals (8).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWhilst the panel agreed that all the indicators under the dimension \u0026lsquo;blood pressure levels\u0026rsquo; were appropriate, they agreed that it was not feasible to determine the number or percentage of all patients with blood pressure above the target goal (\u0026gt;140/90 mmHg) in the context of PHC in South Africa. They were also equivocal on one of the indicators under this dimension, which was about determining the number or percentage of patients with controlled blood pressure (\u0026le;140/90 mmHg). The decisions of the panellists on the indicators under the dimension of \u0026lsquo;blood pressure levels\u0026rsquo; can be considered appropriate, considering that the panellists found all the indicators in the dimension of \u0026lsquo;intermediate outcome\u0026rsquo; as appropriate and feasible. All the indicators under the dimension \u0026lsquo;intermediate outcome\u0026rsquo; are about the number or percentage of patients with a blood pressure of\u0026nbsp;\u0026le;\u0026nbsp;140/90 mmHg with no adverse or medicine reactions in patients who are already on hypertension medication in different steps of the algorithm of hypertension management. The data on the indicators under the dimension \u0026lsquo;intermediate outcome\u0026rsquo; can indirectly lead to the number of patients who are not at treatment target goals (blood pressure level). Consequently, the agreement of the panellists that the use of the indicators under the \u0026lsquo;blood pressure level\u0026rsquo; is not feasible. \u0026nbsp;Their decision may also have been based on the evidence that measuring quality requires measuring positive outcomes, count, or percentage of patients with a blood pressure of\u0026nbsp;\u0026le;\u0026nbsp;140/90 mmHg in this case, and not vice versa (8). \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe panel found most of the indicators under the dimension \u0026lsquo;treatment\u0026rsquo; and \u0026lsquo;blood pressure level\u0026rsquo; appropriate but either with equivocal feasibility or not feasible. Further work will be required to modify the indicators especially those encompassing adherence to the stepwise approach to the management of hypertension. Indicators rated appropriate and feasible under the dimension \u0026lsquo;referral\u0026rsquo; may assist in identifying the data for which indicators, under the dimensions \u0026lsquo;blood pressure levels\u0026rsquo; and \u0026lsquo;treatment\u0026rsquo;, were intended for. Based on the assumption that guidelines in the management of hypertension at the PHC level are adhered to, the indicators under the dimension \u0026lsquo;referrals\u0026rsquo; would provide the measure in which the indicators under \u0026lsquo;blood pressure level\u0026rsquo; and \u0026lsquo;treatment\u0026rsquo; dimensions were intended for. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMost of the indicators under the dimensions \u0026lsquo;monitoring\u0026rsquo; and \u0026lsquo;review of patients\u0026rsquo; were found appropriate and feasible. These indicators underpin the importance of recording activities and measurements that should be undertaken with the patient during the visit and provide the basis for quality of health care actions addressed in other dimensions. This is also important as it facilitates population level data collection with accurate data, which can then be used to inform future interventions needed to improve and sustain the quality of care at the PHC level in South Africa. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMost of the indicators under the dimension \u0026lsquo;tests\u0026rsquo; were also found appropriate and feasible. This is imperative as these indicators are about recording of the tests that were performed with patients. Consequently, providing a measure of whether the prescribed tests are conducted within the prescribed frequency amongst the hypertension patients at the PHC level in South Africa.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions and implications for patient care\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs mentioned, hypertension currently exerts a considerable health and economic burden on South Africa (13), with evidence that patients are currently not receiving the necessary evidence-based care in PHC facilities (5,12). \u0026nbsp;Moreover, the focus on monitoring patients with hypertension in South Africa is an imperative given the low levels of reported medication adherence (33), the fact that one‑third of patients often do not receive all their antihypertensive medicines from PHC facilities due to supply chain issues and generally poor access to quality care (7,12). Applying the care stated in these indicators would improve the outcomes, including their quality of life, amongst patients with confirmed diagnosis of hypertension being treated at the PHC level in South Africa.\u003c/p\u003e\n\u003cp\u003eThe indicators and framework for hypertension management from this study can be replicated for the management of type 2 diabetes mellitus and other NCDs in South Africa, which is a priority of the National Department of Health (3). Substandard quality of care contributes to the global disease burden and unmet health need in the population (3,17). This is especially important given the high prevalence of hypertension among people with diabetes in Africa and the urgent need for an integrated differentiated service delivery (22). Better monitoring and management of patients with hypertension will lead to improved quality of care, reduced avoidable harm, morbidity and mortality and will result in a more efficient use of scarce health care resources.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConsequently, our findings have implications not only for key stakeholder groups in South Africa to improve the care of patients with hypertension in the public system, but also across Africa. This study used the RAM which promotes robust, credible, and valid hypertension quality indicators as this methodology combines the available scientific evidence and expert opinion in the management of hypertension (28, 34). It is a practical, real-world method, designed to identify appropriate clinical steps tailored to patient needs and grounded in everyday practice of practitioners and facilities (23). Unlike other consensus techniques such as the Delphi Technique, the RAM incorporates interactive discussion of indicator statements between panellists in Round 2. In addition, a multidisciplinary panel of experts, all involved in the day-to-day management of people with hypertension, and from different provinces of South Africa, were used in the development of possible indicators. The mixed sample of panellists resulted in a wide variation of relevant views to hypertension management, including members of the South African hypertension guidelines, to enhance the possible utility of considered indicators. Two people chaired the panel meeting, a clinical and a methodologist expert, to add strength to the process and findings. \u0026nbsp;Online RAM panel meetings have been used successfully, in part in response to restrictions imposed by the COVID-19 pandemic, with online meetings at a reduced cost (34).\u003c/p\u003e\n\u003cp\u003eHypertension is the leading modifiable cardiovascular disease risk factor in South Africa and this study provides a possible solution to the current lack of quality measuring tools of healthcare provided to patients with hypertension at the PHC level, by identifying 46 evidence-based quality indicators specifically tailor-made to suit South African public PHC level settings. In addition, in view of the overlap in risk factors, prognosis, and treatment of hypertension and diabetes, agreed indicators also provide a platform to improve the monitoring of the management of patients with diabetes in PHCs based on the hypertension monitoring template. This approach can subsequently be used to develop quality indicators for all other high priority NCDs in South Africa and elsewhere in Africa. The use of the RAM has enabled researchers and practitioners to develop a preliminary but clearly outlined framework of indicators for the monitoring and management of people with hypertension receiving care from PHC in South Africa. Sound and reliable information is the foundation of decision-making in healthcare and appropriate next clinical steps for people with confirmed NCDs (18). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe WHO, World Bank Group and OECD have identified five foundational elements critical to delivering quality health care services as being health care workers; health care facilities; medicines, devices, and other technologies; information systems; and financing (17). It is imperative to develop and apply a tested hypertension management framework that is congruent to these foundational elements in South Africa as well as Africa as a whole, to enhance the potential utility of applying the indicators. \u0026nbsp;Outcomes from consensus techniques have face or content validity but the next step of the ongoing indicator development and testing protocol will be to test the 46 developed hypertension quality indicators for their data feasibility, reliability, and validity. In addition, to determine what implementation strategies might be needed in terms of workforce, facilities and medicines supply to apply the indicators at the PHC level in South Africa. Testing will also consider the clinimetric properties of the indicators to assess their value as measurement instruments as well as assess the appropriateness of hypertension management in the context of routine PHC/ambulatory care practice in South Africa, including the availability of routine data (35).\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eData Availability Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePlease note that additional data are available from the corresponding author on request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to appreciate all the panellists who contributed with their expertise during Round 1 and Round 2 of the RAND/UCLA Appropriateness Method process. \u0026nbsp;Sefako Makgatho Health Sciences University is thanked for granting ethical approval for this study and the South African National Research Foundation (NRF) (UID No. 129079)) for funding this study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEMR, JCM, SMC and BG conceptualised the study, wrote the protocol, and prepared for the RAND/UCLA Appropriateness Method panel meeting. SMC and NNN chaired the RAM panel meeting. EMR collected the data and EMR and SMC G conducted the data analysis. EMR drafted the manuscript and JCM, SMC and BG critically reviewed the manuscript, with EMR, JCM, SMC and BG involved in the subsequent revisions. All authors approved the final paper.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere are no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFinances\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe work presented in the paper was part of EMR\u0026rsquo;s PhD project, for which he received a postgraduate scholarship from the South African National Research Foundation (NRF) (Reference number: UID No. 129079).\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eRepublic of South Africa. 1996, Constitution of the Republic of South Africa. 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Euro Surveill. 2020; 25(27):1900468. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2807/1560-7917\u003c/span\u003e\u003cspan address=\"10.2807/1560-7917\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-human-hypertension","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"jhh","sideBox":"Learn more about [Journal of Human Hypertension](http://www.nature.com/jhh/)","snPcode":"41371","submissionUrl":"https://mts-jhh.nature.com/cgi-bin/main.plex","title":"Journal of Human Hypertension","twitterHandle":"@jhhypertension","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Hypertension, quality of care indicators, primary care, South Africa","lastPublishedDoi":"10.21203/rs.3.rs-4231707/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4231707/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eDespite many quality initiatives at the primary health care (PHC) level, little is known about the actual quality of care of patients diagnosed with hypertension in South Africa. The aim of this study was to develop quality indicators for hypertension management at the PHC level to improve the quality of care and patient outcomes. A 2-round RAND/UCLA Appropriateness Method was used to develop clear, appropriate, and feasible evidence-based quality indicators for hypertension. In round one, a 9-point scale was used by an 11-member panel to rate clarity and appropriateness of 102 hypertension quality indicator statements grouped under 9 dimensions of quality hypertension management, using an online MS Excel® spreadsheet. In round two, 9 of the same panellists discussed all indicators and rated their appropriateness and feasibility during a remote online, interactive face-to-face MS Teams® meeting. Statements rated ≥7-9 with agreement were defined as either appropriate or feasible. The panel rated 46 hypertension quality indicator statements ≥7-9 with agreement for the appropriate \u003cem\u003eand\u003c/em\u003efeasible measurement of the management of hypertension: monitoring (n=16), review (n=5), lifestyle advice (n=9), tests (n=7), intermediate outcomes (n=6), referrals (n=2) and practice/facility structures (n=1). No indicator statements were rated both appropriate and feasible for measuring blood pressure levels and treatment. If applied, these indicators would improve monitoring and management of patients with hypertension, patient outcomes, data quality and result in a more efficient use of scarce resources. This study can be replicable for improving care of other non-communicable diseases in South Africa and Africa.\u003c/p\u003e","manuscriptTitle":"Development of Quality Indicators for Hypertension Management at the Primary Health Care Level in South Africa","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-29 15:18:13","doi":"10.21203/rs.3.rs-4231707/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"revise","date":"2024-05-28T09:04:15+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"This content is not available.","date":"2024-05-24T13:42:41+00:00","index":2,"fulltext":"This content is not available."},{"type":"editorInvitedReview","content":"This content is not available.","date":"2024-05-10T18:14:14+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2024-05-01T21:09:02+00:00","index":2,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2024-04-27T16:21:57+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewersInvited","content":"","date":"2024-04-20T18:57:39+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-16T04:18:37+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-04-10T11:27:26+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Human Hypertension","date":"2024-04-09T17:03:06+00:00","index":"","fulltext":""},{"type":"checksFailed","content":"","date":"2024-04-08T10:39:05+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-human-hypertension","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"jhh","sideBox":"Learn more about [Journal of Human Hypertension](http://www.nature.com/jhh/)","snPcode":"41371","submissionUrl":"https://mts-jhh.nature.com/cgi-bin/main.plex","title":"Journal of Human Hypertension","twitterHandle":"@jhhypertension","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"b94abb4f-cb55-481d-8213-000761086ca0","owner":[],"postedDate":"April 29th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":31094337,"name":"Health sciences/Diseases"},{"id":31094338,"name":"Health sciences/Health care"}],"tags":[],"updatedAt":"2024-10-15T07:09:10+00:00","versionOfRecord":{"articleIdentity":"rs-4231707","link":"https://doi.org/10.1038/s41371-024-00966-7","journal":{"identity":"journal-of-human-hypertension","isVorOnly":false,"title":"Journal of Human Hypertension"},"publishedOn":"2024-10-14 04:00:00","publishedOnDateReadable":"October 14th, 2024"},"versionCreatedAt":"2024-04-29 15:18:13","video":"","vorDoi":"10.1038/s41371-024-00966-7","vorDoiUrl":"https://doi.org/10.1038/s41371-024-00966-7","workflowStages":[]},"version":"v1","identity":"rs-4231707","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4231707","identity":"rs-4231707","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}