Browsing by Author "Bateman, Eric"
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- ItemOpen AccessAddressing the quality and scope of paediatric primary care in South Africa: evaluating contextual impacts of the introduction of the Practical Approach to Care Kit for children (PACK Child)(2020-05-29) Murdoch, Jamie; Curran, Robyn; Cornick, Ruth; Picken, Sandy; Bachmann, Max; Bateman, Eric; Simelane, Makhosazana L; Fairall, LaraBackground Despite significant reductions in mortality, preventable and treatable conditions remain leading causes of death and illness in children in South Africa. The PACK Child intervention, comprising clinical decision support tool (guide), training strategy and health systems strengthening components, was developed to expand on WHO’s Integrated Management of Childhood Illness programme, extending care of children under 5 years to those aged 0–13 years, those with chronic conditions needing regular follow-up, integration of curative and preventive measures and routine care of the well child. In 2017–2018, PACK Child was piloted in 10 primary healthcare facilities in the Western Cape Province. Here we report findings from an investigation into the contextual features of South African primary care that shaped how clinicians delivered the PACK Child intervention within clinical consultations. Methods Process evaluation using linguistic ethnographic methodology which provides analytical tools for investigating human behaviour, and the shifting meaning of talk and text within context. Methods included semi-structured interviews, focus groups, ethnographic observation, audio-recorded consultations and documentary analysis. Analysis focused on how mapped contextual features structured clinician-caregiver interactions. Results Primary healthcare facilities demonstrated an institutionalised orientation to minimising risk upheld by provincial documentation, providing curative episodic care to children presenting with acute symptoms, and preventive care including immunisations, feeding and growth monitoring, all in children 5 years or younger. Children with chronic illnesses such as asthma rarely receive routine care. These contextual features constrained the ability of clinicians to use the PACK Child guide to facilitate diagnosis of long-term conditions, elicit and manage psychosocial issues, and navigate use of the guide alongside provincial documentation. Conclusion Our findings provide evidence that PACK Child is catalysing a transition to an approach that strikes a balance between assessing and minimising risk on the day of acute presentation and a larger remit of care for children over time. However, optimising success of the intervention requires reviewing priorities for paediatric care which will facilitate enhanced skills, knowledge and deployment of clinical staff to better address acute illnesses and long-term health conditions of children of all ages, as well as complex psychosocial issues surrounding the child.
- ItemOpen AccessAddressing the quality of paediatric primary care: health worker and caregiver perspectives from a process evaluation of PACK child, a health systems intervention in South Africa(2021-01-28) Curran, Robyn; Murdoch, Jamie; Bachmann, Max; Bateman, Eric; Cornick, Ruth; Picken, Sandra; Simelane, Makhosazana L; Fairall, LaraBackground The WHO’s Integrated Management of Childhood Illness (IMCI) has resulted in progress in addressing infant and child mortality. However, unmet needs of children continue to present a burden upon primary healthcare services. The capacity of services and quality of care offered require greater support to address these needs by extending and integrating curative and preventive care for the child with a long-term health condition and the child older than 5, not prioritised in IMCI. In response to these needs, the PACK Child intervention was developed and piloted in October 2017–February 2019 in the Western Cape Province of South Africa. We report health worker and caregiver perspectives of the existing paediatric primary care context as well as the extent to which PACK Child functions to address perceived problems within the current local healthcare system. Methods This process evaluation involved 52 individual interviews with caregivers, 10 focus group discussions with health workers, 3 individual interviews with trainers, and 31 training observations. Interviews and focus groups explored participants’ experiences of paediatric primary care, perspectives of the PACK Child intervention, and tensions with implementation in each context. Inductive thematic analysis was used to analyse verbatim interview and discussion transcripts. Results Perspectives of caregivers and health workers suggest an institutionalised focus of paediatric primary care to treating children’s symptoms as acute episodic conditions. Health workers’ reports imply that this focus is perpetuated by interactions between contextual features such as, IMCI policy, documentation-driven consultations, overcrowded clinics and verticalised care. Whilst these contextual conditions constrained health workers’ ability to translate skills developed within PACK Child training into practice, the intervention initiated expanded care of children 0–13 years and those with long-term health conditions, enhanced professional competence, improved teamwork and referrals, streamlined triaging, and facilitated probing for psychosocial risk. Conclusion PACK Child appears to be catalysing paediatric primary care to address the broader needs of children, including long-term health conditions and the identification of psychosocial problems. However, to maximise this requires primary care to re-orientate from risk minimisation on the day of attendance towards a view of the child beyond the day of presentation at clinics.
- ItemOpen AccessThe costs and effects of the practical approach to lung health in South Africa(2006) Fairall, Lara Rosemary; Bachmann, Max; Bateman, EricIncludes bibliographical references (p. 285-323).
- ItemOpen AccessDevelopment of a simple reliable radiographic scoring system to aid the diagnosis of pulmonary tuberculosis(Public Library of Science, 2013) Pinto, Lancelot M; Dheda, Keertan; Theron, Grant; Allwood, Brian; Calligaro, Gregory; van Zyl-Smit, Richard; Peter, Jonathan; Schwartzman, Kevin; Menzies, Dick; Bateman, Eric; Pai, Madhukar; Dawson, RodneyRationale: Chest radiography is sometimes the only method available for investigating patients with possible pulmonary tuberculosis (PTB) with negative sputum smears. However, interpretation of chest radiographs in this context lacks specificity for PTB, is subjective and is neither standardized nor reproducible. Efforts to improve the interpretation of chest radiography are warranted. Objectives To develop a scoring system to aid the diagnosis of PTB, using features recorded with the Chest Radiograph Reading and Recording System (CRRS). METHODS: Chest radiographs of outpatients with possible PTB, recruited over 3 years at clinics in South Africa were read by two independent readers using the CRRS method. Multivariate analysis was used to identify features significantly associated with culture-positive PTB. These were weighted and used to generate a score. RESULTS: 473 patients were included in the analysis. Large upper lobe opacities, cavities, unilateral pleural effusion and adenopathy were significantly associated with PTB, had high inter-reader reliability, and received 2, 2, 1 and 2 points, respectively in the final score. Using a cut-off of 2, scores below this threshold had a high negative predictive value (91.5%, 95%CI 87.1,94.7), but low positive predictive value (49.4%, 95%CI 42.9,55.9). Among the 382 TB suspects with negative sputum smears, 229 patients had scores <2; the score correctly ruled out active PTB in 214 of these patients (NPV 93.4%; 95%CI 89.4,96.3). The score had a suboptimal negative predictive value in HIV-infected patients (NPV 86.4, 95% CI 75,94). CONCLUSIONS: The proposed scoring system is simple, and reliably ruled out active PTB in smear-negative HIV-uninfected patients, thus potentially reducing the need for further tests in high burden settings. Validation studies are now required.
- ItemOpen AccessDiagnostic accuracy of an integrated respiratory guideline in identifying patients with respiratory symptoms requiring screening for pulmonary tuberculosis: a cross-sectional study(BioMed Central Ltd, 2006) English, Rene; Bachmann, Max; Bateman, Eric; Zwarenstein, Merrick; Fairall, Lara; Bheekie, Angeni; Majara, Bosielo; Lombard, Carl; Scherpbier, Robert; Ottomani, SalahBACKGROUND:To evaluate the diagnostic accuracy of the integrated Practical Approach to Lung Health in South Africa (PALSA) guideline in identifying patients requiring bacteriological screening for tuberculosis (TB), and to determine which clinical features best predict suspected and bacteriologically-confirmed tuberculosis among patients with respiratory symptoms. METHODS: A prospective, cross-sectional study in which 1392 adult patients with cough and/or difficult breathing, attending a primary care facility in Cape Town, South Africa, were evaluated by a nurse using the guideline. The accuracy of a nurse using the guideline to identify TB suspects was compared to that of primary care physicians' diagnoses of (1) suspected TB, and (2) proven TB supported by clinical information and chest radiographs. RESULTS: The nurse using the guideline identified 516 patients as TB suspects compared with 365 by the primary care physicians, representing a sensitivity of 76% (95% confidence interval (CI) 71%-79%), specificity of 77% (95% CI 74%-79%), positive predictive value of 53% (95% CI 49%-58%), negative predictive value of 90% (95% CI 88%-92%), and area under the receiver operating characteristic curve (ARUC) of 0.76 (95% CI 0.74-0.79). Sputum results were obtained in 320 of the 365 primary care physicians TB suspects (88%); 40 (13%) of these were positive for TB. Only 4 cases were not identified by the nurse using the guideline. The primary care physicians diagnostic accuracy in diagnosing bacteriologically-confirmed TB (n = 320) was as follows: sensitivity 90% (95% CI 76%-97%), specificity 65% (95% CI 63%-68%), negative predictive value 7% (95% CI 5%-10%), positive predictive value 99.5% (95% CI 98.8%-99.8%), and ARUC 0.78 (95% CI 0.73-0.82). Weight loss, pleuritic pain, and night sweats were independently associated with the diagnosis of bacteriologically-confirmed tuberculosis (positive likelihood ratio if all three present = 16.7, 95% CI 5.9-29.4). CONCLUSION: The PALSA guideline is an effective screening tool for identifying patients requiring bacteriological screening for pulmonary tuberculosis in this primary care setting. This supports the randomized trial finding that use of the guideline increased TB case detection.
- ItemOpen AccessEfficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease(BioMed Central Ltd, 2011) Jones, Paul; Rennard, Stephen; Agusti, Alvar; Chanez, Pascal; Magnussen, Helgo; Fabbri, Leonardo; Donohue, James; Bateman, Eric; Gross, Nicholas; Lamarca, Rosa; Caracta, Cynthia; Gil, EstherBACKGROUND: The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD). METHODS: In two double-blind, 52-week studies, ACCLAIM/COPD I (n = 843) and II (n = 804), patients were randomised to inhaled aclidinium 200 mug or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of [less than or equal to]70% and FEV1 <80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation. RESULTS: At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p < 0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p < 0.001). More patients had a SGRQ improvement [greater than or equal to]4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p = 0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p = 0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p = 0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p = 0.9). Adverse events were minor in both studies. CONCLUSION: Aclidinium is effective and well tolerated in patients with moderate to severe COPD.TRIAL REGISTRATION:ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II).
- ItemOpen AccessEvaluating a streamlined clinical tool and educational outreach intervention for health care workers in Malawi: the PALM PLUS case study(BioMed Central Ltd, 2011) Sodhi, Sumeet; Banda, Hastings; Kathyola, Damson; Burciul, Barry; Thompson, Sandy; Joshua, Martias; Bateman, Eric; Fairall, Lara; Martiniuk, Alexandra; Cornick, Ruth; Faris, Gill; Draper, Beverley; Mondiwa, Martha; Katengeza, Egnat; Sanudi, Lifah; ZwBACKGROUND: Nearly 3 million people in resource-poor countries receive antiretrovirals for the treatment of HIV/AIDS, yet millions more require treatment. Key barriers to treatment scale up are shortages of trained health care workers, and challenges integrating HIV/AIDS care with primary care.THE RESEARCH:PALM PLUS (Practical Approach to Lung Health and HIV/AIDS in Malawi) is an intervention designed to simplify and integrate existing Malawian national guidelines into a single, simple, user-friendly guideline for mid-level health care workers. Training utilizes a peer-to-peer educational outreach approach. Research is being undertaken to evaluate this intervention to generate evidence that will guide future decision-making for consideration of roll out in Malawi. The research consists of a cluster randomized trial in 30 public health centres in Zomba District that measures the effect of the intervention on staff satisfaction and retention, quality of patient care, and costs through quantitative, qualitative and health economics methods.RESULTS AND OUTCOMES:In the first phase of qualitative inquiry respondents from intervention sites demonstrated in-depth knowledge of PALM PLUS compared to those from control sites. Participants in intervention sites felt that the PALM PLUS tool empowered them to provide better health services to patients. Interim staff retention data shows that there were, on average, 3 to 4 staff departing from the control and intervention sites per month. Additional qualitative, quantitative and economic analyses are planned.THE PARTNERSHIP:Dignitas International and the Knowledge Translation Unit at the University of Cape Town Lung Institute have led the adaptation and development of the PALM PLUS intervention, using experience gained through the implementation of the South African precursor, PALSA PLUS. The Malawian partners, REACH Trust and the Research Unit at the Ministry of Health, have led the qualitative and economic evaluations. Dignitas and Ministry of Health have facilitated interaction with implementers and policy-makers.CHALLENGES AND SUCCESSES:This initiative is an example of South-South knowledge translation between South Africa and Malawi, mediated by a Canadian academic-NGO hybrid. Our success in developing and rolling out PALM PLUS in Malawi suggests that it is possible to adapt and implement this intervention for use in other resource-limited settings.
- ItemOpen AccessFrom PALSA PLUS to PALM PLUS: adapting and developing a South African guideline and training intervention to better integrate HIV/AIDS care with primary care in rural health centers in Malawi(BioMed Central Ltd, 2011) Schull, Michael; Cornick, Ruth; Thompson, Sandy; Faris, Gill; Fairall, Lara; Burciul, Barry; Sodhi, Sumeet; Draper, Beverley; Joshua, Martias; Mondiwa, Martha; Banda, Hastings; Kathyola, Damson; Bateman, Eric; Zwarenstein, MerrickBACKGROUND: Only about one-third of eligible HIV/AIDS patients receive anti-retroviral treatment (ART). Decentralizing treatment is crucial to wider and more equitable access, but key obstacles are a shortage of trained healthcare workers (HCW) and challenges integrating HIV/AIDS care with other primary care. This report describes the development of a guideline and training program (PALM PLUS) designed to integrate HIV/AIDS care with other primary care in Malawi. PALM PLUS was adapted from PALSA PLUS, developed in South Africa, and targets middle-cadre HCWs (clinical officers, nurses, and medical assistants). We adapted it to align with Malawi's national treatment protocols, more varied healthcare workforce, and weaker health system infrastructure.METHODS/DESIGN:The international research team included the developers of the PALSA PLUS program, key Malawi-based team members and personnel from national and district level Ministry of Health (MoH), professional associations, and an international non-governmental organization. The PALSA PLUS guideline was extensively revised based on Malawi national disease-specific guidelines. Advice and input was sought from local clinical experts, including middle-cadre personnel, as well as Malawi MoH personnel and representatives of Malawian professional associations. RESULTS: An integrated guideline adapted to Malawian protocols for adults with respiratory conditions, HIV/AIDS, tuberculosis, and other primary care conditions was developed. The training program was adapted to Malawi's health system and district-level supervision structure. PALM PLUS is currently being piloted in a cluster-randomized trial in health centers in Malawi (ISRCTN47805230).DISCUSSION:The PALM PLUS guideline and training intervention targets primary care middle-cadre HCWs with the objective of improving HCW satisfaction and retention, and the quality of patient care. Successful adaptations are feasible, even across health systems as different as those of South Africa and Malawi.
- ItemOpen AccessGlobal asthma prevalence in adults: findings from the cross-sectional world health survey(BioMed Central Ltd, 2012) To, Teresa; Stanojevic, Sanja; Moores, Ginette; Gershon, Andrea; Bateman, Eric; Cruz, Alvaro; Boulet, Louis-PhilippeBACKGROUND: Asthma is a major cause of disability, health resource utilization and poor quality of life world-wide. We set out to generate estimates of the global burden of asthma in adults, which may inform the development of strategies to address this common disease. METHODS: The World Health Survey (WHS) was developed and implemented by the World Health Organization in 2002-2003. A total of 178,215 individuals from 70 countries aged 18 to 45 years responded to questions related to asthma and related symptoms. The prevalence of asthma was based on responses to questions relating to self-reported doctor diagnosed asthma, clinical/treated asthma, and wheezing in the last 12 months. RESULTS: The global prevalence rates of doctor diagnosed asthma, clinical/treated asthma and wheezing in adults were 4.3%, 4.5%, and 8.6% respectively, and varied by as much as 21-fold amongst the 70 countries. Australia reported the highest rate of doctor diagnosed, clinical/treated asthma, and wheezing (21.0%, 21.5%, and 27.4%). Amongst those with clinical/treated asthma, almost 24% were current smokers, half reported wheezing, and 20% had never been treated for asthma. CONCLUSIONS: This study provides a global estimate of the burden of asthma in adults, and suggests that asthma continues to be a major public health concern worldwide. The high prevalence of smoking remains a major barrier to combating the global burden of asthma. While the highest prevalence rates were observed in resource-rich countries, resource-poor nations were also significantly affected, posing a barrier to development as it stretches further the demands of non-communicable diseases.
- ItemOpen AccessImmunomodulation with recombinant interferon-γ1b in pulmonary tuberculosis(Public Library of Science, 2009) Dawson, Rod; Condos, Rany; Tse, Doris; Huie, Maryann L; Ress, Stanley; Tseng, Chi-Hong; Brauns, Clint; Weiden, Michael; Hoshino, Yoshihiko; Bateman, EricBACKGROUND: Current treatment regimens for pulmonary tuberculosis require at least 6 months of therapy. Immune adjuvant therapy with recombinant interferon-γ1b (rIFN-γb) may reduce pulmonary inflammation and reduce the period of infectivity by promoting earlier sputum clearance. METHODOLOGY/PRINCIPAL FINDINGS: We performed a randomized, controlled clinical trial of directly observed therapy (DOTS) versus DOTS supplemented with nebulized or subcutaneously administered rIFN-γ1b over 4 months to 89 patients with cavitary pulmonary tuberculosis. Bronchoalveolar lavage (BAL) and blood were sampled at 0 and 4 months. There was a significant decline in levels of inflammatory cytokines IL-1β, IL-6, IL-8, and IL-10 in 24-hour BAL supernatants only in the nebulized rIFN-γ1b group from baseline to week 16. Both rIFN-γ1b groups showed significant 3-fold increases in CD4+ lymphocyte response to PPD at 4 weeks. There was a significant (p = 0.03) difference in the rate of clearance of Mtb from the sputum smear at 4 weeks for the nebulized rIFN-γ1b adjuvant group compared to DOTS or DOTS with subcutaneous rIFN-γ1b. In addition, there was significant reduction in the prevalence of fever, wheeze, and night sweats at 4 weeks among patients receiving rFN-γ1b versus DOTS alone. CONCLUSION: Recombinant interferon-γ1b adjuvant therapy plus DOTS in cavitary pulmonary tuberculosis can reduce inflammatory cytokines at the site of disease, improve clearance of Mtb from the sputum, and improve constitutional symptoms. Trial Registration ClinicalTrials.gov NCT00201123
- ItemOpen AccessImplementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial(BioMed Central Ltd, 2012) Georgeu, Daniella; Colvin, Christopher; Lewin, Simon; Fairall, Lara; Bachmann, Max; Uebel, Kerry; Zwarenstein, Merrick; Draper, Beverly; Bateman, EricBACKGROUND:Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme. METHODS: This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis. RESULTS: NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health staff, demands significant training and support, and faces workload and capacity constraints, and logistical and infrastructural challenges. CONCLUSIONS: Large-scale NIMART appears to be feasible and acceptable in the primary level public sector health services in South Africa. Successful implementation requires a comprehensive approach with: an incremental and well supported approach to implementation; clinical guidelines tailored to nurses; and significant health services reorganisation to accommodate the knock-on effects of shifts in practice.TRIAL REGISTRATION:ISRCTN46836853
- ItemOpen AccessIncreased production of IL-4 and IL-12p40 from bronchoalveolar lavage cells are biomarkers of Mycobacterium tuberculosis in the sputum(Public Library of Science, 2013) Nolan, Anna; Fajardo, Elaine; Huie, Maryann L; Condos, Rany; Pooran, Anil; Dawson, Rodney; Dheda, Keertan; Bateman, Eric; Rom, William N; Weiden, Michael DBACKGROUND: Tuberculosis (TB) causes 1.45 million deaths annually world wide, the majority of which occur in the developing world. Active TB disease represents immune failure to control latent infection from airborne spread. Acid-fast bacillus (AFB) seen on sputum smear is a biomarker for contagiousness. METHODS: We enrolled 73 tuberculosis patients with extensive infiltrates into a research study using bronchoalveolar lavage (BAL) to sample lung immune cells and assay BAL cell cytokine production. All patients had sputum culture demonstrating Mycobacterium tuberculosis and 59/73 (81%) had AFB identified by microscopy of the sputum. Compared with smear negative patients, smear positive patients at presentation had a higher proportion with smoking history, a higher proportion with temperature >38.5 0 C, higher BAL cells/ml, lower percent lymphocytes in BAL, higher IL-4 and IL-12p40 in BAL cell supernatants. There was no correlation between AFB smear and other BAL or serum cytokines. Increasing IL-4 was associated with BAL PMN and negatively associated with BAL lymphocytes. Each 10-fold increase in BAL IL-4 and IL-12p40 increased the odds of AFB smear positivity by 7.4 and 2.2-fold, respectively, in a multi-variable logistic model. CONCLUSION: Increasing IL-4 and IL-12p40 production by BAL cells are biomarkers for AFB in sputum of patients who present with radiographically advanced TB. They likely reflect less effective immune control of pathways for controlling TB, leading to patients with increased infectiousness.
- ItemOpen AccessNext-generation ARIA care pathways for rhinitis and asthma: a model for multimorbid chronic diseases(2019-09-09) Bousquet, J. J; Schünemann, Holger J; Togias, Alkis; Erhola, Marina; Hellings, Peter W; Zuberbier, Torsten; Agache, Ioana; Ansotegui, Ignacio J; Anto, Josep M; Bachert, Claus; Becker, Sven; Bedolla-Barajas, Martin; Bewick, Michael; Bosnic-Anticevich, Sinthia; Bosse, Isabelle; Boulet, Louis P; Bourrez, Jean M; Brusselle, Guy; Chavannes, Niels; Costa, Elisio; Cruz, Alvaro A; Czarlewski, Wienczyslawa; Fokkens, Wytske J; Fonseca, Joao A; Gaga, Mina; Haahtela, Tari; Illario, Maddalena; Klimek, Ludger; Kuna, Piotr; Kvedariene, Violeta; Le, L. T T; Larenas-Linnemann, Desiree; Laune, Daniel; Lourenço, Olga M; Menditto, Enrica; Mullol, Joaquin; Okamoto, Yashitaka; Papadopoulos, Nikos; Pham-Thi, Nhân; Picard, Robert; Pinnock, Hilary; Roche, Nicolas; Roller-Wirnsberger, Regina E; Rolland, Christine; Samolinski, Boleslaw; Sheikh, Aziz; Toppila-Salmi, Sanna; Tsiligianni, Ioanna; Valiulis, Arunas; Valovirta, Erkka; Vasankari, Tuula; Ventura, Maria-Teresa; Walker, Samantha; Williams, Sian; Akdis, Cezmi A; Annesi-Maesano, Isabella; Arnavielhe, Sylvie; Basagana, Xavier; Bateman, Eric; Bedbrook, Anna; Bennoor, K. S; Benveniste, Samuel; Bergmann, Karl C; Bialek, Slawomir; Billo, Nils; Bindslev-Jensen, Carsten; Bjermer, Leif; Blain, Hubert; Bonini, Mateo; Bonniaud, Philippe; Bouchard, Jacques; Briedis, Vitalis; Brightling, Christofer E; Brozek, Jan; Buhl, Roland; Buonaiuto, Roland; Canonica, Giorgo W; Cardona, Victoria; Carriazo, Ana M; Carr, Warner; Cartier, Christine; Casale, Thomas; Cecchi, Lorenzo; Cepeda Sarabia, Alfonso M; Chkhartishvili, Eka; Chu, Derek K; Cingi, Cemal; Colgan, Elaine; de Sousa, Jaime C; Courbis, Anne L; Custovic, Adnan; Cvetkosvki, Biljana; D’Amato, Gennaro; da Silva, Jane; Dantas, Carina; Dokic, Dejand; Dauvilliers, Yves; Dedeu, Antoni; De Feo, Giulia; Devillier, Philippe; Di Capua, Stefania; Dykewickz, Marc; Dubakiene, Ruta; Ebisawa, Motohiro; El-Gamal, Yaya; Eller, Esben; Emuzyte, Regina; Farrell, John; Fink-Wagner, Antjie; Fiocchi, Alessandro; Fontaine, Jean F; Gemicioğlu, Bilun; Schmid-Grendelmeir, Peter; Gamkrelidze, Amiran; Garcia-Aymerich, Judith; Gomez, Maximiliano; González Diaz, Sandra; Gotua, Maia; Guldemond, Nick A; Guzmán, Maria-Antonieta; Hajjam, Jawad; O’B Hourihane, John; Humbert, Marc; Iaccarino, Guido; Ierodiakonou, Despo; Illario, Maddalena; Ivancevich, Juan C; Joos, Guy; Jung, Ki-Suck; Jutel, Marek; Kaidashev, Igor; Kalayci, Omer; Kardas, Przemyslaw; Keil, Thomas; Khaitov, Mussa; Khaltaev, Nikolai; Kleine-Tebbe, Jorg; Kowalski, Marek L; Kritikos, Vicky; Kull, Inger; Leonardini, Lisa; Lieberman, Philip; Lipworth, Brian; Lodrup Carlsen, Karin C; Loureiro, Claudia C; Louis, Renaud; Mair, Alpana; Marien, Gert; Mahboub, Bassam; Malva, Joao; Manning, Patrick; De Manuel Keenoy, Esteban; Marshall, Gailen D; Masjedi, Mohamed R; Maspero, Jorge F; Mathieu-Dupas, Eve; Matricardi, Poalo M; Melén, Eric; Melo-Gomes, Elisabete; Meltzer, Eli O; Menditto, Enrica; Mercier, Jacques; Miculinic, Neven; Mihaltan, Florin; Milenkovic, Branislava; Moda, Giuliana; Mogica-Martinez, Maria-Dolores; Mohammad, Yousser; Montefort, Steve; Monti, Ricardo; Morais-Almeida, Mario; Mösges, Ralf; Münter, Lars; Muraro, Antonella; Murray, Ruth; Naclerio, Robert; Napoli, Luigi; Namazova-Baranova, Leila; Neffen, Hugo; Nekam, Kristoff; Neou, Angelo; Novellino, Enrico; Nyembue, Dieudonné; O’Hehir, Robin; Ohta, Ken; Okubo, Kimi; Onorato, Gabrielle; Ouedraogo, Solange; Pali-Schöll, Isabella; Palkonen, Susanna; Panzner, Peter; Park, Hae-Sim; Pépin, Jean-Louis; Pereira, Ana-Maria; Pfaar, Oliver; Paulino, Ema; Phillips, Jim; Picard, Robert; Plavec, Davor; Popov, Ted A; Portejoie, Fabienne; Price, David; Prokopakis, Emmanuel P; Pugin, Benoit; Raciborski, Filip; Rajabian-Söderlund, Rojin; Reitsma, Sietze; Rodo, Xavier; Romano, Antonino; Rosario, Nelson; Rottem, Menahenm; Ryan, Dermot; Salimäki, Johanna; Sanchez-Borges, Mario M; Sisul, Juan-Carlos; Solé, Dirceu; Somekh, David; Sooronbaev, Talant; Sova, Milan; Spranger, Otto; Stellato, Cristina; Stelmach, Rafael; Suppli Ulrik, Charlotte; Thibaudon, Michel; To, Teresa; Todo-Bom, Ana; Tomazic, Peter V; Valero, Antonio A; Valenta, Rudolph; Valentin-Rostan, Marylin; van der Kleij, Rianne; Vandenplas, Olivier; Vezzani, Giorgio; Viart, Frédéric; Viegi, Giovanni; Wallace, Dana; Wagenmann, Martin; Wang, De Y; Waserman, Susan; Wickman, Magnus; Williams, Dennis M; Wong, Gary; Wroczynski, Piotr; Yiallouros, Panayiotis K; Yorgancioglu, Arzu; Yusuf, Osman M; Zar, Heahter J; Zeng, Stéphane; Zernotti, Mario; Zhang, Luo; Zhong, Nan S; Zidarn, MihaelaAbstract Background In all societies, the burden and cost of allergic and chronic respiratory diseases are increasing rapidly. Most economies are struggling to deliver modern health care effectively. There is a need to support the transformation of the health care system into integrated care with organizational health literacy. Main body As an example for chronic disease care, MASK (Mobile Airways Sentinel NetworK), a new project of the ARIA (Allergic Rhinitis and its Impact on Asthma) initiative, and POLLAR (Impact of Air POLLution on Asthma and Rhinitis, EIT Health), in collaboration with professional and patient organizations in the field of allergy and airway diseases, are proposing real-life ICPs centred around the patient with rhinitis, and using mHealth to monitor environmental exposure. Three aspects of care pathways are being developed: (i) Patient participation, health literacy and self-care through technology-assisted “patient activation”, (ii) Implementation of care pathways by pharmacists and (iii) Next-generation guidelines assessing the recommendations of GRADE guidelines in rhinitis and asthma using real-world evidence (RWE) obtained through mobile technology. The EU and global political agendas are of great importance in supporting the digital transformation of health and care, and MASK has been recognized by DG Santé as a Good Practice in the field of digitally-enabled, integrated, person-centred care. Conclusion In 20 years, ARIA has considerably evolved from the first multimorbidity guideline in respiratory diseases to the digital transformation of health and care with a strong political involvement.
- ItemOpen AccessOverall asthma control achieved with budesonide/formoterol maintenance and reliever therapy for patients on different treatment steps(BioMed Central Ltd, 2011) Bateman, Eric; Harrison, Tim; Quirce, Santiago; Reddel, Helen; Buhl, Roland; Humbert, Marc; Jenkins, Christine; Peterson, Stefan; Ostlund, Ollie; O'Byrne, Paul; Sears, Malcolm; Eriksson, GoranBACKGROUND: Adjusting medication for uncontrolled asthma involves selecting one of several options from the same or a higher treatment step outlined in asthma guidelines. We examined the relative benefit of introducing budesonide/formoterol (BUD/FORM) maintenance and reliever therapy (Symbicort SMART(R) Turbuhaler(R)) in patients previously prescribed treatments from Global Initiative for Asthma (GINA) Steps 2, 3 or 4. METHODS: This is a post hoc analysis of the results of five large clinical trials (>12000 patients) comparing BUD/FORM maintenance and reliever therapy with other treatments categorised by treatment step at study entry. Both current clinical asthma control during the last week of treatment and exacerbations during the study were examined. RESULTS: At each GINA treatment step, the proportion of patients achieving target levels of current clinical control were similar or higher with BUD/FORM maintenance and reliever therapy compared with the same or a higher fixed maintenance dose of inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) (plus short-acting beta2-agonist [SABA] as reliever), and rates of exacerbations were lower at all treatment steps in BUD/FORM maintenance and reliever therapy versus same maintenance dose ICS/LABA (P < 0.01) and at treatment Step 4 versus higher maintenance dose ICS/LABA (P < 0.001). BUD/FORM maintenance and reliever therapy also achieved significantly higher rates of current clinical control and significantly lower exacerbation rates at most treatment steps compared with a higher maintenance dose ICS + SABA (Steps 2-4 for control and Steps 3 and 4 for exacerbations). With all treatments, the proportion of patients achieving current clinical control was lower with increasing treatment steps. CONCLUSIONS: BUD/FORM maintenance and reliever therapy may be a preferable option for patients on Steps 2 to 4 of asthma guidelines requiring a more effective treatment and, compared with other fixed dose alternatives, is most effective in the higher treatment steps.
- ItemOpen AccessStreamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol(BioMed Central Ltd, 2008) Fairall, Lara; Bachmann, Max; Zwarenstein, Merrick; Lombard, Carl; Uebel, Kerry; van Vuuren, Cloete; Steyn, Dewald; Boulle, Andrew; Bateman, EricBACKGROUND: A major barrier to accessing free government-provided antiretroviral treatment (ART) in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults.METHODS/DESIGN:This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART) for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a) 7400 registering with the programme with CD4 counts of [less than or equal to] 350 cells/mL (mainly to evaluate treatment initiation) and b) 4900 already receiving ART (to evaluate ongoing treatment and monitoring). The primary outcomes will be time to death (in the first group) and viral suppression (in the second group). Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register.TRIAL REGISTRATION:Controlled Clinical Trials ISRCTN46836853
- ItemOpen AccessStrengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial(BioMed Central Ltd, 2010) Schull, Michael; Banda, Hastings; Kathyola, Damson; Fairall, Lara; Martiniuk, Alexandra; Burciul, Barry; Zwarenstein, Merrick; Sodhi, Sumeet; Thompson, Sandy; Joshua, Martias; Mondiwa, Martha; Bateman, EricBACKGROUND:In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care.METHODS/DESIGN:A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation.DISCUSSION:The PALM PLUS trial aims to address a key problem: strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care. The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention, as well as the quality of patient care, when compared to usual practice.TRIAL REGISTRATION:Current controlled Trials: ISRCTN47805230
- ItemOpen AccessSupporting middle-cadre health care workers in Malawi: lessons learned during implementation of the PALM PLUS package(BioMed Central, 2014-05-12) Sodhi, Sumeet; Banda, Hastings; Kathyola, Damson; Joshua, Martias; Richardson, Faye; Mah, Emmay; MacGregor, Hayley; Kanike, Emmanuel; Thompson, Sandy; Fairall, Lara; Bateman, Eric; Zwarenstein, Merrick; Schull, Michael JBackground: The government of Malawi is committed to the broad rollout of antiretroviral treatment in Malawi in the public health sector; however one of the primary challenges has been the shortage of trained health care workers. The Practical Approach to Lung Health Plus HIV/AIDS in Malawi (PALM PLUS) package is an innovative guideline and training intervention that supports primary care middle-cadre health care workers to provide front-line integrated primary care. The purpose of this paper is to describe the lessons learned in implementing the PALM PLUS package. Methods: A clinical tool, based on algorithm- and symptom-based guidelines was adapted to the Malawian context. An accompanying training program based on educational outreach principles was developed and a cascade training approach was used for implementation of the PALM PLUS package in 30 health centres, targeting clinical officers, medical assistants, and nurses. Lessons learned were identified during program implementation through engagement with collaborating partners and program participants and review of program evaluation findings. Results: Key lessons learned for successful program implementation of the PALM PLUS package include the importance of building networks for peer-based support, ensuring adequate training capacity, making linkages with continuing professional development accreditation and providing modest in-service training budgets. The main limiting factors to implementation were turnover of staff and desire for financial training allowances. Conclusions: The PALM PLUS approach is a potential model for supporting mid-level health care workers to provide front-line integrated primary care in low and middle income countries, and may be useful for future task-shifting initiatives.
- ItemOpen AccessTask shifting and integration of HIV care into primary care in South Africa: The development and content of the streamlining tasks and roles to expand treatment and care for HIV (STRETCH) intervention(BioMed Central Ltd, 2011) Uebel, Kerry; Fairall, Lara; van Rensburg, Dingie; Mollentze, Willie; Bachmann, Max; Lewin, Simon; Zwarenstein, Merrick; Colvin, Christopher; Georgeu, Daniella; Mayers, Pat; Faris, Gill; Lombard, Carl; Bateman, EricBACKGROUND:Task shifting and the integration of human immunodeficiency virus (HIV) care into primary care services have been identified as possible strategies for improving access to antiretroviral treatment (ART). This paper describes the development and content of an intervention involving these two strategies, as part of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) pragmatic randomised controlled trial. METHODS: DEVELOPING THE INTERVENTION:The intervention was developed following discussions with senior management, clinicians, and clinic staff. These discussions revealed that the establishment of separate antiretroviral treatment services for HIV had resulted in problems in accessing care due to the large number of patients at ART clinics. The intervention developed therefore combined the shifting from doctors to nurses of prescriptions of antiretrovirals (ARVs) for uncomplicated patients and the stepwise integration of HIV care into primary care services. RESULTS: COMPONENTS OF THE INTERVENTION:The intervention consisted of regulatory changes, training, and guidelines to support nurse ART prescription, local management teams, an implementation toolkit, and a flexible, phased introduction. Nurse supervisors were equipped to train intervention clinic nurses in ART prescription using outreach education and an integrated primary care guideline. Management teams were set up and a STRETCH coordinator was appointed to oversee the implementation process.DISCUSSION:Three important processes were used in developing and implementing this intervention: active participation of clinic staff and local and provincial management, educational outreach to train nurses in intervention sites, and an external facilitator to support all stages of the intervention rollout.The STRETCH trial is registered with Current Control Trials ISRCTN46836853.
- ItemOpen AccessThe SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given ‘as needed’ in mild asthma: study protocols for two randomised controlled trials(BioMed Central, 2017-01-10) O’Byrne, Paul M; FitzGerald, J Mark; Zhong, Nanshan; Bateman, Eric; Barnes, Peter J; Keen, Christina; Almqvist, Gun; Pemberton, Kristine; Jorup, Carin; Ivanov, Stefan; Reddel, Helen KBackground: In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poor control of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol ‘as needed’ in response to symptoms may represent an alternative treatment option for patients with mild asthma. Methods/design: The SYmbicort Given as needed in Mild Asthma (SYGMA) programme consists of two 52-week, double-blind, randomised, multicentre, parallel-group, phase 3 trials of patients aged 12 years and older with a clinical diagnosis of asthma for at least 6 months, who would qualify for treatment with regular inhaled corticosteroids (ICS). SYGMA1 aims to recruit 3750 patients who will be randomised to placebo twice daily (bid) plus as-needed budesonide/formoterol 160/4.5 μg, placebo bid plus as-needed terbutaline 0.4 mg, or budesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the superiority of as-needed budesonide/formoterol over as-needed terbutaline for asthma control, as measured by well-controlled asthma weeks; a secondary objective is to establish the noninferiority of as-needed budesonide/formoterol versus maintenance budesonide plus as-needed terbutaline using the same outcome measure. SYGMA2 aims to recruit 4114 patients who will be randomised to placebo bid plus as-needed budesonide/formoterol 160/4.5 μg, or budesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the noninferiority of as-needed budesonide/formoterol over budesonide bid plus as-needed terbutaline as measured by the annualised severe exacerbation rate. In both studies, use of all blinded study inhalers will be recorded electronically using Turbuhaler® Usage Monitors. Discussion: Given the known risks of mild asthma, and known poor adherence with regular inhaled corticosteroids, the results of the SYGMA programme will help to determine the efficacy and safety of as-needed budesonide/ formoterol therapy in mild asthma. Patient recruitment is complete, and completion of the phase 3 studies is planned in 2017. Trial registration: ClinicalTrials.gov identifiers: NCT02149199 SYGMA1 and NCT02224157 SYGMA2. Registered on 16 May 2014 and 19 August 2014, respectively.