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Effects of PACK guide training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians: a pragmatic cluster randomised controlled trial in Florianópolis, Brazil
  1. Max Oscar Bachmann1,
  2. Eric D Bateman2,
  3. Rafael Stelmach3,
  4. Alvaro A Cruz4,
  5. Matheus Pacheco de Andrade5,
  6. Ronaldo Zonta5,
  7. Jorge Zepeda6,
  8. Sonia Natal7,
  9. Ruth Vania Cornick2,
  10. Camilla Wattrus2,
  11. Lauren Anderson2,
  12. Daniella Georgeu-Pepper2,
  13. Carl Lombard8,
  14. Lara R Fairall2
  1. 1Norwich Medical School, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, UK
  2. 2Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, Western Cape, South Africa
  3. 3University of Sao Paulo, Sao Paulo, Brazil
  4. 4ProAR, Universidade Federal da Bahia, Salvador, Bahia, Brazil
  5. 5Gerência de Integração Assistencial, Secretaria Municipal de Saúde, Florianópolis, Santa Catarina, Brazil
  6. 6LIHS, University of Leeds, Leeds, UK
  7. 7Public Health, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, Brazil
  8. 8Biostatistics Unit, Medical Research Council, Cape Town, South Africa
  1. Correspondence to Professor Max Oscar Bachmann; M.Bachmann{at}


Introduction The Practical Approach to Care Kit (PACK) guide was localised for Brazil, where primary care doctors and nurses were trained to use it.

Methods Twenty-four municipal clinics in Florianópolis were randomly allocated to receive outreach training and the guide, and 24 were allocated to receive only the guide. 6666 adult patients with asthma or chronic obstructive pulmonary disease (COPD) were enrolled, and trial outcomes were measured over 12 months, using electronic medical records. The primary outcomes were composite scores of treatment changes and spirometry, and new asthma and COPD diagnosis rates.

Results Asthma scores in 2437 intervention group participants were higher (74.8%, 20.4% and 4.8% with scores of 0, 1 and 2, respectively) than in 2633 control group participants (80.0%, 16.8% and 3.2%) (OR for higher score 1.32, 95% CI 1.08 to 1.61, p=0.006). Adjusted for asthma scores recorded in each clinic before training started, the OR was 1.24 (95% CI 1.03 to 1.50, p=0.022). COPD scores in 1371 intervention group participants (77.7%, 17.9% and 4.3% with scores of 0, 1 and 2) did not differ from those in 1181 control group participants (80.5%, 15.8% and 3.7%) (OR 1.21, 95% CI 0.94 to 1.55, p=0.142). Rates of new asthma and COPD diagnoses, and hospital admission, and indicators of investigation, diagnosis and treatment of comorbid cardiovascular disease, diabetes and depression, and tobacco cessation did not differ between trial arms.

Conclusion PACK training increased guideline-based treatment and spirometry for asthma but did not affect COPD or comorbid conditions, or diagnosis rates.

  • primary care
  • respiratory disease
  • educational outreach
  • implementation research

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  • Handling editor Seye Abimbola

  • Twitter @sonianatal

  • Contributors MOB, EDB, RS, AAC, MPdA, RZ, JZ, SN, CL and LRF conceived of and designed the study. EDB, MPdA, RZ, JZ, SN, RVC, CW, LA, DG-P and LRF contributed to development of the PACK Brasil Adulto—versão Florianópolis guide and training materials. MPdA collated the electronic medical record data and MOB carried out the statistical analysis. All authors contributed to writing the paper and approved the final manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests We have read and understood BMJ policy on declaration of interests and declare that CW, LRF, DG-P, LA, RVC and EDB are employees of the KTU. RZ and MPdA are employees of the City Health Department, Florianópolis, Brazil. JZ is an ex-employee of the City Health Department, Florianópolis, Brazil and a current holder of full-time PhD studentship from the Brazilian research agency CNPq. AAC reports grants, personal fees and non-financial support from GSK, personal fees and non-financial support from AstraZeneca, personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from MEDA, personal fees and non-financial support from Novartis, personal fees and non-financial support from EUROFARMA, personal fees and non-financial support from CHIESI, personal fees and non-financial support from Boston Scientific, outside the submitted work. EDB reports grants to institution for clinical trials from Novartis, Boehringer Ingelheim, Merck, Takeda, GlaxoSmithKline, Hoffmann La Roche, Actelion, Chiesi, Sanofi-Aventis, Cephalon, TEVA and AstraZeneca and personal fees from ICON, Novartis, Cipla, Vectura, Cipla, Menarini, ALK, ICON, Sanofi Regeneron, Boehringer Ingelheim and AstraZeneca, outside the submitted work, and is a Member of Global Initiative for Asthma Board and Science Committee. RS reports grants for clinical trials, personal, institution fees and non-financial support from AstraZeneca, and personal fees and non-financial support from Novartis, Boehringer Ingelheim, CHIESI and EUROFARMA. Since August 2015, the KTU and BMJ have been engaged in a non-profit strategic partnership to provide continuous evidence updates for PACK, expand PACK-related supported services to countries and organisations as requested, and where appropriate license PACK content. The KTU and BMJ co-fund core positions, including a PACK Global Development Director, and receive no profits from the partnership. PACK receives no funding from the pharmaceutical industry. This paper forms part of a Collection on PACK sponsored by the BMJ to profile the contribution of PACK across several countries towards the realisation of comprehensive primary health care as envisaged in the Declarations of Alma Ata and Astana.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by the research ethics committee of the Federal University of Santa Catarina.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement No data are available.