How were the PROactive tools developed?

Concise summary

The instruments were developed by an European consortium including academic partners with expertise in qualitative and quantitative COPD research, together with the pharmaceutical industry. After careful study of the existing literature (Williams PMID 22414164; Frei PMID 2218560; Gimeno Santos PMID 24558112), as well as the patients’ needs and the wording used by patients around their experience with physical activity, a first version of the conceptual framework and items was designed to capture that experience (Dobbels et al ERJ PMID: 25034563). In parallel, selected (Van Remoortel IJBNT PMOD 22776399) activity monitors were scrutinized for their validity in assessing physical activity in the laboratory as well as in real life (Van Remoortel  22745715; Rabinovich PMID 23397303).

Next, the tool was fine tuned in an initial validation study across different sites in Europe. The final PROs were developed in a daily version for clinical paradigms where rapid change is expected, or a clinical visit version, more adapted for patients in a clinically stable state (Gimeno-Santos PMID 26022965).

The tools include items in a dimension of experienced amount of physical activity (including two items directly derived from activity monitors and more classic questionnaire items) and items in the domain of difficulties with physical activity. A total score summarizes the patient’s full experience with physical activity. The tool was subsequently validated in a set of intervention studies, including pharmacotherapy (Troosters PMOD 29664681; Watz 28883722), as well as behavior change programs (Demeyer et al 28137918) and pulmonary rehabilitation. These studies collectively showed the validity and responsiveness of the C-PPAC and D-PPAC tools (Garcia Aymerich PMID 33479044). Along the developmental axis, input of the European Regulator (EMA) was regularly sought, which led to a favorable qualification opinion for the PRO by EMA.

Subsequently translation efforts have been undertaken by independent investigators (Santana 37610957) and the tool has been used in other studies (e.g. Mohan 36283827)

Phase 1. Understanding the need

The development of the PROactive instruments started with a literature search. A team of researchers looked at the existing conceptual frameworks on physical activity in patients with chronic diseases, trying to identify determinants and outcomes of physical activity1,2. This literature review showed that (i) no valid instruments or scales existed at the time that could comprehensively capture physical activity from the perspective of people with COPD; (ii) physical activity is associated with reduced mortality and risk of exacerbations; and (iii) there is still missing evidence on the determinants of physical activity.

In parallel, a qualitative study of people with COPD was carried out with the aim of understanding the experience of physical activity3 as described by those living with the condition. Participants highlighted three major themes during this study: (i) the impact that COPD has on the amount of physical activity, (ii) the symptoms experienced during physical activity, and (iii) the adaptations needed to facilitate physical activity. When these findings were combined with input from experts (clinicians, epidemiologists, etc), we obtained a novel conceptual framework of the physical activity experience in COPD3.

The evidence collected made clear that, to fully assess the physical activity of people with COPD, it is fundamental to combine objective and subjective measures. This is achieved by the PROactive instruments by combining an activity monitor assessment with a Patient Reported Outcome (PRO) questionnaire.

Aside from exploring the evidence on the validity of activity monitors to objectively measure physical activity4, we conducted two studies to select the most suitable activity monitors to be used as part of the PROactive instruments5,6. Based on our findings, we ended up selecting two activity monitors: the DynaPort MoveMonitor (McRoberts, the Hague, The Netherlands) and the Actigraph GT3X (ActiGraph Corporation, Pensacola, FL). Both devices are graded as medical devices, can easily be integrated in clinical trials, and provide minute by minute data and data aggregated by day on steps and Vector Magnitude Units.

Phase 2. PROactive clinical validation study

Based on the abovementioned studies (developed as part of the PROactive project), two PROactive draft questionnaires were designed with a daily (daily) and 7-day (clinical) recall. To validate the questionnaires and their combination with the activity monitors, a six-week multi-centre study was conducted (NCT01388218). It included 236 people with COPD with different levels of disease severity from five European cities7. As part of the studies and the validation process, the instruments were subject to item reduction and modifications until reaching their final versions. In this study also a one year follow-up visit was foreseen to provide information on decline of physical activity over time. In that study the importance of (repeated) exacerbations became apparent (Demeyer et al PMID 29371385).

Phase 3. Additional studies conducted

The final PROactive instruments were then tested for their reliability, validity and responsiveness. A total of six studies were conducted; three studies were led by the Academic partners (non-pharmacological interventions); and three studied were led by the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners to validate the PROs longitudinally.

For more information on the individual studies, please check the Publications.

References

  1. Gimeno-Santos E, Frei A, Dobbels F, Rüdell K, Puhan MA, Garcia-Aymerich J. Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: A systematic review. Health Qual Life Outcomes [Internet]. 2011;9(1):86. Available from: http://www.hqlo.com/content/9/1/86
  2. Gimeno-Santos E, Frei A, Steurer-Stey C, De Batlle J, Rabinovich RA, Raste Y, et al. Determinants and outcomes of physical activity in patients with COPD: A systematic review. Thorax. 2014;69(8):731–9. 
  3. Dobbels F, de Jong C, Drost E, Elberse J, Feridou C, Jacobs L, et al. The PROactive innovative conceptual framework on physical activity. Eur Respir J. 2014;44(5):1223–33. 
  4. Van Remoortel H, Raste Y, Louvaris Z, Giavedoni S, Burtin C, Langer D, et al. Validity of six activity monitors in chronic obstructive pulmonary disease: A comparison with indirect calorimetry. PLoS One. 2012;7(6):1–11. 
  5. Van Remoortel H, Giavedoni S, Raste Y, Burtin C, Louvaris Z, Gimeno-Santos E, et al. Validity of activity monitors in health and chronic disease: a systematic review. Int J Behav Nutr Phys Act. 2012;9. 
  6. Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, et al. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013;42(5):1205–15. 
  7. Gimeno-Santos E, Raste Y, Demeyer H, Louvaris Z, Jong C de, Rabinovich RA, et al. The PROactive instruments to measure physical activity in patients with chronic obstructive. Eur Respir J. 2015;46(4):988–1000. 
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