scholarly journals Developing an Initial Program Theory to Explain How Patient-Reported Outcomes Are Used in Health Care Settings: Methodological Process and Lessons Learned

2020 ◽  
Vol 19 ◽  
pp. 160940692091629
Author(s):  
Rachel Flynn ◽  
Kara Schick-Makaroff ◽  
Adrienne Levay ◽  
Joanne Greenhalgh

A central aspect of any theory-driven realist investigation (synthesis or evaluation) is to develop an initial program theory (IPT). An IPT can be used to frame and understand how, for whom, why, and under what contexts complex interventions work or not. Despite well-established evidence that IPTs are a central aspect to any realist investigation, there is wide variation and a lack of methodological discussion on how to develop an IPT. In this article, we present the approach that we used to develop an IPT of how patient-reported outcomes (PROs) are used in health care settings. Specifically, we completed a systematic review to extract tacit theories reported in the literature. The benefit of this approach was that it provided a rigorous review of the literature in the development of IPTs. The challenges included (1) rediscovering what is already well established in the theoretical literature, (2) generating an overabundance of partial candidate theories, and (3) extensive use of time and resources for what was the first stage to our larger funded research study. Our recommendations to other scholars considering this approach are to ensure that they (1) live within their means and (2) narrow the scope of the research question and/or develop a conceptual framework using middle-range theories. These methodological insights are highly relevant to researchers embarking on a realist investigation, tasked with developing an IPT.

2019 ◽  
Vol 27 (3) ◽  
pp. 241-248 ◽  
Author(s):  
Carolyn Steele Gray ◽  
James Shaw

Purpose Models of integrated care are prime examples of complex interventions, incorporating multiple interacting components that work through varying mechanisms to impact numerous outcomes. The purpose of this paper is to explore summative, process and developmental approaches to evaluating complex interventions to determine how to best test this mess. Design/methodology/approach This viewpoint draws on the evaluation and complex intervention literatures to describe the advantages and disadvantages of different methods. The evaluation of the electronic patient reported outcomes (ePRO) mobile application and portal system is presented as an example of how to evaluate complex interventions with critical lessons learned from this ongoing study. Findings Although favored in the literature, summative and process evaluations rest on two problematic assumptions: it is possible to clearly identify stable mechanisms of action; and intervention fidelity can be maximized in order to control for contextual influences. Complex interventions continually adapt to local contexts, making stability and fidelity unlikely. Developmental evaluation, which is more conceptually aligned with service-design thinking, moves beyond these assumptions, emphasizing supportive adaptation to ensure meaningful adoption. Research limitations/implications Blended approaches that incorporate service-design thinking and rely more heavily on developmental strategies are essential for complex interventions. To maximize the benefit of this approach, three guiding principles are suggested: stress pragmatism over stringency; adopt an implementation lens; and use multi-disciplinary teams to run studies. Originality/value This viewpoint offers novel thinking on the debate around appropriate evaluation methodologies to be applied to complex interventions like models of integrated care.


2016 ◽  
Vol 3 (3) ◽  
pp. 168 ◽  
Author(s):  
Heather Tabano ◽  
Thomas Gill ◽  
Kathryn Anzuoni ◽  
Heather Allore ◽  
Ann Gruber-Baldini ◽  
...  

2015 ◽  
Vol 39 (6) ◽  
pp. E17 ◽  
Author(s):  
Scott L. Parker ◽  
Anthony L. Asher ◽  
Saniya S. Godil ◽  
Clinton J. Devin ◽  
Matthew J. McGirt

OBJECT The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care. METHODS All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months. RESULTS A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p < 0.0001) and ODI (r = 0.70; p < 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10.5% of patients who did not meet the MCID threshold at 3 months continued to improve and ultimately surpassed the MCID threshold at 12 months. For ODI, achieving MCID at 3 months accurately predicted 12-month MCID with only 62.6% specificity and 86.8% sensitivity. For postoperative health utility (EQ-5D), 8.5% of patients lost an MCID threshold improvement from 3 months to 12 months, while 4.0% gained the MCID threshold between 3 and 12 months postoperatively. For EQ-5D (quality-adjusted life years), achieving MCID at 3 months accurately predicted 12-month MCID with only 87.7% specificity and 87.2% sensitivity. CONCLUSIONS In a prospective registry, patient-reported measures of treatment effectiveness obtained at 3 months correlated with 12-month measures overall in aggregate, but did not reliably predict 12-month outcome at the patient level. Many patients who do not benefit from surgery by 3 months do so by 12 months, and, conversely, many patients reporting meaningful improvement by 3 months report loss of benefit at 12 months. Prospective longitudinal spine outcomes registries need to span at least 12 months to identify effective versus noneffective patient care.


2018 ◽  
Vol 33 (6) ◽  
pp. 649-656 ◽  
Author(s):  
Kerri Bell ◽  
Eugene Warnick ◽  
Kristen Nicholson ◽  
Sarah Ulcoq ◽  
Seong Jin Kim ◽  
...  

Health care increasingly collects patient-reported outcomes (PROs) via web-based platforms. The purpose of this study was to evaluate how patient age influences portal engagement. Patients undergoing elective surgery at a single multispecialty orthopedic practice from September 2014 to February 2017 had access to an online portal to complete PROs, message the clinic, and view physical therapy instructions. A mobile app was optionally available. Age, sex, log-in frequency, PRO completion rates, and number of messages sent were reviewed retrospectively. Message frequency, log-in rates, and PRO compliance were highest for patients aged 41 to 50, 51 to 60, and 61 to 70, respectively. Mobile app use decreased with age ( P = .002); yet, at all ages, the mobile app group was more engaged. In particular, for patients aged 18 to 30 years, log-in frequency increased 2.5-fold and PRO compliance improved 44% ( P < .001) in the mobile app group. This study demonstrates that portal interaction varies by age and that data capture is highest in patients who choose the mobile app.


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