There has been a lot of discussion lately around systematic reviews and RCTs on the effectiveness of MLD in our treatment mix. Measuring treatment outcomes is also a hot topic, with many therapists considering investing in expensive measuring devices.
But with the scientific community overly focused on study designs that don’t reflect our therapeutic approaches, and an inherent bias in health-care assessment favouring high-tech tools (read expensive and inaccessible), it is time to pause and take a breath, and rethink how we can affordably and sustainably measure clinically relevant outcomes to guide effective lymphoedema management.
The recent report by Lee et al, on 194 women affected by BCRL showed that quality of life (QOL) and limb size are not linked, concluding that
"changes in the size of lymphedema did not reflect changes in QOL. [..] A comprehensive approach [..] beyond reducing the size of lymphedema is recommended to improve QOL" (1).
So while we should absolutely keep our eye on size, we need to re-consider this as the primary goal of therapy, and differentiate between academically relevant outcomes, and clinically relevant outcomes. Research-needs and patient-needs are not always aligned.
Much academic research is driven by outcomes related to the funding source, or the needs and interests of higher degree students. In lymphoedema, this frequently fails to deliver usable information that we can take directly to the clinic and confidently use with the next client through the door. I have posted on this previously, and for the academically minded, you might like to read Rothman, 2014 (2).
The challenges that we face in problem solving, and advising our clients every day, are far too complex to be addressed by this kind of investigation.
It is also not economically achievable or sustainable for most therapists to invest in the high-tech measuring devices now available. Usually developed to meet research needs and generally more practical in institutional settings, they may accurately measure small changes in one or two very narrow parameters, but we need to assess multiple parameters within a given individual, as they present, in real time.
To be clinically relevant, an outcome measure must be driven by the client’s perspective so that the primary outcomes measure are QOL and ADLs. Measures such as limb circumference can be important secondary outcomes to back up and interpret changes in the lived experience. A new research model, investigating outcomes clinically relevant to people affected by lymphoedema, with the capacity to draw on the wealth of clinical observation that we hold as a therapist group, is overdue. We also need to find and use accessible and affordable client-centred measurement tools, so we can offer our clients the evidence-based therapy and advice that they deserve.
So how do we go about collecting clinically relevant evidence?
I was inspired by Sally Keir's report in Hobart on the Patient Activation Measure, and our case study group are considering using the Measure Yourself Medial Outcomes Profile (MYMOP®) to report on the effect of MLD on symptoms of long-COVID*. Using survey tools like these can provide clinically relevant measures on the effectiveness of your treatment which can guide both both you and the client. The annual licence fee is in the region of only a few hundred dollars, rather than the prohibitive upfront and ongoing costs associated with most high-tech devices.
Using validated tools also allows data aggregation and reporting across either multiple clients or multiple therapists. When we publish individual case studies using these validated measures, we provide the kind of data that can be used for academic investigation and analysis relevant to our clinical practice.
Over the next few posts, I will review a few of the available survey tools appropriate for use to monitor clinical progress in lymphoedema management, and provide a more relevant measure of how your therapy is progressing than any RCT can offer.
The Measure Yourself Medical Outcome Profile is a client-centred questionnaire that begins with the client nominating and describing the primary concern or problem, and then uses analogue scales to track changes over time.
Using such a tool to objectively track what is important to the client, for a small annual licence fee, seems like a good investment in measuring and guiding our clinical practice. You can still do your circumference measures and develop your palpation skills in assessing fibrosis etc to track skin and tissue changes, and we need to combine all these measures to ensure we achieve the primary outcomes of the individual.
The MYMOP® tool can be administered in-person or as an online web-form depending on your level of subscription. Read more about licencing options here. Whether you pay for the paper-based or digital portal versions, Meaningful Measures will provide support to help you administer the survey, and collect and analyse your data. Find out more at MYMOP®.
As a therapist community we need to find new ways to value and share the data generated from our collective clinical experience.
Many of us use therapist groups on social media, but this doesn't allow for aggregating or publishing more openly, the collective wisdom of the group.
The best way to do this is to publish our case studies.
If you are interested in learning how to write your own case report please join our case reporting group* as we teach ourselves how to publish case studies.
* Participants in the Case Report Project are eligible for a discounted rate on the purchase of a MYMOP® license.
References
Lee, H. S., Lee, H. J., & Seo, K. S. What Should We Focus on When Managing Breast Cancer-Related Lymphedema to Improve Quality of Life? Lymphatic Reseach Biology. doi:10.1089/lrb.2021.0009
Abstract
Background: Breast cancer-related lymphedema (BCRL) is correlated with poor quality of life (QOL). The effects of the management of lymphedema on QOL remain controversial. We analyzed the changes in QOL and identified factors associated with its improvement to improve the care of patients with BCRL.
Methods and Results: A total of 194 patients with BCRL were recruited, and their medical records were reviewed regarding type of surgery, chemotherapy, and radiation. Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, and the volume and circumference of lymphedema were measured. Significant improvements in physical, emotional, cognitive, social, and role functioning, and future perspective were observed after BCRL management. However, the change in the size of lymphedema was not correlated with the change in QOL parameters.
Conclusion: The management of BCRL has a beneficial effect on QOL. However, changes in the size of lymphedema did not reflect changes in QOL. Therefore, a comprehensive approach for the management of BCRL beyond reducing the size of lymphedema is recommended to improve QOL.
2. Rothman, K. J. (2014). Six persistent research misconceptions. J Gen Intern Med, 29(7), 1060-1064. doi:10.1007/s11606-013-2755-z
Abstract
Scientific knowledge changes rapidly, but the concepts and methods of the conduct of research change more slowly. To stimulate discussion of outmoded thinking regarding the conduct of research, I list six misconceptions about research that persist long after their flaws have become apparent. The misconceptions are: 1) There is a hierarchy of study designs; randomized trials provide the greatest validity, followed by cohort studies, with case–control studies being least reliable. 2) An essential element for valid generalization is that the study subjects constitute a representative sample of a target population. 3) If a term that denotes the product of two factors in a regression model is not statistically significant, then there is no biologic interaction between those factors. 4) When categorizing a continuous variable, a reasonable scheme for choosing category cutpoints is to use percentile-defined boundaries, such as quartiles or quintiles of the distribution. 5) One should always report P values or confidence intervals that have been adjusted for multiple comparisons. 6) Significance testing is useful and important for the interpretation of data. These misconceptions have been perpetuated in journals, classrooms and textbooks. They persist because they represent intellectual shortcuts that avoid more thoughtful approaches to research problems. I hope that calling attention to these misconceptions will spark the debates needed to shelve these outmoded ideas for good.