Background

A scientifically placed/published article “Resnik LJ, Borgia ML, Clark MA, Graczyk E, Segil J, Ni P. Structural validity and reliability of the patient experience measure: A new approach to assessing psychosocial experience of upper limb prosthesis users. PloS One. 2021 Dec 28;16(12):e0261865” appeared recently [1].

Premise of article

The rather promising premise is that they want to “measure” via questionnaire, how well arm amputees cope with “modern” prosthetic technology.

The choice of questions appears really peculiar to me, so I will review these in more detail below. Conversely, the authors conveniently seem to forget relevant questions regarding particularly relevant disadvantages of “modern” prostheses, as well as general relevant questions regarding other, more established, more valued and prevailing prosthetic builds other than what they call “modern”.

Also, it is just a questionnaire, so the researchers end up with the amputees’ self assessments.

Cited from article as premise

“Recent advances in upper limb prosthetics include sensory restoration techniques and osseointegration technology that introduce additional risks, higher costs, and longer periods of rehabilitation.  (..) New technologies and surgical techniques are being developed to enable higher degree of freedom movement, more intuitive control, and restoration of sensory feedback to upper limb prosthesis users, and these advances have the potential to greatly improve quality of life. However, these recent advancements are also associated with greater risks, higher costs, and longer periods of rehabilitation. (..) The PEM [patient experience measure] can be leveraged to study the impact of newer interventions available in the field of upper limb prosthetic research, such as osseointegration, targeted muscle reinnervation, regenerative peripheral nerve interfaces, and peripheral nerve stimulation. For example, future research can compare how sensory restoration techniques affect the sense of embodiment relative to conventional prosthetic devices or how osseointegration affects the intuitiveness of prosthesis use compared to conventional prosthetic sockets.”

Aim of article

The aim of the article is to inform, with specific relation to new technologies, and there, explicitly, with relation to sensory restoration techniques, osseointegration technology, targeted muscle reinnervation, regenerative peripheral nerve interfaces, and so on. The article carries on to lay down its intended goal by stating this:

“Therefore, it is important to understand the benefits and limitations of new prosthetic technologies using validated outcome measures to help clinicians and patients make decisions about prosthesis options” (..) “To inform regulatory and clinical decision making, validated patient reported outcome measures are required to understand the relative benefits of these interventions. The Patient Experience Measure (PEM) was developed to quantify psychosocial outcomes for research studies on sensory-enabled upper limb prostheses.”

Critical comment

A relevant aspect here to me seems that the article, as it is written, wants to study “the impact of newer interventions” and not, as we shall see as actually being realized inside the questionnaire PEM, “just some, but not all, and, in particular, no difficult/ negative aspects, with regard to impact, of newer interventions“.

Border to epistemic issues related to amputee subpopulation

To not ask questions about all aspects that contribute to the extra burden of being a test person for new technology seems to have history, also in the context of “modern / newer interventions”, in that Resnik et al. (2021) do not seem to be the only or first ones to conveniently leave out and omit such aspects from their reports with regard to amputee rehabilitation [2].

This points to the possibility of epistemic problems with regard to the amputee subpopulation as such. So it seems fair to look outside the domain of limb amputation related studies in order to argue the relevance of some wider aspects of these “newer interventions”.

Real factors to be considered for such an article

Real factors to be considered to dampen or outweigh a positive impact of “newer interventions”, which this manuscript does not mention at all, are the following factors:

• osseointegration installs a bolt into the thin forearm bones (for below elbow amputation, that is), and then the allowed torque tends to be restricted (see about torque related restrictions [link]); sooner or later, this tends to become a very practical issue, to be considered also for questionnaires;
• osseointegration installs a chronic wound (‘stoma’) that first of all poses exposure-related lifestyle restrictions (such as public swimming pools with ‘as-is’ water quality); if the questionnaires do not routinely cover such aspects, the chance seems realistic the authors do not even know amputees that life such lifestyles; osseointegration ‘stoma’ requires at least once per day ‘cleaning’, which amounts to daily wound care; now, any such chronic wound as such may want to be considered as that by health professionals, and it may require specific care, also regarding mental health ¹ [3]; people with (chronic) wounds tend to have “lower mean scores in the wound group than the non-wound group in Health Related Quality of Life (HRQoL) with significant difference noted in physical functioning, social functioning, emotional and physical roles” [4];
• osseointegration tends to be privately paid, as the follow-up care for complications, custom prostheses and so on, are all possibly not covered by any insurance, so by and large one may require a dedicated funds of what I personally would estimate to realistically range around 200’000 to 400’000 USD, to be ready for this;
• osseointegation will take out whole time-chunks of the amputee’s life, first about a year until the thing can be loaded, then secondly after all the fractures over the “life” of an implant, and with all the infections (e.g. [5]);
• osseointegration, targeted muscle reinnervation and neural implants may require at least one extra surgery to just start with; that alone is relevant;
• targeted muscle reinnervation makes little / small / defined skin surfaces the places where the electrodes need to sit with precision; instead of two ill-bounded large forgiving skin areas where to place two electrodes (usually one for opening, one for closing the device), the skin then offers many well defined and localized places that are really small, exactly where the electrodes need to be placed; the burden on socket fit precision may be estimated to be entirely significant; so no wiggle or minimal misalignment will be tolerated;
• the control error for osseointegrated prosthetic mounts will not be better than normal myoelectric technology as there are no fundamental control differences; there, invasively installed neural interfaces are the new intervention that presents a promise but the study under review here seems to leave out some of the more frequent complicating issues; with regard to neural function surgery in one study, it may be interesting to see that of 1779 records related to surgical optical nerve stimulation, there were 1233 adverse event records: 822 surgically manageable postoperative complications, 121 device malfunctions, 29 patient compliance issues and 27 intraoperative complications [6]; also, long term stability of neural implants seems not established, while it is written that “conventional methods such as intra- and extra-neural electrodes are challenging for long term interface due to the inherent trauma and subsequent fibrosis induced by the implant itself that lead to signal deterioration over time” [7];
• extra surgery may entail also postoperative pain, infectious risk, bleeding risk, risk of nerve damage, as well as cost, and functional down time; so it seems legit to cover that in that type of questionnaire;

The possibly massive extra cost and possibly relevant extra risk and complications have to be named, presented, listed and documented, and put into perspective of actual function, performance, correct control rate versus error rates and reliability, comfort and durability, as well as maintenance cost; so questionnaire questions will need to necessarily address all of these aspects in order to give a balanced light.

As stated already: that is not the “current trend”.

The “current trend” of academic and self-proclaimed prophets is to praise “modern” devices and to vilify “established” devices, without any apparent reflection about real life aspects from real users that deliver real work. That seems to be the last thing they have on their radar.

Hence, a review such as this that is in order. With the people that author such texts being in “powerful” positions, the epistemic aspect becomes relevant.

Article questions and their relevance rating from my view

The questionnaire as cited from “Resnik LJ, Borgia ML, Clark MA, Graczyk E, Segil J, Ni P. Structural validity and reliability of the patient experience measure: A new approach to assessing psychosocial experience of upper limb prosthesis users. PloS one. 2021 Dec 28;16(12):e0261865” [1] and my comments and subjective ratings:

Total: 34 out of 340 score points for relevance; overall subjective relevance ~0,1 [0-1,0].

Suggestion for better questions

I can easily suggest a few better questions, here they are.

But interesting to see what people write up these days.

With decreasing relevance from a real user view comes an increase in splitting our worlds – what I always said: these, and we, we live on different planets, we do not just work in different buildings. They do not care 1 bit if I pay 200 000 $ cash for a “newer intervention” that causes me > 1 year of dead time. They do not even have a single question about such.

So what is this published questionnaire really about? Helping the amputee find a best solution? That seems not likely; for that, prosthetic arm aspects of real life relevance would populate this questionnaire as commented above. Helping the prosthetist find a best technical solution? Nah, not nearly sufficiently practical. Helping a surgeon find the best nerves or TMR options? No, not practical enough. Helping insurances navigate among “newer interventions”? Nope, not relevant and not technical enough.

So who could be the real stakeholder for this questionnaire? Could by exclusion only be academics, and there, just those that wish to somewhat glorify certain aspects of these “newer interventions”, but really not all or even the most pressing aspects from a user view – OH NO!

Thus it seems that where these authors are headed, is the high academic impact, the journals of the level of Lancet, NEJM and Nature – and, as far away from the tool shed as possible. To move away from the real and to move towards the symbolic.

Maybe, as intermission, read about Thorstein Veblen now [link].

@article{resnik2021structural,
  title={Structural validity and reliability of the patient experience measure: A new approach to assessing psychosocial experience of upper limb prosthesis users},
  author={Resnik, Linda J and Borgia, Mathew L and Clark, Melissa A and Graczyk, Emily and Segil, Jacob and Ni, Pengsheng},
  journal={PloS one},
  volume={16},
  number={12},
  pages={e0261865},
  year={2021},
  publisher={Public Library of Science San Francisco, CA USA}
}

@article{lundberg2011my,
  title={My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb},
  author={Lundberg, Mari and Hagberg, Kerstin and Bullington, Jennifer},
  journal={Prosthetics and Orthotics International},
  volume={35},
  number={2},
  pages={207--214},
  year={2011},
  publisher={SAGE Publications Sage UK: London, England}
}

@article{upton2012mood,
  title={Mood disorders in patients with acute and chronic wounds: a health professional perspective},
  author={Upton, Dominic and Hender, Carole and Solowiej, Kazia},
  journal={Journal of Wound Care},
  volume={21},
  number={1},
  pages={42--48},
  year={2012},
  publisher={MA Healthcare London}
}

@inproceedings{ousey2014exploring,
  title={Exploring resilience when living with a wound—an integrative literature review},
  author={Ousey, Karen and Edward, Karen-leigh},
  booktitle={Healthcare},
  volume={2},
  number={3},
  pages={346--355},
  year={2014},
  organization={Multidisciplinary Digital Publishing Institute}
}

@article{palmquist2008forearm,
  title={Forearm bone-anchored amputation prosthesis: a case study on the osseointegration},
  author={Palmquist, Anders and Jarmar, Tobias and Emanuelsson, Lena and Br{\aa}nemark, Rickard and Engqvist, H{\aa}kan and Thomsen, Peter},
  journal={Acta Orthopaedica},
  volume={79},
  number={1},
  pages={78--85},
  year={2008},
  publisher={Taylor \& Francis}
}

@article{doran2018investigating,
  title={Investigating complications associated with occipital nerve stimulation: a MAUDE study},
  author={Doran, Joseph and Ward, Max and Ward, Brittany and Paskhover, Boris and Umanoff, Michael and Mammis, Antonios},
  journal={Neuromodulation: Technology at the Neural Interface},
  volume={21},
  number={3},
  pages={296--301},
  year={2018},
  publisher={Wiley Online Library}
}

@article{blasiak2021steer,
  title={STEER: 3D Printed Guide for Nerve Regrowth Control and Neural Interface in Non-Human Primate Model},
  author={Blasiak, Agata and Ng, Kian Ann and Wong, Dian Sheng and Tsai, Chne-Wuen and Rusly, Astrid and Gammad, Gil Gerald Lasam and Voges, Kai and Libedinsky, Camilo and Yen, Shih-Cheng and Thakor, Nitish V and others},
  journal={IEEE Transactions on Biomedical Engineering},
  year={2021},
  publisher={IEEE}
}