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Abstract
Background Within Parkinson’s disease (PD) management, a pivotal juncture often arises when individuals with PD (PwP) necessitate advanced therapies to stabilise symptom fluctuations and reduce off-periods, which are intrinsic to living with PD. One such intervention is the infusion of duodenal levodopa–entacapone–carbidopa intestinal gel (LECIG), which confers a more dependable levodopa plasma concentration compared with conventional oral therapy. It involves the insertion of a percutaneous endoscopic gastrojejunostomy (PEG-J) tube, facilitating direct access to the stomach and jejunum. Then, a slender tube extends into the small intestine, facilitating the continuous delivery of LECIG via a portable pump. The PEG-J incorporates an extension tube that permits patients with PD to connect the medication pump.
Objective The objective of this study was to assess and compare two types of extension tubes a standard; a standard tube and the ENFit extension tube.
Method Employing a prospective, crossover design at a single centre in Denmark. Each participant evaluated both extension tubes for 14 days. The primary outcome measure was patient-reported evaluation measures through a nine-item questionnaire using a 5-point Likert scale and 10th open-ended qualitative question.
Results Of the 12 recruited PwP, 10 successfully completed both testing periods and submitted self-reported questionnaires. The participants, with an average age of 70.3 years, comprised three men and seven women. Among them, five had a spouse or cohabitant, while five lived independently (with one residing in a nursing home). The average duration of PD diagnosis was 16.4 years, with an average of 2.6 years since the implantation of the medication pump. The ENFit tube outperformed the standard tube across all nine evaluation criteria, particularly excelling in terms of usability (items 4–6), safety (item 2) and overall product preference (item 9).
- Patient satisfaction
- Patient safety
- Quality improvement
- Self Care
- Patient education
Data availability statement
Data are available upon reasonable request.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
The existing body of knowledge on the utilisation of extension tubes in advanced treatment has established a foundation for understanding the complexities of managing Parkinson’s disease. Previous research has shed light on various aspects of the challenges associated with treatment with device-aided therapies. This study further illuminates the clinical consequences specifically related to the use of two different extension tubes in advanced treatment.
WHAT THIS STUDY ADDS
The explored research gap underscores the need for a focused investigation to provide a nuanced understanding of how extension tubes impact the overall efficacy and outcomes of advanced treatment strategies in Parkinson’s disease management. Identifying and addressing these clinical consequences can contribute significantly to refining therapeutic approaches and enhancing the quality of care for individuals affected by Parkinson’s disease.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
From a research perspective, it may lead to the development of targeted interventions and improved treatment protocols. In practice, understanding the clinical consequences can guide healthcare professionals in optimising patient care and tailoring treatment strategies. On a policy level, insights from such exploration could influence guidelines and regulations, fostering a more informed and patient-centric approach to managing Parkinson’s disease with advanced treatment modalities.
Introduction
Parkinson’s disease (PD) is a progressive, neurodegenerative disease. People with PD (PwP) exhibit heterogeneous clinical phenotypes, and there is a large variability in the symptoms.1 PwP are challenged by the classic motor symptoms; bradykinesia, rigidity and tremor, and in the moderate to severe stages, impairments in gait and balance.2
Fluctuations in symptoms due to complex response to medication can cause constant pendulum between periods in which PwP are able to move smoothly for some hours (on-state) and periods with increased motor symptoms (off-state).1 It is currently considered that off-periods in moderate PD stages are related to the wearing off of dopaminergic medication and that they can be relieved by keeping plasma levels of medication stable.3 4 Patients with advanced PD may experience a delayed response or no response to oral therapy, and maintaining a predictable plasma concentration of the drug can be challenging. Because of this, most PwP will eventually need advanced therapy aimed at stabilising symptom fluctuations and minimising off-periods.5 One such advanced therapy is duodenal levodopa–entacapone–carbidopa intestinal gel infusion (LECIG), which provides a more stable levodopa plasma concentration compared with oral therapy.6
LECIG treatment requires a surgical procedure, called a percutaneous endoscopic gastrojejunostomy (PEG-J) in order to insert a tube through the skin of the abdomen into the stomach/jejunum. A smaller tube then passes through this to the small intestine, allowing continuous delivery of LECIG via a portable pump. LECIG contains three active substances; levodopa, carbidopa and entacapone in a gel that travels through the portable pump and tube directly into the upper part of the intestine.6 7 The PEG-J has an extension tube in which the patient with PD can connect the medicine pump, and individually optimised dosing of LECIG is normally delivered over a 16-hour period.
Most common side effects of using the LECIG treatment are symptoms related to the implantation and maintenance of the PEG-J, typically signs of infection such as drainage, redness, swelling, pain, or feeling of warmth or itching around the small hole in the stoma. Common side effects related to the extension tubes are leakage, inflexibility of the connector/flow stoppage due to clogging, bending and kinks in the tube, failure of the connector parts and difficulty of operation with, for example, reduced fine motor skills.6 7
To deliver the best possible solution to PwP requiring LECIG treatment with regard to compliance, satisfaction, handling of the extension tube, safety, product preferences and user-friendliness, the aim of this study was to test and compare two types of extension tubes; a standard tube and the extension ENFit tube.
Methods
Study design
The study is a prospective, crossover quality study at a single centre in Denmark with inclusion of 10–12 PwP, where advanced treatment with LECIG has already been initiated. Each PwP tested the two extension tubes (14 days each) in a crossover design (figure 1).
Crossover design with 2-week testing period and evaluation for each tube.
Participants and setting
Initially, participants were informed and included at the Movement Disorder Clinic (MDC). The intervention was conducted at the MDC, Rigshospitalet, Denmark and participants’ private home from January to April 2023.
Inclusion criteria: age >18 years, advanced treatment (LECIG) initiated, independent of help or had access to technical pump support in their home, stage 3–5 on Hoehn and Yahr Scale,8 felt safe about management of the extension tubes, speak and understand Danish.
Exclusion criteria: not appropriate candidates for LECIG treatment (clinical evaluation), cognitively impaired evaluated by the Montreal Cognitive Assessment Scale9 score <23, diagnosed with depression, suffering from untreated psychosis/hallucinations.
Two PD nurses in the MDC screened all potential participants using purposeful inclusion based on the criteria and their relevance to the aim of the study (see flow chart in figure 2).
Flow chart of the inclusion process. LECIG, levodopa–entacapone–carbidopa intestinal gel; MDC, Movement Disorder Clinic; PwP, people with Parkinson’s disease.
Allocation
In this crossover study, the allocation method employed was randomisation. The participants were sequentially assigned to the tube sequences based on the order of enrolment. This random allocation aimed to distribute potential baseline differences evenly across the groups, enhancing the internal validity of the study. No stratification was used in this process, as the primary focus was on achieving a balanced allocation of participants to tube testing sequences.
Intervention
Participants were asked to test the ENFit tube and the standard extension tube subsequently for a 2-week period each in random order. Two PD nurses from the MDC visited the participants’ home twice during the project period for instructions in reporting signs of leaks, registration of adverse events, data collection, and for safety and motivational purposes (figure 1).
Extension tube ENFit
The ENFit tube is a silicon, kink-resistant tube and with wings on the connectors to ease assembly and disassembly. It can be connected to PEG-J devices to be used for manual delivery of LECIG to PEG-J tubes by use of the ENFit syringe.9 The tube is equipped with connectors, and is available in 15, 20 and 30 cm lengths. In this study, the 20 cm length was used. The wings on the connectors are designed to enable ease of adding rotational force during connections. If the PwP were not able to do so, the caregiver or primary nurse was instructed to handle this.
Data collection
Data regarding demographics and clinical evaluation were collected at visit 1 by the PD nurses and reported descriptively. Project manager (THT) was blinded during the participant group allocation, intervention and data collection.
Primary outcomes
Self-reported key performance indicators (KPIs) were used as the primary outcome to evaluate the product on a nine-item questionnaire using a 5-point Likert scale with visual ‘smileys’. Questions were containing (1) overall satisfaction, (2) safety, (3) activity, (4–6) usability, (7) self-efficacy/compliance, (8) skin sensitivity, (9) product preference. A 10th open-ended qualitative question was included at the end giving the participants the opportunity to express their elaborated opinions about both the tubes.
The KPIs were collected as patient-reported evaluation measures (PREMs data) in a self-reported evaluation form created in SurveyXact (ID=1499269).
Secondary outcome measure
Side effects/adverse events were registered by the PD nurses during the intervention period and also reported in the PREM questionnaire.
Analysis
All analyses were conducted in SurveyXact and bar plots were automatically generated. The answers concerning the last item, the open-ended question, were gathered and listed under the two groups.
Results
12 PwP were recruited, and 10 participants completed both the testing periods (4 weeks in total) and filled out the self-reported questionnaires (see flow chart in figure 2). The participants were on average 70.3 years old, three men and seven women; five had a spouse/cohabitant and five lived alone (one at a nursing home). The average duration of PD diagnosis was 16.4 years, with an average of 2.6 years since the implantation of the medication pump (table 1).
Characteristics and baseline data of the participants
Figure 3 illustrates the differences between the participants’ subjective experiences and evaluations of using the two tubes. The ENFit tube was evaluated by the participants as the most suitable on all the nine-item scores compared with the standard tube, especially on usability (items 4–6), safety (item 2) and product preference (item 9).
Results from the nine-item PREM questionnaire comparing the standard tube and the ENFit tube. Below, the reported comments from the qualitative, open-ended question are displayed. PREM, patient-reported evaluation measure.
Discussion
With this quality project, we wanted to be able to conclude which tube is the most suitable according to safety, usability, patient preferences, management and compliance. The ENFit tube was evaluated by the participants as the most suitable on all the nine-item scores compared with the standard tube. Also, the responses to the qualitative question indicate that the ENFit tube is considered as the one with less side effects and complications when handling the LECIG pump during everyday life.
In our population, the ENFit extension medicine tube was a significant advancement in addressing the unique challenges faced by PwP receiving LECIG treatment. One of the prominent advantages lies in its ease of use reported by the participants, which is of vital importance for individuals with motor impairments characteristic of advanced PD. Furthermore, the secure locking mechanism, with different colours included, of the ENFit connector may prevent unintended disconnections, reducing the likelihood of interruptions in medication delivery, a crucial concern for patients heavily reliant on accurate and continuous dose administering.10
In addition to these practical advantages, the ENFit extension tube also addresses the discomfort and potential complications associated with prolonged usage. Individuals in the advanced stages of PD often experience involuntary movements, making it challenging to maintain a stable position during medication administration,1 which stresses the importance of the tube being easy to use and designed properly. This is an important factor looking into the future organisation of the Danish healthcare system, where more and more responsibility within own treatment, management of symptoms and engagement in general care is being put on the patients and caregivers.11 Use of the ENFit tube seems to mitigate the strain on both patients and caregivers, enhances the quality of care and also fosters a feeling of greater independence and well-being for both patients and their caregivers based on the answers from the open-ended question.
Limitations
Some limitations due to sample size and design must be considered.
The small sample size may limit the generalisability of the findings to a broader population of individuals with PD. Thus, the study results may not be representative of the diversity within the larger patient population, and caution should be exercised when interpreting the results.
Some order effects may also be considered as the order in which the tubes were administered may have influenced outcomes independently of the tubes themselves. The participants may have responded differently to the tubes depending on whether which one was given first or second in the testing sequence.
Moreover, the inclusion of design strategies, such as a ‘washout period’, could have been beneficial in alleviating potential carryover effects between the study periods. Instead, the two extension tubes were tested in an ongoing period of 14 days each. Nevertheless, it is important to note that achieving a complete elimination of carryover effects poses a significant challenge in the context of a crossover study.
Conclusion
In our study, the benefits of the ENFit extension medicine tube in individuals with advanced PD are evident in its design, improved ease of use and enhanced safety features, and it seems to be a promising instrument in medication management compared with standard tubes. Therefore, this tube will be integrated in future care planning for PwP with advanced phase when focusing on home-based treatment. However, the small sample size requires that the results must be interpreted with caution.
Data availability statement
Data are available upon reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
This study involves human participants. As the study is a quality development study conducted to change clinical practice, an approval from the Ethics Committee in the Capitol Region of Copenhagen was not concluded necessary. The study conformed to the ethical principles defined in the Declaration of Helsinki. All participants received written and/or oral information about the study before giving consent.
Acknowledgments
We would like to thank all the participants and their relatives who contributed to this study.
Footnotes
Contributors THT acted as a guarantor and accepts full responsibility for the work and/or the conduct and conceptualization of the study. THT had access to data, and controlled the decision to publish. THT analysed the data and wrote the first draft of the manuscript. LO co-designed the study, collected data and revised the first draft of the manuscript. MJ co-designed the study, collected data and revised the first draft of the manuscript. NFLCK co-designed the study and revised the first draft of the manuscript. BB-S conceptualised and co-designed the study, and revised the first draft of the manuscript.
Funding This work was supported by the Neurological Department, Rigshospitalet Glostrup, and from an unrestricted grant from Innoventa Medica (no award/grant number).
Disclaimer The financial support does not in any way influence the objectivity, integrity or impartiality of our research findings, and the study has been conducted with scientific rigour and transparency.
Competing interests BB-S has received honoraria from serving on the scientific advisory board for AbbVie and Britannia Pharmaceuticals, and has received fees for speaking at conferences from AbbVie and Merz Therapeutical. THT and BB-S have previously received research support from AbbVie. The other authors declare that there is no conflict of interest relevant to this work.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.