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At-home blood self-sampling in rheumatology: a qualitative study with patients and health care professionals

Abstract

Background

The goal of the study was to investigate patients’ with systemic rheumatic diseases and healthcare professionals’ experiences and preferences regarding self-sampling of capillary blood in rheumatology care.

Methods

Patients performed a supervised and consecutive unsupervised capillary blood self-collection using an upper arm based device. Subsequently, patients (n = 15) and their attending health care professionals (n = 5) participated in an explorative, qualitative study using problem-centered, telephone interviews. Interview data were analyzed using structured qualitative content analysis.

Results

Interviewed patients reported easy application and high usability. Patients and health care professionals alike reported time and cost savings, increased independence and flexibility, improved monitoring and reduction of risk of infection during Covid-19 as benefits. Reported drawbacks include limited blood volume, limited usability in case of functional restrictions, and environmental concerns. Older, immobile patients with long journeys to traditional blood collection sites and young patients with little time to spare for traditional blood collection appointments could be user groups, likely to benefit from self-sampling services.

Conclusions

At-home blood self-sampling could effectively complement current rheumatology telehealth care. Appropriateness and value of this service needs to be carefully discussed with patients on an individual basis.

Trial Registration

WHO International Clinical Trials Registry: DRKS00024925. Registered on 15/04/2021.

Peer Review reports

Introduction

Rising global burden of systemic rheumatic diseases (SRDs) manifests itself in mortality, disability-adjusted life expectancy [1], reduced quality of life [2] as well as direct and indirect health care costs, including absence from work and productivity [3, 4]. The high demand of rheumatology care is opposed by an inadequate number of rheumatologists [5], resulting in diagnostic delays [6] and often consecutive irreversible damage [7]. Covid-19 additionally aggravated this diagnostic delay [8] and the imminent risk of infection lead to a reduction of face-to-face consultations, shift to remote patient care [9] and self-management of patients [8].

Implementation of patient self-management [10] and telehealth strategies [11] could relieve rheumatology care, by accelerating diagnosis [12,13,14] and enabling a more flexible, need-based patient monitoring [15,16,17,18]. Despite the immense significance of laboratory results in rheumatology and the established role of patient self-sampling in the monitoring of other chronic diseases [19, 20], routine rheumatology care does not encompass patient self-sampling yet. However, a recent survey depicted the willingness of rheumatologists and rheumatic patients to incorporate self-sampling into routine care [21] and first rheumatology-based pilot studies highlighted the potential to monitor drug levels [22] and predict disease flares [23] using traditional finger prick devices. Recent trials proved that new upper-arm-based capillary blood self-collection devices such as the Tasso + and TAP II allow practically painless and reliable automatic collection of capillary blood [24,25,26]. However, these findings cannot be directly applied to rheumatology care as the studies involved distinct patient populations and laboratory parameters.

In a previous randomized controlled trial [27] we compared the acceptance of traditional finger pricking to an upper-arm based device (Tasso-SST) in patients with rheumatoid arthritis. While experienced pain was similarly low in both groups, the upper-arm group was more likely to recommend self-sampling (net promoter score: + 28% vs. -20%) and more willing to perform blood collection at home (60% vs. 32%).

In a consecutive trial we sought to compare two upper arm devices in a more diverse group of patients with systemic rheumatic diseases (SRD). We included an embedded qualitative study to gain in-depth feedback, as to our knowledge, no qualitative study has yet evaluated patient and care provider’s perceptions of capillary blood self-sampling in rheumatology.

The aim of the present qualitative study was therefore to explore SRD-patients' and health care professionals’ (HCP) experiences and preferences regarding at-home capillary blood self-sampling in rheumatology care:

  • How do patients and HCP experience upper arm based capillary blood self-sampling?

  • Which benefits and drawbacks exist?

  • How do patients and HCP assess the transferability of blood self-sampling to standard rheumatology care?

Methods

We carried out a prospective study to evaluate the feasibility, accuracy, pain, usability and acceptability regarding self-collection of capillary blood for analysis of autoantibodies and inflammation markers in patients with SRD. The study was prospectively registered on 15/04/2021 (WHO International Clinical Trials Registry: DRKS00024925), approved by the local ethics authorities (Reg no. 320_20B) and designed together with three official patient partners (GB, MK, CE; Deutsche Rheuma-Liga Bundesverband e.V). Patients and HCP provided written informed consent prior to participating in the study.

Consecutive patients with a systemic rheumatic disease and previously documented SRD associated autoantibodies were recruited from the in- and outpatient clinics of the Department of Rheumatology at the University Hospital Erlangen. The study team alternately allocated patients to one of two upper-arm based blood collection devices, Tasso + (Tasso Inc., Seattle, WA, USA) or TAP II (YourBio Health, USA), and performed one supervised and one unsupervised blood collection with the respective device (Fig. 1) [28].

Fig. 1
figure 1

Study flow and main blood self-collection steps

Prior to the supervised blood collection patients were given access to written instructions and an instructional video (Tasso + : https://www.tassoinc.com/tasso-plus; TAP II: https://bit.ly/3HCngxK).

One medical student (JZ) supervised all blood collection procedures, ensuring that each step of the self-collection procedure was performed correctly, intervening only in the event of potential harm or failure. Study personnel intervention was registered in 6 of 35 (17%) and 8 of 35 (22%) in the Tasso + and TAP II group, respectively [27]. After the supervised blood collection, patients received blood collections kits and postage packages to independently carry out a second blood collection within one week of the appointment. In contrast to traditional finger-prick devices, both devices are upper-arm-based and allow automatic blood-collection. The self-adhesive devices can be attached to the upper arm and by pressing a button the skin is perforated. Capillary blood is then automatically retrieved in the attached collection tube. After blood collection, the collection tube can be removed from the blood collection device and sent via conventional postage to a laboratory for analysis. To gain in-depth detailed feedback regarding perception of self-sampling of capillary blood in rheumatology care, patients and HCPs were invited to participate in a qualitative interview study. Patients were selected using purposive sampling [29] to include a heterogeneous sample regarding age, disease duration, as well as professional and educational backgrounds. HCPs were selected based on their experience with self-sampling of capillary blood in rheumatology care, as treating physicians or being part of the study team in the prospective study.

Interviews were conducted using a structured interview guide that was developed to specifically elicit the participants’ experiences collecting capillary blood independently and unsupervised. The structured interview guide was developed by two health service researchers (FM, SM), one rheumatologist (JK) and previous discussions with three patient research partners (GB, MK, CEA). The interview guides (Supplemental Material 1 & 2) included the following main topics: feasibility of self-sampling, benefits and drawbacks, and transferability to standard care. Initial exploratory questions were then specified by follow-up questions. FM conducted pilot interviews (Patients 1 & 2 and HCP 1) to test and refine the interview guide. No revisions were necessary. The data of the pilot interviews were thus included in the analysis. Additional sociodemographic data were collected, including gender, age, diagnosis, education and profession. In order to reduce the risk of infection and lower patient burden, the interviews were conducted by FM and SM via telephone. The phone interviews took place between August and December 2021. The interviews were recorded and transcribed verbatim.

The interview data was analyzed based on Kuckartz's structured qualitative content analysis [30] supported by MAXQDA software (Verbi GmbH). Codes and categories were developed inductively, and were then incorporated into the data-driven development of the coding tree (Supplemental Material 3). For interviews with patients and HCP, slightly distinct codes were used to reflect different emphases in the interviews between the participant groups. For instance, patient interviews focused on the self-sampling experiences and patients' perception on its utility, whereas the main focus of HCP interviews was on transfer to standard rheumatology care. To ensure traceability, the coding tree and its application were validated through a member check with interview partners, which involved discussions of the coding tree and coded segments with two patients (Patient 2 & Patient 7) and two HCPs (HCP 1 & HCP 3). Data collection and analysis were performed circular by two researchers (FM, SM). Data collection continued until no substantially new findings emerged and meaning saturation was reached. Meaning saturation was defined as the state when no further dimensions, nuances, or insights can be found on a topic [31]. Finally, the two researchers (FM, SM) independently applied the coding tree to the entire material. Applied codes were exchanged and compared, and inconsistencies were resolved. This manuscript has been compiled in accordance with the Consolidated Criteria for Reporting Qualitative Research (COREQ) (Supplemental Material 4) [32]. For the presentation of the results, representative quotes of the transcripts were selected, translated into English and included into tables (Tables 23 and 4).

Results

Participant characteristics

From August to December 2021, we conducted a qualitative interview study on self-sampling of capillary blood with patients (n = 15) and HCP (n = 5). Mean age of interviewed patients (Table 1) was 56 years (range: 33–73). Eight patients used the TAP-II device and seven patients the Tasso + device. Most interviewed patients were female (14/15; 93%). Interviewed patients suffered from a variety of SRD, including rare disease, with systemic lupus erythematosus being the most frequent diagnosis (n = 6). Patients received their diagnosis a mean of 10 years ago (range: 1–34). Patients reported diverse occupational backgrounds. Mean duration of the patient interviews was 17 min (range:10–25). Mean HCP age was 28 years (range: 23–34). Three interview partners were men, two women. All interviewed HCP were entry level doctors (n = 3) or medical students (n = 2). Mean professional experience of the HCP was 2 years (range: 1–6). Mean duration of the HCP interviews was 19 min (range: 10–29).

Table 1 Sample Description

Feasibility

Patients were asked to describe their self-sampling experiences and their perception on its utility (Table 2). Overall, most patients reported easy application and high usability, with particular emphasis on the low volume of blood required and the absence of pain. The smooth application was also associated with the clear instructions provided by the study team, including an instruction video and written instructions. Although predominantly positive experiences were reported, interviewees mentioned limitations and negative experiences: Three patients reported adverse consequences of self-sampling. These were persisting wounds and hemorrhage. A recurring aspect reported by patients was the lack of sustainability of self-sampling and the high level of packaging waste associated with the sampling kits. Besides, patients reported that pressing the button to initiate the blood draw as well as removing the device and closing the collection tube were rather challenging tasks, especially with certain co-morbidities and low finger strength. One interviewee was concerned that uncontrolled transport might affect sample quality and test validity. The users' reports did not reveal any differences in feasibility between the two investigated self-sampling devices (Tasso + / TAP II).

Table 2 Feasibility

Transfer to standard rheumatology care

Another objective of the present study was to evaluate the perspectives of patients and HCPs on the implementation of capillary blood self-sampling in standard rheumatology care. Below, we present results regarding potential benefits and drawbacks (Fig. 2) as well as necessary requirements for implementation in standard rheumatology care (Table 3).

Fig. 2
figure 2

Main benefits and drawbacks of blood self-sampling

Table 3 Transfer to standard rheumatology care

Major potential benefits of implementing capillary blood self-sampling in standard rheumatology care reported by patients are time- and cost-savings. Self-sampling enables more insightful face-to-face consultations, as blood results are already available, and at the same time can lead to a reduction in overall hospital visits, which was perceived as a major benefit. Furthermore, reduced travelling costs and time were mentioned as advantages of self-sampling by patients and HCP alike. Concomitantly self-sampling could contribute to a better reconciliation of illness and work. Moreover, a reduced risk of infection by interviewees associated with self-sampling compared to blood collection in the hospital was reported as a benefit. The lower volumes of blood that the devices withdraw, easier collection of blood in patients who usually require multiple attempts with venous blood collection and less pain sensation during blood collection could result in less fear associated with blood collection. Patients and HCPs agreed that self-sampling might also help to better interpret new symptoms and decide if a face-to-face visit is necessary. The reduction of routine in-house appointments for patients who are in disease remission could ease the patient pathway and improve healthcare delivery and thus, might result in more efficient rheumatologic care. Additionally, self-sampling could also help to accelerate diagnosis and improve early detection of disease flares. Overall, HCPs and patients described similar benefits.

A substantial drawback inherent to the devices is the single-use status and relatively small blood volume, potentially limiting the number of laboratory tests and biomarker insights or requiring the use of specific analyzers that utilize blood volumes more effectively. Other drawbacks reported by HCPs and patients alike included the high level of adherence needed by patients to implement self-sampling correctly, connected to risk of bias and manipulation. As described in the "Feasibility" section, both patients and HCPs reported the extensive packaging and single-use of the sampling kits, resulting in a lot of waste, compared to standard blood collection. Furthermore, current low availability of sampling kits and high device costs were mentioned by HCPs as drawbacks. The aspects were opposed by one HCP (HCP 3: 06:45). In addition, few patients reported that it would be easier for them to visit the primary care practice to have blood drawn than to perform self-sampling at home.

The interviewees were asked about necessary requirements for the implementation of self-sampling in standard rheumatology care. A central need expressed by HCPs as well as patients was the possibility for patients to discuss self-sampling results with HCPs. Interviewed HCPs emphasized the importance of involving primary care physicians into self-sampling process. Finally, a thorough assessment was emphasized to determine which patients and which conditions are appropriate for self-sampling.

Potential user groups

Overall, interviewees considered the majority of rheumatic patients being eligible and able to perform self-sampling (Table 4). Diseases with an established serological biomarker for disease monitoring appear favorable for self-sampling, such as CRP for arthritis patients or anti-dsDNA antibodies for SLE patients. Furthermore, self-sampling could be offered to patients with difficulties accessing medical care, e.g. in rural areas or immobile patients. Potential users should show a high level of adherence, openness for self-management and willingness to independently draw blood. Furthermore, self-sampling might be particularly suitable for patients who are afraid of needles or where a traditional venous blood collection is difficult to carry out. In contrast, patients with temporarily or permanently reduced functional status (i.e. low finger strength, pain) might not be able to successfully collect blood. Furthermore, patients under anticoagulant therapy can be faced with prolonged bleeding. Younger patients were primarily considered to be better suited by patients and HCPs, as they were attributed to generally have less time compared to older patients that do not work anymore and enjoy spending time with their general physician. Yet, age as a criterion for exclusion was questioned by HCPs, as older patients with poor access to venous blood collection sites might also benefit from self-sampling of capillary blood.

Table 4 Potential user groups

Discussion

This qualitative study reports on SRD-patients' and HCPs' experiences and preferences regarding at-home capillary blood self-sampling in rheumatology care. Easy application and high usability were reported. Yet, adverse outcomes and challenges were also expressed, such as poor wound healing and prolonged bleeding. Patients and HCPs alike reported various potential benefits such as time savings, acceleration of disease management, increased independence and flexibility for the patient, which leads to improved reconciliation of disease and work, as well as reduced risk of infection with respiratory diseases during hospital and in-office visits particularly important for immunosuppressed patients. Reported drawbacks of self-sampling are the limited blood volume, ecological footprint, need for certain strength and motoric hand functions, respectively, to activate the lancet. Self-sampling is certainly not a solution that is an appropriate option for all patients and should therefore not aim to replace venous blood collection.

Suitability of self-sampling for the individual patient should be checked by HCPs and openly discussed with patients. Additionally, patients should have direct access to the laboratory results and the opportunity to discuss these with their treating physician. Optimally, the laboratory results from at-home self-sampling and consecutive virtual appointments can guide disease management, including the need for face-to-face visits and treatment changes.

Our results are in line with findings on self-sampling concepts from other medical domains: In diabetes management, self-collection of blood has been extensively studied [33]. Additionally, there is also evidence that self-swabs in screening for sexually transmitted infections are useful tools that support the diagnosis of human papilloma virus [34]. The acceptance of self-sampling was further accelerated due to extensive testing for SARS-CoV 2 infections during the COVID-19 pandemic that was often performed by the patient or at a remote point of care [35], which allows patients easier access to testing and reduces infection risk [36]. Plus, self-collection of specimens for SARS-CoV-2 testing, preparation and shipment of specimens for analysis are well accepted [37].

Our results indicate that, according to users, self-sampling might represent a useful addition to remote rheumatology care for certain patients. Thus, our qualitative data confirm the survey results of Kernder et al. that depicted the willingness of rheumatologists and rheumatic patients to incorporate self-sampling into routine care [9, 38]. However, as in other medical domains, patient empowerment and opportunities for consultation with health care professionals are essential prerequisites for scaling self-sampling to the “new norm” in rheumatology care [39]. Similar to the implementation of telehealth technologies [40], careful consideration must be given in advance to which form of blood collection is appropriate for which patients, in which situation. Thus, we compiled a brief checklist that may guide HCPs in the first assessment of patient suitability (Table 5).

Table 5 Checklist for assessing appropriateness of self-sampling

In line with the recent increase of telemedicine usage in rheumatology [9, 41, 42], interviewees acknowledged the potential of self-sampling to enhance current rheumatology remote care, improving accessibility and unlocking resources [43]. Remote self-monitoring, using electronic patient reported outcomes (ePROs), in conjunction with laboratory calprotectin test results that were based on self-collected stool samples improved the management of patients with inflammatory bowel disease [44, 45]. De Thurah et al. could demonstrate that CRP testing together with ePRO-based telehealth follow-up strategy, achieve similar disease control as conventional outpatient follow up, while reducing the number of rheumatologist visits at the same time [18]. Similarly, we are currently investigating the potential of ePROS in combination with semi-quantitative CRP results from point of care in RA [46] and the TAP II devices for precise CRP measurement in patients with spondyloarthritis. In terms of diagnosis, self-sampling could improve the currently limited accuracy of very popular symptom-checkers through consideration of objective laboratory results [47, 48].

Self-sampling might not only have clinical—but also environmental, social and economic impact: Interviewees living in rural areas described that they have to take a whole day off work to visit the hospital for standard venous blood sampling, which results in productivity losses [49] and indirect medical costs [50]. Self-sampling could contribute to a better compatibility of illness and work. Moreover, according to a recent WHO report, the Covid-19 pandemic has led to a massive increase in health care waste [51]. Part of this waste are single-use test kits and personal protective equipment. The results of our study suggest the rising environmental awareness in medical care. Patients criticized the large amount of waste associated with self-sampling and the fact that trialed test kits are single use only. This was contrasted by one interviewee, who indicated that the medical waste would be generated in standard blood-sampling as well, except that the waste remains in the medical institution and is therefore less visible to patients. Nevertheless, self-sampling could reduce the need for personal protective equipment [51] and emissions for trips to the hospital.

To our knowledge, this is the first qualitative study on patients’ and care providers’ perspectives on at-home self-sampling in rheumatology. The qualitative study design allowed for an in-depth description of the participants’ perceptions. Due to the open and exploratory approach patients and HCPs were able to state miscellaneous benefits and drawbacks of self-sampling, as well as their ideas regarding transferability to clinical routine. However, there are certain limitations to the qualitative design of this study. As the 20 interviews do not allow any conclusions regarding the success rate, usability and acceptance of the two trialed devices. These areas require further research, respectively were analyzed separately based on quantitative data [28]. Furthermore, statements of the included participants from a single study site may not be representative, as only patients with some rheumatic diseases and largely female (93%) were included. In addition, only physicians and medical students were included. Interviews with other HCP groups, such as rheumatology nurses, would have contributed to a more comprehensive picture regarding the transferability of blood self-sampling to standard care. The interviewed HCPs were very young, with limited work experience at a university hospital. We nevertheless chose to interview medical students because they supervised the blood self-sampling procedure in this and another study [52]. Recall bias cannot be excluded due to a time difference between self-sampling and the interview. In addition, results may be biased toward the benefits of self-sampling as participants agreed to participate in the study and HCPs were involved in the conduction of the study.

Conclusion

Self-sampling could be a valuable addition to remote rheumatology care, promising more convenience to patients and improved efficiency of scarce rheumatology services. Limited blood volume, required patients’ adherence and lack of sustainability represent current drawbacks. Individual patient assessment is required to determine the likelihood of successful adoption and extent of the benefit.

Availability of data and materials

All data relevant to the study are included in the article or uploaded as supplementary information. For further questions regarding the reuse of data, please contact the corresponding author (felix.muehlensiepen@mhb-fontane.de).

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Acknowledgements

The authors thank all patients, partners and collaborators for their support of this project. This study is part of the PhD thesis of FM (AGEIS, Université Grenoble Alpes, Grenoble, France).

Funding

Open Access funding enabled and organized by Projekt DEAL. The study was supported by the Deutsche Forschungsgemeinschaft (DFG, project “PANDORA”), Thermo Fisher Scientific (Freiburg, Germany), the Bundesministerium für Bildung und Forschung (BMBF; project “MASCARA”) and the Innovative Medicine Initiative (project “Hippocrates”).

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Authors and Affiliations

Authors

Contributions

All authors were involved in drafting the article and critically revising it for important intellectual content, and all authors approved the final version to be submitted for publication. FM had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study conception and design. FM, JK, EV, GB, MK, CE-A. Acquisition of data. FM, SM, JK, JZ, SB, HL. Analysis and interpretation of data. FM, JK, SM, KB, MH, NV, GS, GK.

Corresponding author

Correspondence to Felix Muehlensiepen.

Ethics declarations

Ethics approval and consent to participate

All participants provided written informed consent prior to participating in the study. The study was conducted in accordance with the 1964 Helsinki declaration and its later amendments and was approved by the ethics authorities of Friedrich-Alexander University Erlangen-Nürnberg and Universitätsklinikum Erlangen (Reg no. 320_20B). Data collection and analysis were carried out according to quality criteria of the working group Qualitative Methods in the German Network for Health Services Research e.V. This manuscript has been compiled in accordance with the Consolidated Criteria for Reporting Qualitative Research.

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Not required.

Competing interests

None declared.

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Supplementary Information

Additional file 1: 

Supplemental Material 1. Interview Guide – Patient.

Additional file 2: 

Supplemental Material 2. Interview Guide – HCP.

Additional file 3: 

Supplemental Material 3. Coding Tree.

Additional file 4.

COREQ (COnsolidated criteria for REporting Qualitative research) Checklist.

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Muehlensiepen, F., May, S., Zarbl, J. et al. At-home blood self-sampling in rheumatology: a qualitative study with patients and health care professionals. BMC Health Serv Res 22, 1470 (2022). https://doi.org/10.1186/s12913-022-08787-5

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Keywords

  • Blood self-sampling
  • Rheumatology
  • User experience
  • Remote Care
  • Qualitative Research
  • Telemedicine