Health Technology Research Articles

Lower urinary tract symptoms in men after surgery for benign prostatic hyperplasia

BACKGROUND: The development of medical technologies has resulted into a significant increase in the number of patients undergoing minimally invasive surgeries for benign prostatic hyperplasia. However, 29.9–41% of patients after surgical treatment are not satisfied with the surgical treatment results. AIM: To assess the rate and nature of lower urinary tract symptoms in men after surgical treatment of benign prostatic hyperplasia with various surgical techniques. MATERIALS AND METHODS: A telephone survey was carried out among 6117 men aged 59.57 ± 11.11 years (48–83 years), who underwent surgical treatment for benign prostatic hyperplasia with various surgical techniques and 5960 of these patients were surveyed using the IPSS questionnaire in the period 2012–2022. Moreover, to assess urination, patients kept their voiding diaries for 72 hours, a questionnaire to evaluate the symptoms of overactive bladder; ultrasound of the bladder, prostate and upper urinary tract, uroflowmetry, and, if indicated, a urodynamic study were performed. RESULTS: The study showed that 2413 (40.5%) patients were “absolutely satisfied” with the surgical treatment results, 829 (13.9%) patients were “partially satisfied” and noted improved urination, although its quality was assessed as unsatisfactory, and 2718 (45.6%) operated men were “absolutely dissatisfied”. Lower urinary tract symptoms persisted in 2655 (47.9%) men which underwent surgery, and in 3.3% of cases (87 patients) their severity increased in the postoperative period. CONCLUSIONS: The high rate of dissatisfaction with the surgical treatment results of patients with benign prostatic hyperplasia is caused by the persistence of irritative symptoms in the postoperative period and does not depend on the surgery performed. The origin of symptoms in most patients is not associated with benign prostatic hyperplasia, and the surgery indications are overestimated.

Combined laparoscopic nephroureterectomy with transurethral approach to the ureter in renal tuberculosis treatment

BACKGROUND: Tuberculosis of the genitourinary system is a common cause of organ removal surgeries. Despite the improvement of medical technologies, kidney and urinary tract surgeries for urogenital tuberculosis are traditionally performed using the open method. AIM: To assess the findings of laparoscopic and open combined nephroureterectomy with transurethral resection of the distal ureter in patients with renal tuberculosis. MATERIALS AND METHODS: The findings of 61 nephroureterectomies with transurethral resection of the distal ureter performed for destructive renal tuberculosis were analyzed. Open nephroureterectomy was performed in 31 patients, and laparoscopic approach was used in 30 patients. Patients in both groups were comparable by gender and age. RESULTS: The surgery duration, volume of intraoperative blood loss, rate and severity of postoperative complications were lower in patients who had laparoscopic interventions. When examined 1 month after surgery, patients in both groups showed the improvement of clinical parameters. The following changes were reported: a significant decrease in the nighttime urination rate, a decrease in IPSS scores, and an increase in the functional bladder capacity without significant differences depending on the surgical approach. After the surgery, a significant improvement in the quality of patients’ life was observed. In patients who had laparoscopic surgery, improvements were detected in all the SF-36 questionnaire domains. However, in patients after open surgery with a positive effect on most of assessed parameters no significant improvement of parameters in section “General Physical Health” was found. CONCLUSIONS: Irrespective of the selected approach, combined nephroureterectomy with transurethral resection of the distal ureter is an effective method of surgical treatment of patients with destructive renal tuberculosis. Moreover, the laparoscopic technique has shown a number of significant advantages over open surgery.

Advanced treatment-resistant ovarian germ cell tumor (yolk sac tumor) with successful fertility realization 20 years after combined treatment: a case report

Background. Yolk sac tumors (YST) are classified as rare malignant germ cell tumors of the ovaries, most commonly found in young patients interested in preserving fertility. YST is characterized by large size, predominantly unilateral involvement, and increased production of alpha-fetoprotein, which can be used as an important diagnostic criterion for this condition. Among all germ cell tumors, YST has the least favorable prognosis. The primary goals of YST treatment are not only to improve prognosis and quality of life but also to enable the patient to fulfill her reproductive plans in the future.Description of the clinical case. We present a clinical case of an aggressive course of yolk sac tumor in the ovary of a 15-year-old girl, requiring multiple surgeries, repeated courses of high-dose drug therapy, and bone marrow transplantation.Conclusion. This is a rare case of YST with successful preservation of reproductive function due to modern medical technologies despite aggressive treatment.

Motorized spiral enteroscopy: A cautious step forward in technological innovation

With the continuous advancement in medical technology, endoscopy has gained significant attention as a crucial diagnostic tool. The introduction of motorized spiral enteroscopy (MSE) represents a significant advancement in the diagnosis and treatment of small bowel diseases. While there are safety concerns and a high reliance on the operator’s skills, MSE should not be disregarded entirely. Instead, it should be considered as a supplementary endoscopic technique, particularly in situations where conventional endoscopy proves ineffective. Through continuous research and technical optimization, MSE has the potential to become an important addition to the endoscopy toolbox in the future. We call on colleagues in the industry to work together to promote the improvement of MSE technology through continuous research and practice, with the aim to bring out its unique value in endoscopy while ensuring patient safety.

Clinical features and risk factors of Klebsiella pneumoniae infection in premature infants: a retrospective cohort study.

With the continuous advancement of modern medical technology, the survival rate of premature infants has significantly increased. Klebsiella pneumoniae (K. pneumoniae) is one of the most common pathogens causing neonatal infections, particularly posing a serious risk to premature infants. This study aimed to analyze the clinical characteristics, antibiotic susceptibility profiles, and treatment outcomes of K. pneumoniae infections in these infants. We retrospectively compared cases of K. pneumoniae infection in premature and term infants admitted in a tertiary hospital from January 2017 to December 2022 in China. Clinical and microbiological characteristics were evaluated. Data analysis was performed using the Statistical Package for the Social Sciences (SPSS), with statistical significance defined as P < 0.05. We enrolled 166 premature infants and 68 term infants. In premature infants, fetal distress, patent ductus arteriosus, patent foramen ovale, enteritis, anemia, hypoproteinemia, bloodstream infections, abdominal infection, mechanical ventilation, nasogastric feeding, drainage tube, parenteral nutrition, and prior exposure to carbapenem antibiotics were identified as significant risk factors for K. pneumoniae infections in univariate analysis. Furthermore, septic shock, bloodstream infections, abdominal infections, indwelling catheters, drainage tubes, parenteral nutrition, and previous exposure to glycopeptide antibiotics were significantly correlated with mortality. Independent risk factors for K. pneumoniae infections in premature infants included fetal distress (OR: 3.702, [95% CI: 1.056-12.986], P = 0.041), enteritis (OR: 4.434, [95% CI: 1.066-18.451], P = 0.041), anemia (OR: 4.028, [95% CI: 1.550-10.466], P = 0.004), bloodstream infections (OR: 1.221, [95% CI: 0.061-1.802], P = 0.022), mechanical ventilation (OR: 4.974, [95% CI: 1.685-14.685], P = 0.004) and prior exposure to carbapenem antibiotic (OR: 14.738, [95% CI: 2.393-90.767], P = 0.004). Additionally, abdominal infections (OR: 8.598, [95% CI: 2.000-36.957], P = 0.004) and indwelling catheters (OR: 7.698, [95% CI: 0.998-59.370], P = 0.050) were positive predictors of mortality. K. pneumoniae isolates exhibit a notable prevalence of infection, poor treatment outcomes, and elevated resistance in preterm neonates. These findings enhance our understanding of K. pneumoniae infections and their association with clinical outcomes among premature infants.

Erratum for The Effectiveness of Spiritual Competence Training on the Psychological Well-being of Preschool Teachers. Health Technology Assessment in Action [Health Tech Asmnt Act. 2023; 6(2)

The Article Abstract is not available

Erratum for Evaluation of Validity Indices of Spiritual Competence Questionnaire. Health Technology Assessment in Action [Health Tech Asmnt Act. 2021; 5(1)

The Article Abstract is not available

Retrospective study on clinical value and optimal use of [18F] FDG PET/CT for inflammation of unknown origin in Japanese patients.

Despite advancements in medical technology, the challenges of diagnosing fever of unknown origin (FUO) and inflammation of unknown origin (IUO) persist. Positron emission tomography/computed tomography (PET/CT) has been used to assess these conditions; however, it is unclear which patients most benefit from this approach. This study aimed to assess the clinical value and optimal use of fluorine-18-labelled-fluorodeoxyglucose (18F-FDG)-PET/CT in patients with FUO/IUO. We reviewed FDG-PET/CT scans conducted at our department between January 2014 and December 2020 to further assess FUO/IUO. FUO was defined as a fever lasting over three weeks without a diagnosis based on conventional assessment. IUO was defined as prolonged inflammation with a body temperature below 38.3 ℃ and without a diagnosis after conventional diagnostic procedures. The efficacy of FDG-PET/CT was determined based on the diagnostic outcomes achieved by integrating imaging findings with histopathological or microbiological evidence, clinical criteria, or follow-up assessments. We conducted crude and age-sex adjusted logistic regression for potential risk factors to determine the degree of burden on demographic and clinical characteristics. Forty-five patients with FUO/IUO underwent FDG-PET/CT, and final diagnoses were made in 32 patients (71.1%). The percentages of diagnostic categories were 53.3%, 8.9%, and 6.7% for non-infectious inflammatory diseases, malignancy, and infection, respectively. In multivariable logistic regression analysis, IUO was the only independent predictor of the efficacy of FDG-PET/CT in the final diagnosis (odds ratio, 67.02; 95% confidence interval, 4.02-1119). Our results indicate that IUO was associated with a higher diagnostic yield compared to those with FUO.

Factors Associated with the Practice of Assessing Drug–Drug Interactions Among Pharmacists in Saudi Arabia

Background: Drug–drug interactions (DDIs) occur when two or more drugs are administered concomitantly, changing the pharmacokinetics or pharmacodynamics of a drug’s characteristics. Despite the advances in health technology, DDIs remain a concern to patient safety. This study aimed to (1) assess the knowledge, attitude, and practice of hospital and community pharmacists toward DDIs in Saudi Arabia and (2) examine factors associated with their practice. Methods: A cross-sectional study was conducted using an online self-administered questionnaire targeting hospital and community pharmacists working in Saudi Arabia. The study questionnaire consisted of five sections: demographics, knowledge, attitude, and practice toward DDIs, as well as pharmacy characteristics. Descriptive statistics were used to summarize the characteristics of participants as count and percentage. Chi-square tests were used to examine associations between practice variables and other independent variables. Results: A total of 131 pharmacists participated in the study. The majority were males (81.7%), aged 26–35 years (64.9%), and worked in community pharmacies (81.7%). Nearly half of the participants reported optimal practice regarding checking drug interactions before dispensing any drug. Factors associated with the practice of checking DDIs were found to be gender, perceived workload, perceived knowledge, and attitude variables. Regarding the practice of asking patients about their prescription and OTC drugs, there were statistically significant differences between hospital and community pharmacists. Conclusions: Our findings on both community and hospital pharmacists in Saudi Arabia reveal that pharmacists’ attitudes and perceived knowledge might influence the practice of pharmacists toward DDIs.

Using Compressed JPEG and JPEG2000 Medical Images in Deep Learning: A Review

Machine Learning (ML), particularly Deep Learning (DL), has become increasingly integral to medical imaging, significantly enhancing diagnostic processes and treatment planning. By leveraging extensive datasets and advanced algorithms, ML models can analyze medical images with exceptional precision. However, their effectiveness depends on large datasets, which require extended training times for accurate predictions. With the rapid increase in data volume due to advancements in medical imaging technology, managing the data has become increasingly challenging. Consequently, irreversible compression of medical images has become essential for efficiently handling the substantial volume of data. Extensive research has established recommended compression ratios tailored to specific anatomies and imaging modalities, and these guidelines have been widely endorsed by government bodies and professional organizations globally. This work investigates the effects of irreversible compression on DL models by reviewing the relevant literature. It is crucial to understand how DL models respond to image compression degradations, particularly those introduced by JPEG and JPEG2000—both of which are the only permissible irreversible compression techniques in the most commonly used medical image format—the Digital Imaging and Communications in Medicine (DICOM) standard. This study provides insights into how DL models react to such degradations, focusing on the loss of high-frequency content and its implications for diagnostic interpretation. The findings suggest that while existing studies offer valuable insights, future research should systematically explore varying compression levels based on modality and anatomy, and consider developing strategies for integrating compressed images into DL model training for medical image analysis.

Human Factors, Human-Centered Design, and Usability of Sensor-Based Digital Health Technologies: Scoping Review.

Increasing adoption of sensor-based digital health technologies (sDHTs) in recent years has cast light on the many challenges in implementing these tools into clinical trials and patient care at scale across diverse patient populations; however, the methodological approaches taken toward sDHT usability evaluation have varied markedly. This review aims to explore the current landscape of studies reporting data related to sDHT human factors, human-centered design, and usability, to inform our concurrent work on developing an evaluation framework for sDHT usability. We conducted a scoping review of studies published between 2013 and 2023 and indexed in PubMed, in which data related to sDHT human factors, human-centered design, and usability were reported. Following a systematic screening process, we extracted the study design, participant sample, the sDHT or sDHTs used, the methods of data capture, and the types of usability-related data captured. Our literature search returned 442 papers, of which 85 papers were found to be eligible and 83 papers were available for data extraction and not under embargo. In total, 164 sDHTs were evaluated; 141 (86%) sDHTs were wearable tools while the remaining 23 (14%) sDHTs were ambient tools. The majority of studies (55/83, 66%) reported summative evaluations of final-design sDHTs. Almost all studies (82/83, 99%) captured data from targeted end users, but only 18 (22%) out of 83 studies captured data from additional users such as care partners or clinicians. User satisfaction and ease of use were evaluated for 83% (136/164) and 91% (150/164) of sDHTs, respectively; however, learnability, efficiency, and memorability were reported for only 11 (7%), 4 (2%), and 2 (1%) out of 164 sDHTs, respectively. A total of 14 (9%) out of 164 sDHTs were evaluated according to the extent to which users were able to understand the clinical data or other information presented to them (understandability) or the actions or tasks they should complete in response (actionability). Notable gaps in reporting included the absence of a sample size rationale (reported for 21/83, 25% of all studies and 17/55, 31% of summative studies) and incomplete sociodemographic descriptive data (complete age, sex/gender, and race/ethnicity reported for 14/83, 17% of studies). Based on our findings, we suggest four actionable recommendations for future studies that will help to advance the implementation of sDHTs: (1) consider an in-depth assessment of technology usability beyond user satisfaction and ease of use, (2) expand recruitment to include important user groups such as clinicians and care partners, (3) report the rationale for key study design considerations including the sample size, and (4) provide rich descriptive statistics regarding the study sample to allow a complete understanding of generalizability to other patient populations and contexts of use.

Unravelling the Association Between Uncertainties in Model-based Economic Analysis and Funding Recommendations of Medicines in Australia.

Health technology assessment is used extensively by the Pharmaceutical Benefits Advisory Committee (PBAC) to inform medicine funding recommendations in Australia. The PBAC often does not recommend medicines due to uncertainties in economic modelling that result in delaying access to medicines for patients. The systematic identification of which uncertainties can be reduced with alternative evidence or the collection of additional data can help inform recommendations. This study aims to characterise different types of uncertainty in economic models and empirically assess their association with the PBAC recommendations. A framework was developed to characterise four types of uncertainties: methodological, structural, generalisability and parameter uncertainty. The first two types were further subcategorised into parameterisable and unparameterisable uncertainty. Data on uncertainty and other factors were extracted from PBAC's Public Summary Documents of first submissions for 193 medicine (vaccine)-indication pairs including economic modelling between 2014 and 2021. Logistic regression was used to estimate the average marginal effect of each type of uncertainty on the probability of a positive recommendation. The PBAC more often raised issues regarding parameter uncertainty (95%) and parameterisable structural uncertainty (83%) than generalisability uncertainty (48%) and unparameterisable methodological uncertainty (56%). The logistic regression results suggested that the PBAC was more likely to recommend a medicine without unparameterisable methodological, generalisability, and parameterisable structural uncertainty by 15.0%, 10.2 %, and 17.6%, respectively. Parameterisable methodological, unparameterisable structural and parameter uncertainty were not significantly associated with the PBAC recommendations. This study identified the uncertainties that had significant associations with PBAC recommendations based on the first submission. This may help improve model quality and reduce resubmissions in the future, thus improving patients' access to medicines.

A model for integrating palliative care into Eastern Mediterranean health systems with a primary care approach.

Palliative care in the Eastern Mediterranean Region (EMR) faces challenges despite the high number of patients in need. To provide accessible, affordable, and timely services, it is crucial to adopt a suitable care model. World health organization (WHO) recommends integrating palliative care with primary health care (PHC). Given the unique conditions of EMR countries, there is a need to design a model tailored to these contexts. This study is a multi-method research project conducted through several sub-studies, including a literature review, policy analysis, expert opinion (Delphi Method), dimension-specific analysis, model development, and its validation and refinement (Delphi Method). Drawing from the WHO model, six dimensions: policy, drug availability, education, community integration, service delivery, and research were considered to developing the model and implementation requirements. Within each dimension, evidence-based solutions tailored to the region's context were explored. A successful palliative care model requires, in the policy dimension, oversight by the Ministry of Health (MOH). Having a focal-person or working group within the MOH is crucial for policy-making, formulation, and approval of clinical guidelines, as well as addressing care challenges. It is essential to provide access to morphine and other essential medications, along with facilitating the administration and consumption of morphine at home. Conducting empowerment courses for care providers, can address various challenges. Community involvement through volunteers, charities, and non-governmental organizations (NGOs) is also important. To ensure service provision, monitoring and evaluating systems are crucial, along with striving for service continuity through an appropriate payment system. Lastly, research is necessary for needs assessment, evidence-based practice, and designing evaluation indicators. The proposed model relies on community health workers, especially nurses, as multitasking professionals available for community palliative care. In the presented model, special attention has been given to networking, collaboration, and the use of digital health technologies to support nurses. The model proposed for integrating palliative care into PHC should serve as a framework that enhances access to available and affordable services for countries in the region. While this model was developed based on the overall conditions of the region, each country can tailor it to its unique strengths and opportunities.

Personalized interventions for behaviour change: A scoping review of just-in-time adaptive interventions.

Examine the development, implementation and evaluation of just-in-time adaptive interventions (JITAIs) in behaviour change and evaluate the quality of intervention reporting. A scoping review of JITAIs incorporating mobile health (mHealth) technologies to improve health-related behaviours in adults. We searched MEDLINE, Embase and PsycINFO using terms related to JITAIs, mHealth, behaviour change and intervention methodology. Narrative analysis assessed theoretical foundations, real-time data capturing and processing methods, outcome evaluation and summarized JITAI efficacy. Quality of intervention reporting was assessed using the template for intervention description and replication (TIDieR) checklist. Sixty-two JITAIs across physical activity, sedentary behaviour, dietary behaviour, substance use, sexual behaviour, fluid intake, treatment adherence, social skills, gambling behaviour and self-management skills were included. The majority (71%) aimed to evaluate feasibility, acceptability and/or usability. Supporting evidence for JITAI development was identified in 46 studies, with 67% applying this to develop tailored intervention content. Over half (55%) relied solely on self-reported data for tailoring, and 13 studies used only passive monitoring data. While data processing methods were commonly reported, 44% did not specify their techniques. 89% of JITAI designs achieved full marks on the TIDieR checklist and provided sufficient details on JITAI components. Overall, JITAIs proved to be feasible, acceptable and user-friendly across behaviours and settings. Randomized trials showed tailored interventions were efficacious, though outcomes varied by behaviour. JITAIs offer a promising approach to developing personalized interventions, with their potential effects continuously growing. The recommended checklist emphasizes the importance of reporting transparency in establishing robust intervention designs.

Outcomes of guidelines from health technology assessment organizations in community-based primary care: a systematic mixed studies review.

Health technology assessment (HTA) organizations generate guidelines to inform healthcare practices toward improved health outcomes. This review sought to identify and classify outcomes of guidelines from HTA organizations within published research. We performed a systematic mixed studies review of empirical studies that (a) referred to a published guideline from an HTA organization and (b) reported an outcome resulting from a guideline. We searched the published literature in English or French within seven databases. Outcome types were classified within five dimensions of an existing framework for online health information (e.g., relevance, cognitive/affective impact, and use). Subdimensions were inductively developed. A two-phase sequential data synthesis was performed. Phase 1: a hybrid deductive-inductive thematic analysis identified the types of outcomes and displayed their relationships on a concept map. Phase 2: descriptive statistics were tabulated by the type of outcome. A total of 6,719 records were retrieved through searches on 6 February 2023. After screening, we included 120 observational studies (twenty-one qualitative, ninety-four quantitative, and five mixed methods). Phase 1 identified twenty-nine types of outcomes. The most frequently reported outcomes were within the organizational dimension (reported in ninety-four studies). The most common subdimensions were "Referrals" (thirty-eight occurrences), the "Quality of Prescriptions" (fifteen occurrences), and the "Quality of Diagnosis" (eight occurrences). For Phase 2, we could only generate descriptive statistics on seventeen outcomes. These were almost equally distributed among positive, neutral, and negative effects. Our results contribute to knowledge about the outcomes of HTA guidelines and options for documenting and measuring them in future evaluations.

Using digital health technologies to optimise antimicrobial use globally.

Digital health technology (DHT) describes tools and devices that generate or process health data. The application of DHTs could improve the diagnosis, treatment, and surveillance of bacterial infection and the prevention of antimicrobial resistance (AMR). DHTs to optimise antimicrobial use are rapidly being developed. To support the global adoption of DHTs and the opportunities offered to optimise antimicrobial use consensus is needed on what data are required to support antimicrobial decision making. This Series paper will explore bacterial AMR in humans and the need to optimise antimicrobial use in response to this global threat. It will also describe state-of-the-art DHTs to optimise antimicrobial prescribing in high-income and low-income and middle-income countries, and consider what fundamental data are ideally required for and from such technologies to support optimised antimicrobial use.

Advancing the management of maternal, fetal, and neonatal infection through harnessing digital health innovations.

Infections occurring in the mother and neonate exert a substantial health burden worldwide. Optimising infection management is crucial for improving individual outcomes and reducing the incidence of antimicrobial resistance. Digital health technologies, through their accessibility and scalability, hold promise in improving the quality of care across diverse health-care settings. In settings with poor access to laboratory services, innovative uses of existing data, point-of-care diagnostics, and wearables could allow for better recognition of host responses during infection and antimicrobial optimisation. The linkage and connectivity of information can support the coordinated delivery of care between health-care facilities and the community. Continuous real-time monitoring of infection markers in the mother and neonate through biosensing can provide notable opportunities for intervention and improvements in care. However, the development and implementation of these interventions should be respectful, prioritise safety, and emphasise sustainable, locally derived solutions. Addressing existing gender, economic, and health-care disparities will be essential for ensuring equitable implementation.

Challenges associated with access to recently developed hemophilia treatments in routine care: perspectives of healthcare professionals.

The treatment landscape for haemophilia continues to rapidly develop, and expectations for future treatment success are high. There is limited information on the challenges to accessing new and innovative therapies. The aim of this study was to explore challenges with accessing haemophilia treatment from the perspective of healthcare professionals (HCPs). A crosssectional study design was used. A pilot-tested, online survey was distributed to haemophilia treatment centres in Australia, Canada, France, Italy, New Zealand, Republic of Ireland, Turkey, the United States, and the United Kingdom. The questionnaire covered questions on product access, economic considerations, health technology assessment requirements, and patient organization involvement. The results were analyzed descriptively using SPSS. A total of 154 HCPs completed the questionnaire. There was heterogeneity across countries, regions, and centres regarding HCPs' knowledge of access to novel recently developed treatments. Notable limitations to access were reported such as differences in access based on age of patient and type of product, economic considerations, and the growing influence of HTA bodies. Many countries have a hemophilia patient organization that does not have a vote at the decision-making table. There is a need to empower HCPs to better understand national healthcare structures and decisions that lead to access limitations. Requirements from HTA bodies must be understood to optimally design clinical studies and value generation of treatment options. This may strengthen the haemophilia treatment centre's voice to collectively mandate for exchange with key involved individuals, such as the payers and politicians for the provision of optimal therapy.

Patient-Generated Data as Interventions in Doctor-Patient Relationships? Negotiating (Un)Invited Participation in Medical Consultations.

Health data generated by apps and devices are increasingly popular and expected to affect various aspects of doctor-patient relationships. No longer confined to medically authorised and certified health technologies, a range of biomedical data-from heart rate to blood pressure or oxygen saturation-are captured and processed by consumer health devices. This article outlines different responses of physicians to patients collecting data with popular consumer devices and considers how the data may challenge or reify medical authority. Based on semi-structured interviews with doctors and chronically ill patients in Germany from 2021 to 2023, we compare cases from diabetes, sleep disorders, cardiovascular conditions, obesity and ME/CFS and explore when, how and for what reasons different medical specialists consider patient-generated data (PGD) from consumer devices in outpatient settings. Their response registers vary: whereas some physicians reject PGD that seem to compete with their diagnostic activities, others tolerate the data (collection), whereas still others more readily include them into their diagnostic practices. This suggests nuanced strategies for navigating the demarcation between accepting or rejecting 'uninvited' participation through PGD from consumer apps and devices.

Essential strategic principles for planning and developing digitally enabled interventions in health and care settings.

Health and care information technologies can improve service delivery, but unfortunately many fail to realise their potential. This is because tools fail to effectively integrate with user and organisational practices. We here draw on two decades and an extensive body of practical and theoretical experience of conducting formative evaluations in health service settings to extract seven essential principles for planning and developing digital tools. Firstly, it is important to determine if digitalisation is the right approach for the desired change and to view these tools as complex interventions needing careful planning. The development process should embrace varying levels of co-creation and adapt to different needs and contexts. Ensuring that tools integrate well with existing information infrastructures and striking a balance between being widely applicable and locally relevant is essential. Furthermore, planning for how these interventions will fit into broader health and care pathways is vital. By considering these factors, decision-makers can significantly improve the chances of successful implementation, adoption and scaling of health and care technologies.