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Suicide poses a severe public health challenge worldwide, impacting individuals, families, work, and society. The multifaceted nature of suicide demands a complex approach involving psychological, biological, social, cultural, and environmental factors. Recognizing suicide’s status as the leading external cause of death in Spain, prevention increasingly incorporates technology, specifically mobile and software applications.
Methods
A systematic review of the effectiveness and safety of mobile and software applications was conducted (MEDLINE, Embase, CINAHL, and PsycINFO databases). Outcome variables included: suicide; suicidal behavior; suicidal intent; suicidal ideation/thinking; self-perceived suicide risk; using/seeking mental health services; associated mental symptoms; mental health-related quality of life; satisfaction of the user and the health professional; adverse events related to the app, as defined in the included studies. Studies that do not include suicidal behavior, intention, or ideation were excluded. Where available data allowed, a meta-analysis was conducted for each outcome variable.
Results
One systematic review and 13 randomized controlled trials (n=2,952) were analyzed. No significant differences were found in deaths by suicide or suicide attempts. At post-intervention, small but significant reductions were observed in suicidal ideation, hopelessness, depression, and worry, with anxiety reduction slightly above statistical significance. At follow-up (8 to 52 weeks), these variables also obtained significant results, except depression and suicidal ideation. Regarding safety, there was no significant difference in safety phone calls for participants with suicidal ideation.
Conclusions
The evidence on suicide prevention app effectiveness is of low quality, precluding conclusive findings. Attempt reduction is suggested at 21 percent, but the confidence interval includes a potential 60 percent increase. Evidence on suicide-related psychological variables (suicide ideation, depression, hopelessness, and anxiety) is of higher quality (low–moderate), but effects are small and clinically uncertain. Safety findings are uncertain, impacting risk/benefit balance.
Chronic kidney disease (CKD) is a progressively worsening condition that is often overlooked in its early stages. In Brazil, factors such as population aging and rising comorbidities are expected to shift CKD prevalence toward more advanced stages, leading to greater socioeconomic and environmental impacts. The significant burden of renal replacement therapy (RRT) suggests the need to prioritize preventive and early detection strategies.
Methods
We developed a patient-level simulation model to estimate the impact of CKD in Brazil over 10 years (from 2023 to 2032) on clinical, patient, health system, environmental, productivity, and societal outcomes. Validation was conducted against Brazilian demographic data and cross-validated with the Inside CKD model. We estimated productivity losses by multiplying CKD-related workdays missed by daily costs for patients and caregivers.
Results
The number of Brazilians with CKD was projected to increase by 7.2 percent (approximately 27.7 million) over the next 10 years, mainly among patients with late-stage disease, while the number of patients undergoing dialysis was projected to increase by 170.8 percent (approximately 233,000) over the same period. CKD was projected to result in BRL198 billion (USD 38 billion) of lost income. From an environmental standpoint, freshwater consumption, fossil fuel depletion, and carbon dioxide emissions due to patients with CKD were projected to increase by 40 percent by 2032. RRT was projected to require the equivalent annual water usage of approximately 370,000 households and the annual power of approximately 11 million lightbulbs and will produce annual carbon dioxide emissions equivalent to approximately 1.5 million cars.
Conclusions
While the overall number of patients with CKD will increase by 7 percent (from 25.8 million in 2022 to 27.7 million in 2032), the distribution toward later stages of CKD will cause significant impacts in terms of the healthcare system (resource use and costs), patients and caregivers, society, and the environment.
Patient engagement in the health technology assessment (HTA) field is crucial but faces significant challenges. This study focuses on identifying the barriers and facilitators surrounding the incorporation of patients in HTA while proposing solutions from the perspective of the Patient Interest Group (GIP) within the Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS).
Methods
An ad hoc questionnaire with four open-ended questions about barriers, facilitators, and proposals was developed and distributed among the GIP members through an email survey methodology. The obtained results were discussed in an open in-person meeting, and a thematic analysis of the data was conducted.
Results
Fifteen people answered the questionnaire (at least one HTA researcher from each agency), and forty people participated in the face-to-face discussion. Main barriers included the perception of a lack of institutional support, insufficient participative culture, lack of time and experience, and difficulties in planning. Facilitators included activities organized within the GIP and methodological procedures and documents published. The main proposals for improvement were focused on the training and capacity building of HTA researchers and patients, institutional commitment to patient involvement, promotion of forums and activities with patient entities, and improvement of communication channels with patients and dissemination.
Conclusions
Despite current challenges in patient involvement, this study highlights facilitators and proposals for improvement. Specialized training and education, along with the promotion of a participative culture, emerge as relevant strategies.
Evaluating the impact of patient involvement in health technology assessments (HTA) may help improve practices and avoid ineffective activities. Evaluation, however, continues to be infrequent, inconsistent, and often only relates to process quantity or quality. The Patient and Citizen Involvement in HTA Interest Group (PCIG) within Health Technology Assessment International set out to contextualize this impact to support evaluation.
Methods
Given the lack of established methodology to measure impact, the team performed a qualitative analysis of first-hand accounts about perceived changes in HTA due to involvement of patient stakeholders. A questionnaire was developed, piloted, and rolled out to collect personal perspectives from stakeholders with relevant experience. The stories were analyzed in the aggregate to identify themes in the data.
Results
From January 2019 to September 2021, twenty-four responses were collected through PCIG’s network. Responses (including one joint industry-HTA body submission) came from patient representatives (12), HTA bodies (11), and industry representatives (2) from North America (5), South America (3), Europe (13), and Asia Pacific (3). Based on themes commonly reported, a three-domain framework for evaluating impact is proposed: impact on basis of HTA result or recommendation, impact on HTA body, and impact on patient participants. The framework includes components under each domain to support reporting.
Conclusions
Using the Three-Domain Impact Framework may be useful in identifying, evaluating, and communicating the value of patient involvement in HTA. Enhancing and increasing reporting practices may improve transparency and facilitate process improvements for meaningful integration of patient stakeholders into HTA appraisals across jurisdictions.
The Patient Involvement (PI) Interest Group of the Spanish Network of Health Technology Assessment Agencies (RedETS) was set up in 2017 by a group of health technology assessment (HTA) researchers interested in PI. Since its inception, training and capacity-building to support PI and patient-based evidence in HTA processes has been one of its main aims. The objective of this work was to identify the needs and priorities related to training and capacity building activities to be developed within the framework of the PI Interest Group.
Methods
The PI Interest Group met on November 14, 2022, for its Annual Meeting. The group discussed the needs, priorities and possibilities on training, and carried out a prioritization exercise. For this purpose, a self-reported and anonymous questionnaire was used, which included 16 training activities. Every item was scored with a Likert-type scale ranging from 0 to 10.
Results
The questionnaire was answered by twenty participants. The most highly rated training activities (mean less than or equal to 8) were: qualitative evidence synthesis (8.75); PI case studies (basic (8.65) and advanced (8.56) level); quality assessment tools for qualitative evidence (8.37); and qualitative research (8.11). Other proposals scoring above 7 points were: ethical aspects related to PI, evaluation of patient participation and impact, identification and recruitment procedures, and discrete choice experiments. The group agreed to organize bi-monthly webinars and three structured training activities for the whole RedETS network on: Qualitative Evidence Synthesis, Qualitative Research and PI Case Studies.
Conclusions
The prioritization of training activities according to PI Interest Group members allowed planning a tailored capacity-building program adapted to the needs of RedETS.
While the impact of health technology assessments (HTAs) is often not evaluated, some HTA bodies measure the impact of patient involvement in their processes. Evaluating how patient involvement is perceived by all stakeholders may help to improve practices and avoid activities that unduly burden patient and HTA communities. Frameworks and tools have been designed to analyze the impact of patient engagement along the healthcare development lifecycle. Reporting on the impact of patient involvement in HTA-specific activities, however, continues to be infrequent, unstandardized, and not comprehensive.
Having a common framework to characterize and report on the impact of patient involvement may enable this practice to be optimized and harmonized across HTA contexts.
Methods
The Patient and Citizen Involvement Interest Group (PCIG) within Health Technology Assessment International set out to contextualize this impact and support reporting. A questionnaire was developed, piloted, and rolled out to collect multistakeholder personal perceptions of the impact of patient involvement in individual HTAs. Questions included: “What difference did you feel patient involvement made in the HTA activity?” and “What would have been missed without patient involvement?”. From January 2019 to September 2021, 24 responses (including one joint submission) were collected through the PCIG’s network from HTA bodies (11), patient representatives (12), and industry representatives (2) from North America (5), South America (3), Europe (13), and Australia (3).
Results
Common themes were extracted from these experiences to characterize the impact of patient participation in HTA processes. Based on these commonalities, a harmonized framework consisting of three “domains” is proposed: impact on the decision-making process; impact on patient stakeholders; and impact on the HTA body. The framework includes a set of items under each domain to support reporting.
Conclusions
By having common language and measures, the HTA community can harmonize processes across jurisdictions to evaluate and communicate the value of patient involvement in HTA. Improving consistent reporting may facilitate more efficient process improvement for meaningful integration of patient stakeholders into HTA decision-making.
Immersion in water is a non-pharmacological method for pain relief during childbirth. The aim was to describe the experiences, values and preferences of women regarding water immersion during childbirth identified in the evidence.
Methods
A systematic review and thematic synthesis of qualitative evidence was conducted. Databases were searched from 2009 to 2022 and screened for inclusion using pre-determined criteria. Studies that used qualitative methods for data collection and analysis to investigate the opinions of women or health professionals in hospital settings were included. Non-qualitative studies, mixed methods studies that did not separately report qualitative findings and studies in languages other than English or Spanish were excluded. The Critical Appraisal Skills Programme Qualitative Research Checklist was used to assess study quality and findings were synthesized using thematic synthesis, as described by Thomas and Harden.
The final report was reviewed by several categories of health professionals that care for mothers and infants, as well women.
Results
Thirteen studies met inclusion criteria and were included in this review. Nine studies have been identified that reflect the experience of women in relation to immersion in water during childbirth, a study exploring the factors that determine the use of immersion during childbirth according to the point of view of both women and midwives, and three more studies on midwives’ experience with water immersion during childbirth. In the qualitative studies the following key themes emerged: Reasons identified by the women/professionals for choosing a water birth, benefits experienced in water births and barriers and facilitators of immersion in water during childbirth.
Conclusions
The evidence from qualitative studies indicates that women associated water birth with a sense of autonomy and control over labor, and a lower level of associated pain. Further, a water birth was considered a positive experience. From the point of view of midwives, to make water births safe, there is a need for adequate resources, as well as rigorous standardized protocols.
Certain doubts about immersion in water during birth mainly regarding the safety of the infant, warrant analysis of the data to determine whether immersion in water during childbirth is safe and effective. The aim is to describe the situation regarding the use of water immersion during childbirth in hospitals of the Spanish National Health System across Spanish Autonomous Regions and Cities.
Methods
A questionnaire was developed to assess the use of water immersion on maternity wards of National Health System hospitals. The survey was reviewed by several categories of health professionals and stakeholders. The online questionnaire was distributed via email. A database was created using the Microsoft Excel 365® computer program. Quantitative results were described through percentages and frequency distributions. In the case of free responses, a content analysis was performed, coding the responses into different categories.
Results
Regarding the status of water birth in Spain, the availability of the option of water birth varies across hospitals of the National Health System. Forty-six hospitals in 13 autonomous regions indicated that they had birthing pools on their delivery wards. Among these hospitals, 20 percent reported having more than 10 years of experience in water births, 45 percent between five and 10 years and 35 percent less than five years. Of the 46 responses received, 78 percent of the hospitals indicated that there was a demand for information on waterbirth by pregnant women. Regarding the existence of criteria for the adequate selection of pregnant women who could opt for immersion in water during childbirth, 89 percent of the hospitals indicated that these did exist, while 11 percent indicated that they did not have agreed criteria for the selection of candidates for water birth.
Conclusions
The availability of the option of water birth varies in hospitals across the Spanish National System. All the hospitals that have birthing pools offer them in the first stage of labor (dilation), while 32 percent also use them in the pushing stage and 15 percent during delivery of the placenta. It would be advisable to have standardized protocols and training to ensure the possibility that all pregnant women, regardless of their place of residence, can safely opt for water immersion during childbirth with satisfactory results.
Aromatherapy is the field of herbal medicine that uses essential oils distilled from flowers, roots, and herbs and other plant compounds to promote physical and psychological well-being. Essential oils are absorbed into the body in different ways, with the inhaled and topical routes being the most widely used. The aim of this review was to critically evaluate and synthesize the available scientific evidence on the efficacy and safety of aromatherapy for the management of any therapeutic indication. This report was requested by the Spanish Ministries of Health and Science and Innovation.
Methods
An overview of systematic reviews (SRs) was performed. The MEDLINE, Embase, CINAHL, and PsycINFO databases were searched for literature published from January 2006 to August 2021. SRs reporting the efficacy and safety of aromatherapy were included. We applied no restrictions in terms of administration route or essential oil used. Two reviewers independently performed screening and selection, data extraction, and quality assessment.
Results
We included 74 SRs covering a wide variety of populations and settings. The most reported outcome was anxiety, followed by pain, and the most commonly used essential oil was lavender. Fifteen SRs reported mild adverse events with aromatherapy. Only 11 SRs assessed the certainty of evidence using the GRADE approach. Aromatherapy reduced heart rate and likely reduces anxiety and breathing rate in patients with cardiovascular diseases. Aromatherapy probably also reduces pain in women with primary dysmenorrhea. Additionally, it may reduce blood pressure, acute pain, subjective stress, and the need for antiemetic drugs after surgical procedures. However, the evidence was very uncertain regarding the effect of essential oils on anxiety, pain, and quality of life in patients with cancer, anxiety and pain after a caesarean section, and dental anxiety.
Conclusions
Aromatherapy may be useful for managing psychological and physical symptoms in different settings. However, the conclusions of this review are not definitive because of the moderate to high risk of bias in many of the primary studies included in the SRs.
FreeStyle Libre System (FSL) is a minimally invasive technology, which provides frequent information about interstitial glucose levels, which allows adjustment of insulin dose and a reduction in the number of fingersticks. This study aims to evaluate the effectiveness and safety of FSL in childhood and adolescence.
Methods
Prospective case series in 27 Spanish hospitals. Patients aged 4-17 years with type 1 diabetes mellitus (T1DM) were included. Follow-up was done at 3, 6 and 12 months after starting to use the FSL. Outcome measures were HbA1c levels, acute complications of DM (severe hypoglycemia, ketoacidosis), DM knowledge, health-related quality of life, satisfaction and adverse effects. Biochemical glycemic outcomes (e.g., glycemic variability, time in therapeutic range) were available from 3 to 12 months. Mixed regression models with repeated time measurements were implemented.
Results
The mean age of patients was 12.6 years, with 56.4 percent had HbA1c values above 7.5 percent at baseline. This subgroup significantly improved their HbA1c levels at 3, 6 and 12 months (-0.46%, -0.44% and -0.35%, respectively). Patients with controlled HbA1c levels significantly worsened at 12 months (0.29%). There was a significant reduction in severe hypoglycemic episodes, but only in the multiple imputation analysis. In patients controlled at baseline, there were significant reductions between 3 and 12 months in the percentage of time under 55mg/dl (-0.64%), above 250mg/dl (-1.8%) and glycemic variability (-2.6%). In uncontrolled patients, there was a significant reduction in time above 250mg/dl (-5.8%) between 3 and 12 months follow-up. There was no significant improvement in knowledge about disease, although general self-perceived health worsened and general satisfaction improved. Mild adverse events such as skin reactions (14%) and discomfort or pain (11.3%) with no significant reductions in follow-up were recorded.
Conclusions
The use of FSL in childhood and adolescence with T1DM produces a significant reduction in HbA1c levels in patients with uncontrolled HbA1c levels along with a reduction in severe hypoglycemic episodes (in the multiple imputation analysis). FSL-related adverse effects are considered mild.
Patient involvement (PI) has become a key priority to the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). As part of the national strategy to promote PI, an interest group was created in 2017 to share knowledge, develop methodologies and standardize PI processes. The aim of this work is to analyze the main activities of the Patient Interest Group 5 years after its launch and to reflect on possible needs and challenges.
Methods
Narrative description and an in-depth analysis of the main activities of the Interest Group from 2017 to the present.
Results
The group is composed of HTA researchers from the 8 regional agencies in Spain and is supported by the Ministry of Health and the RedETS council. It currently has the participation of 26 researchers, organized into different working subgroups. The initial lines of work were the analysis of the situation, the development of procedures, and the initiation of training materials for patients on HTA. At present, the main projects are the development of metrics for evaluating the impact of patient participation, the development of procedural materials to promote methodological process standardizaton (e.g., a flowchart with the main process steps, checklists, templates), and the design and piloting of virtual training for patients in HTA. New lines include the analysis of the ethical challenges of PI and the feasibility of setting up an HTA patient registration system and a patient forum to facilitate participation. In addition, the interest group has promoted the exchange of relevant information for PI and the organization of capacity building activities.
Conclusions
The RedETS Patient Interest Group is encouraging the development of activities, reflection on collective experiences, and tools that facilitate PI in Spain. Among the main challenges are the need to ensure the quality and applicability of PI and to analyze the views of patients who have actively participated in HTAs.
GesPeDia is a web-based application that provides aggregate clinical information, using outcome and process indicators, and disaggregated patient information. Information is obtained from the electronic medical records. GesPeDia aims to promote people-centered care, improve monitoring of patients’ health outcomes and quality of professional performance. This study aims to evaluate usability, acceptability and satisfaction of GesPeDia.
Methods
Nineteen evaluators were included (2 management technicians, 9 health center directors and 8 endocrine consultants). They had access to GesPeDia for two months. Perception of their usefulness for decision-making, acceptability and design satisfaction were measured with an online questionnaire. In addition, suggestions for improvements in the app’s functionalities were collected. Finally, a sample of the evaluators were included in a semi-structured interview to deepen the analysis of dimensions. A descriptive analysis of the data was performed.
Results
The questionnaire was completed by 10 professionals, with mean age of 51.1 years and professional experience 16.5 years. Among the evaluators, 60 percent considered the app quite useful and only 10 percent found it inappropriate for their daily activities. Each of the indicator blocks was rated quite useful. Eight percent considered GesPeDia moderately fast, although for 20 percent navigation within the app was not very intuitive. Appearance was positively valued by 80 percent, despite the fact that 30 percent considered that design does not favor the understanding of contents. Seventy percent considered degree of reliability, relevance and clarity of the contents to be high. Most indicated that information provided by GesPedia is complete for decision-making.
Conclusions
GesPeDia is valued positively by evaluators as a decision-making tool.
Telemedicine has been introduced in health services, but uncertainties about the real value of this strategy in the management of neurological diseases remain.
Methods
A systematic review was undertaken of available scientific literature on the safety, effectiveness, and cost effectiveness of telemedicine combined with in-person visits, compared with usual care, for the treatment and follow-up assessment of patients with neurological diseases. The overall effect size for each neurological disease was estimated using meta-analysis. An economic analysis was performed from the societal and Spanish healthcare system perspectives.
Results
Two economic studies were included for cost effectiveness and 25 randomized controlled trails (n=8,976 patients) were included for the effectiveness and safety assessment (11 on cerebrovascular diseases, four on Parkinson’s disease, three on multiple sclerosis, two on epilepsy, and one each on brain damage, dementia, spina bifida, migraine, and cerebral palsy). The types of telemedicine evaluated included: virtual visits (11 studies); telerehabilitation (seven studies); telephone calls (three studies); smartphone apps (two studies); and online software for computers (two studies). Subgroup analysis by type of telemedicine indicated no discernible effect for telemedicine combined with in-person visits on most of the outcomes analyzed for the various neurological diseases. Given the heterogeneity of diseases, types of telemedicine, and the results observed, a cost-minimization analysis was conducted. Combining telemedicine with in-person visits would cost EUR 2.55 per patient from the perspective of the healthcare system, but it would result in cost savings (EUR 27.34 per patient) from the societal perspective.
Conclusions
The safety and effectiveness of combining in-person visits with telemedicine was similar to that of usual care, but it could be a cost-saving strategy in Spain from a societal perspective.
Diabetes mellitus (DM) is one of the most frequent metabolic complications associated with pregnancy, affecting both the prognosis of the pregnant woman and the newborn. Pregestational DM type 1 (T1DM) and type 2 (T2DM) and gestational DM (GDM) are associated with an increased risk of pregnancy complications such as miscarriage, fetal malformations, macrosomia, preeclampsia, and neonatal hypoglycemia, among others. The aim of this review was to evaluate the efficacy and safety of using the Dexcom G6 device (Dexcom, Co., USA) to continuously self-monitor blood glucose levels during pregnancy. This report was requested by the Spanish Ministry of Health.
Methods
We systematically searched for articles published to July 2021 in the MEDLINE, Embase, and Web of Science databases. We included experimental and observational primary studies addressing the safety, efficacy, and cost effectiveness of the Dexcom G6 device for gestational and pregestational diabetes.
Results
Two non-comparative prospective studies were identified. One study of 25 pregnant women with T1DM, which evaluated glycemic control and complications during pregnancy and postpartum, reported stable hemoglobin A1c levels during gestation in women using the Dexcom G6 device. The percentage of time spent in the therapeutic glucose range (63 to 140 mg/dL) was 59 percent; 38 percent was in the hyperglycemic range and 3 percent was in the hypoglycemic range. Although some patients reported mild erythematous and edematous reactions to the sensor, no moderate or severe reactions or infections occurred at the sensor insertion site. The other study in pregnant women with T1DM (n=20), T2DM (n=3), or GDM (n=9) showed adequate accuracy of the Dexcom G6 device, compared with the reference method, especially when the sensor is placed on the arm.
Conclusions
Randomized controlled trials are required to assess the effectiveness and safety of the Dexcom G6 device in maintaining adequate glucose control during pregnancy in women with DM. Studies are also needed to compare the Dexcom G6 device with conventional capillary blood glucose self-monitoring or other monitoring methods. No cost-effectiveness studies have been conducted for the Dexcom G6 device in this patient population.
Patients have knowledge, perspectives and experiences that are unique and can make an essential contribution to Health Technology Assessment (HTA). However, in order for their participation to be effective, they need to be able to understand how HTA reports are generated and the decision-making processes that they inform. The aim is to describe the development and virtualization of training materials for patients, as well as to their implementation in a pilot study.
Methods
A working group from Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) agencies was created to develop educational materials in collaboration with patients. The content was based on international initiatives and feedback from the working group. The project was initiated in November 2020. The team consisted of HTA researchers, technicians with experience in training and virtualization and patients. The final version was obtained after an iterative process and refinement of the content and design.
Results
The materials were published in complete and summary versions, and they were translated into Catalan, Basque and Galician. The online course was designed in an e-learning platform (Moodle) with the aim of being implemented by each of the agencies. The materials include relevant and summarized information on HTA processes, current framework at national and European level, and the role of patients in HTA. Health research and the importance of qualitative and quantitative methods are also addressed. The course also includes a module of practical aspects of patient and citizen participation for achieving an effective contribution to HTA. The course is being piloted with patients in different regions in Spain. The objective of the pilot is to evaluate the usefulness and satisfaction with the course, and it has been designed with the purpose of incorporating the pertinent modifications in the course.
Conclusions
The online training course is intended to facilitate the acquisition of knowledge related to the processes and tools of HTA for patients, as well as to inform them in what phases and in what way they can participate. The pilot will provide relevant information on its use in practice. It is expected that the course will favor capacity building and patient involvement.
Qualitative research is being increasingly integrated in heath technology assessments (HTA) within the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). Qualitative research methodological guidelines are given in RedETS HTA guidelines and the Patient Involvement Strategy. A specific methodological guideline to systematically review qualitative studies was published in 2007 and is pending its update. The impact of their implementation is unknown. The aim of this work is to analyze the techniques, impact and reporting of qualitative research (primary and secondary) in HTAs.
Methods
A manual search of the HTAs published in the last 5 years in RedETS was conducted to locate assessments that include qualitative research. To ensure a complete identification, RedETS agencies and units were consulted to provide information about the assessments that have used qualitative techniques in their development over the past 5 years. A content analysis of the selected assessments was conducted to analyze the techniques, impact and reporting of qualitative research in HTA.
Results
In the past five years, focus groups, semi-structured interviews, evidence synthesis of observational studies including qualitative studies have been used and integrated in HTA in RedETS. Most of them have been linked to patient involvement facilitation or the inclusion of patient perspectives in HTA. Qualitative research has been used to analyze patient’s experiences and values, to elicit and select important outcome measures for patients, to research for barriers-facilitators for technology implementation and to inform evidence to decision frameworks.
Conclusions
Qualitative primary and secondary research is being used in HTA in Spain. It is mainly linked to patient involvement strategies both to elicit patient perspectives directly or to collect patient-based evidence. The impact of qualitative research in HTA is broad and diverse, extending from the scope of the assessments to the drafting of the recommendations.
Long-term cocaine use is associated with a wide range of cognitive deficits and neuropsychiatric pathologies. Repetitive transcranial magnetic stimulation (rTMS) is an emerging therapeutic strategy that stimulates the prefrontal cortex and may improve cognitive inhibitory control and decision-making. This systematic review aimed to evaluate and synthesize evidence on the safety, effectiveness, and cost effectiveness of rTMS for the treatment of cocaine addiction.
Methods
A systematic review of the literature was carried out. The following electronic databases were searched to identify relevant studies published from inception to October 2020: MEDLINE, Embase, CINAHL, PsycINFO, the Cochrane Central Register of Controlled Trials, and Web of Science. Randomized controlled trials (RCTs), non-randomized controlled trials (nRCTs), case series studies, and full economic evaluations were included.
Results
A total of 12 relevant studies were identified, which included five RCTs, one nRCTs, and six case series studies. None of the studies reported data on cost effectiveness. The results indicated that rTMS reduces cocaine cravings and the number of doses consumed. No serious adverse effects were observed.
Conclusions
The ability to modulate the craving for cocaine in a specific way with non-invasive brain stimulation techniques, such as rTMS, could be a new adjunct to the behavioral treatment of addiction, especially for cocaine use where there is currently no approved pharmacological treatment. Despite the low quality of the included studies, preliminary results indicate that rTMS may reduce cocaine use and cravings. In any case, since this effect is considered moderate, future studies with larger sample sizes and longer follow up are required.
Telemedicine strategies have been broadly introducing in health services during the COVID-19 pandemic, including in care of neurological diseases.
Methods
A rapid realist review was conducted using EUnetHTAs Core Model 3.0 and GRADE evidence to decision frameworks were used as frameworks to describe the ethical, legal, organizational, social and patient aspects (ELSI+) related to the use of teleneurology (TN) A scoping multistakeholder meeting helped defined the scope and research questions of the assessment. Patient representatives, clinicians, scientific society representatives with relevant experience in TN were invited and participated. Industry representatives were also present. Systematic searches for ethical, legal, organizational, social and patients related aspects were conducted. Additional manual searches contributed to contextualize these dimensions in the Spanish context. A narrative synthesis was undertaken.
Results
Main results of the assessment of the ELSI+ aspects of TN were described. TN applications are diverse depending on the condition, objective of care and technology used. The implementation of TN lacks specific legal frameworks which implies legal uncertainty. TN may increase geographical accessibility to neurological care in remote areas and by reducing difficult commuting to specialized care centers. Nevertheless, accessibility is challenged by reduced access to technology, the digital divide, lack of health literacy or technologies not adapted to functional diversity. Therefore, equity is not guaranteed if it is offered as a non-voluntary basis or with no support. TN tends to be accepted by patients and carers if it has enough quality, saves travelling time and costs and does not dehumanize care as it is perceived as more flexible and convenient. Quality of TN needs an interdisciplinary team with skills to coordinate organizational aspects of the implementation which include among others, the planification of the support to patients and carers before, during and after the consultation. Health professionals may also need to learn adapted communicational and technological skills.
Conclusions
The implementation of TN poses many ethical, legal, organizational, social or patient-centered challenges.
Autogenic training consists of reaching a state of deep relaxation through mental representations of physical sensations in different parts of the body. It is a promising technique for improving the psychological well-being of people with chronic diseases, but there are no clinical practice guidelines recommending the use of autogenic training in this population. The aim of this work was to identify, critically evaluate, and synthesize the available evidence on the safety and effectiveness of autogenic training in the prevention and treatment of medical conditions.
Methods
We conducted a systematic search for systematic reviews and randomized controlled trials (RCTs) in MEDLINE, Embase, CINAHL, PsycINFO, and the Cochrane Central Register of Controlled Trials. The selection and assessment of risk of bias of the included studies was carried out independently by two reviewers.
Results
A total of 2,420 references were identified after eliminating duplicates. Of these, 141 were selected for reading the full text, and 13 systematic reviews and 18 RCTs were included. Compared with no intervention or delayed treatment, autogenic training significantly reduced levels of anxiety and depression as well as some physical symptoms (e.g., headaches and atopic dermatitis).
Conclusions
Autogenic training could be useful for improving the psychological well-being and physical symptoms of patients with chronic health conditions and as an additional element in multicomponent intervention programs. However, these conclusions are not definitive due to the low number of studies available for each health condition and their high or unclear risk of bias.
In 2017, a Patient Involvement Interest Group (PIIG) was created in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) to facilitate and promote Patient Involvement (PI) in Health Technology Assessment (HTA). The PIIG proposed a decisional flowchart to guide researchers’ in decisions regarding PI methods in HTA. The flowchart proposed a combination of direct involvement and incorporation of patient-based evidence depending on the scope and the aims of the assessment.
This work aims to present the flowchart and the results of the evaluation of the latest experiences in PI in HTA in RedETS (2018–2020), including direct-involvement and patient-based evidence.
Methods
A survey was sent to the HTA researchers who implemented PI initiatives in RedETS assessments. The survey asked to describe their experiences, lessons learned, challenges and added value regarding the use of direct-involvement, systematic reviews (SR) and primary studies. A descriptive analysis was performed and the results were discussed in an online PIIG workshop.
Results
Thirty-two assessments included direct PI, twenty-one SR synthesized qualitative and quantitative studies about patient experiences, values and preferences and eight included primary studies, mainly of qualitative design. Recruitment and the lack of methodological resources were the main barriers both for direct PI and primary studies. Relevance of the included studies was the main barrier for SR. Added value was found in all PI methods. Direct-involvement had an impact on the project plan and PICO definition, outcomes relevance, information about the health condition and treatments. SR contributed with relevant patient-based evidence, deeper assessment of patient experiences, values and preferences and implementation factors. Primary studies developed new or contextualized knowledge directly applicable to decision-making.
Conclusions
The PI flowchart has served to facilitate the incorporation of patient input in HTA reports. The different approaches implemented have allowed to provide relevant and well-grounded data in each report to inform decision-making in patient-centered healthcare provision, but it is necessary that specific training and resources are provided to enable adequate and timely implementation.