Experiences of patients with endometriosis with a digital health application: a qualitative analysis.

BACKGROUND: Endometriosis is a frequent disease in women of reproductive age in which the endometrium occurs outside the uterine cavity. Multimodal treatment approaches are necessary due to loss of quality of life and the chronic nature of the disease. Digital health applications (DiGa) are becoming increasingly important. This research project investigates how a healthcare app can influence the subjective experience of illness in patients with endometriosis. METHODS: Empiric data were collected through semi-structured interviews. Data analysis was carried out using qualitative focussed interview analysis. Reliability was ensured by joint interdisciplinary and interprofessional evaluation of the interviews by experts and those affected. RESULTS: Ten patients with endometriosis and the prescribed healthcare app Endo-App© were examined. Categories were defined from the superordinate categories "Factors influencing the experience of illness" and "Evaluation of the app". The app provided reliable information, promoted self-efficacy through exercises and strengthened the perception of the individuality of the illness. It helped to minimise nocebo effects from internet research and enabled a positive change of perspective. Patients criticised the time required for data input and had data protection concerns. The educational elements were often seen as redundant. Some patients only used the app briefly, or not at all. CONCLUSION: Once a DiGa has been prescribed, it may be useful to explain its use on an outpatient basis and validate regular use. Blind re-prescribing of DiGas should be avoided. Younger patients with a recent diagnosis or patients following rehabilitation may benefit more from prescribing.

Using value-focused thinking to elicit oncologic inpatients' life and treatment objectives: a qualitative interview study.

OBJECTIVE: Value-focused thinking (VFT) is a decision-making method that places the qualitative elicitation of decisionmakers' objectives at the beginning of the decision-making process. A potential healthcare application of VFT is to elicit patients' objectives to better understand what matters to them. Only then can treatments be tailored accordingly. This is particularly important for patients with life-threatening diseases such as cancer. Thus, this interview study used VFT to elicit the life and treatment objectives of non-terminal oncologic inpatients. METHODS: Fifteen cancer inpatients (median age 66 years) were sampled in a German university hospital in September 2019. The participants completed questionnaires, the data of which were used to semi-structure the subsequent interviews. Data were analysed using inductive category formation to identify objectives in the transcribed interviews. RESULTS: Sixteen objectives in five life domains (optimising physical wellbeing, optimising mental wellbeing, optimising personal life, optimising family life and optimising financial life) were identified. CONCLUSION: Comparison of the findings with previous research indicated that VFT is a reliable approach to elicit patients' objectives. The identified objectives could increase understanding of the outcomes that cancer inpatients care about.

A Qualitative Interview Study on Expanded Access Clinical Trials for Compassionate Use in Japan.

Purpose: An expanded access clinical trials (EACTs) provides exceptional patient access to investigational new drugs for life-threatening diseases for which no effective treatment exists. Based on public information, we have studied EACTs since 2016, when the EACT system was launched in Japan. In this study, we investigated the reality of EACTs by interviewing pharmaceutical companies and clarifying how they view them. Patients and Methods: We conducted semi-structured interviews with 10 pharmaceutical companies developing new drugs. This study aims to clarify the status of EACTs, so we selected pharmaceutical companies that develop innovative drugs for which they may perform EACTs (however, experience in conducting EACTs was optional). Results: All those surveyed were aware of EACTs. Twelve access clinical trials were conducted, and the EACT implementation rate for pivotal clinical trials was 2.5%. The most common reason for implementing an EACT was "requests from physicians and medical institutions" (nine companies, 90.0%), and the most common reason for not implementing an EACT was "the applicability of the system" (five companies). Improvements to EACTs were identified by eight companies (80.0%); financial assistance by six companies (60.0%); reducing the scope of data to be collected and simplifying the procedure by six companies (60.0%). Seven companies (70.0%) responded that a Single Patient Investigational New Drug Application should be conducted, suggesting that the system should be revised. Conclusion: An interview survey of ten pharmaceutical companies developing new drugs in Japan regarding expanded access clinical trials indicated that there were issues with the system. Many wished to improve the system by establishing a single patient access system, supporting resources, and simplifying procedures. Based on our interviews with 10 Japanese pharmaceutical companies, it was found that the system needed to be improved by introducing a single patient access system, providing supporting resources, and simplifying procedures. In Japan, about eight years have passed since EACT was established, and it appears a revision of the EACT legislation is due.

Establishment and analysis of quality index system for pediatric tumor nursing.

BACKGROUND: Nursing management considers nursing quality management at its core. Evaluation indexes of nursing quality not only control nursing quality, measure work enthusiasm, and judge the difference in nursing levels but also help nurses accurately understand the satisfaction degree of patients. OBJECTIVE: To analyze pediatric tumor nursing quality evaluation indexes and establish a scientific and rigorous index system of children's nursing quality. METHODS:   Based on the "structure-process-result" in this study, the Delphi method was used to carry out questionnaire investigations and opinion collection for domestic experts in pediatrics, pediatric oncology internal medicine, and pediatric oncology surgical care and clinical aspects two times. In addition, the Kendall coordination coefficient and analytic hierarchy process were used to determine the content of indicators at all levels, set the weight, and finally establish the quality index system of pediatric tumor nursing. RESULTS: The response rate of 27 experts in the first round of the questionnaire was 100%, Ca0.77, Cs,0.73, Cr0.75, and the W value of the expert coordination coefficient was 0.315. In the second round of 27 expert consultations, the reply rate was 96%, Ca0.81, Cs0.80, Cr0.805, and the specialist coordination coefficient W value was 0.369. After two rounds of consultation, the importance evaluation scores of each indicator ranged from 3.31 to 4.88 and 3.29 to 5.00, respectively, and more than 94.7% of the indicators' importance evaluation scores were higher than 3.50. Finally, 3 Level-1 indicators, 12 Level-2 indicators, and 54 Level-3 indicators are established. CONCLUSION: This study has established a simple, comprehensive, and scientific quality index system for pediatric tumor nursing, highlighted the characteristics of pediatric tumor nursing, and provided an evaluation system for specialized nursing of pediatric tumors to more standardized pediatric tumor nursing and contribute to the sustainable and scientific development of pediatric tumor nursing.

A qualitative approach to assess the opinion of physicians about the challenges and prospects of pharmacogenomic testing implementation in clinical practice in Greece.

BACKGROUND: Pharmacogenomics (PGx) constitutes an important part of personalized medicine and has several clinical applications. PGx role in clinical practice is known, however, it has not been widely adopted yet. In this study, we aim to investigate the perspectives of Greek physicians regarding the implementation of PGx testing in clinical practice and the key issues associated with it. METHODS: Fourteen interviews were conducted with physicians of various specialties for which PGx applications are available. A semi-structured interview guide was utilized based on the Consolidated Framework for Implementation Research (CFIR) context and the Diffusion of Innovation model. Transcripts were coded independently and compared by two members of the research team. Descriptive statistics were generated using Microsoft Excel. RESULTS: Six main themes emerged: awareness and use of PGx testing; source of information; key stakeholders of the PGx supply chain, their interactions and change agents; clinical benefit and significance of PGx testing; barriers and lack of reimbursement; and recommendations to boost the PGx adoption rate. Most respondents were aware of PGx applications, but only three had already recommended PGx testing. Peer-reviewed journals along with clinical guidelines were regarded as the most used source of information while stakeholders of the PGx supply chain were discussed. PGx was considered that promote patient-centered care, enhance medication clinical effectiveness, decrease the risk of side effects, and reduce healthcare costs. Lack of reimbursement, scarcity of resources, and high PGx cost were the foremost barriers affecting PGx adoption. CONCLUSIONS: It was concluded that if case PGx testing is reimbursed and physicians' training is reinforced, PGx implementation will be boosted and improved shortly.

Patients' perspectives of the digital counselling competence of healthcare professionals-A qualitative descriptive study.

AIM: To describe the perspectives of patients using digital services on the digital counselling competence of healthcare professionals. DESIGN: A descriptive qualitative interview study. METHODS: The analysed data were collected in Finland during the spring of 2023 via 11 individual, semi-structured interviews from participants who had received video-mediated counselling. The interviews were carried out online through Microsoft Teams and adhered to an interview guide using main and ancillary questions. The data were analysed using inductive content analysis. RESULTS: The patients' perspectives of healthcare professionals' digital counselling competence were related to five categories: (1) competence in preparing for video-mediated counselling, (2) digital competence in implementing the video-mediated counselling, (3) competence in interacting with the patient during the video-mediated counselling, (4) competence in supporting the patient's self-management in video-mediated counselling and (5) competence in self-development as a digital counsellor. CONCLUSION: The results of this study indicate that healthcare professionals need to possess a wide range of digital counselling competencies when providing video-mediated counselling. This study thus lays the groundwork for future studies of patients' perspectives of healthcare professionals' digital counselling competence. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The results of this study can be used to develop healthcare professionals' digital counselling competence and patient-centered care. The presented insights can also be used to map further research topics. REPORTING METHOD: The Consolidated criteria for reporting qualitative research (COREQ) checklist was used when reporting the results. PATIENT OR PUBLIC CONTRIBUTION: Patients who had experience in using digital services participated in the data collection of this study. IMPACT: What problem did the study address? Healthcare professionals may well need to develop new competencies as counselling is increasingly moving to digital environments. What were the main findings? The main areas of digital counselling competence that emerged from the patients' perspectives were competence in preparing for video-mediated counselling, digital competence, competence in interacting with the patient, competence in supporting self-management and competence in self-development as a digital counsellor. Where and on whom will the research have an impact? The research can be used to build and develop healthcare professionals' digital counselling competence, as well as improve the delivery of patient-centered care.

Cancer-related cognitive impairment in older adults with acute myeloid leukemia treated with hypomethylating agents and venetoclax chemotherapy: a longitudinal descriptive study.

PURPOSE: To explore cancer-related cognitive impairment (CRCI) in older adults with acute myeloid leukemia (AML) receiving venetoclax in combination with hypomethylating agents or low-dose cytarabine chemotherapy. METHODS: This study is a longitudinal, qualitative descriptive study. Participants were recruited using purposive sampling. Semi-structured interviews were conducted among 11 older adults with AML at cycle 2, cycle 4, and cycle 7 of chemotherapy. An early end-of-study interview was conducted for those who changed treatment plans during the study follow-up. RESULTS: A total of 22 transcripts were included for thematic analysis. Four themes emerged: (1) CRCI experiences, (2) impact of CRCI, (3) CRCI coping strategies, and (4) perceived CRCI-related factors. Older adults with AML experienced challenges in memory, language, and attention both intermittently and daily. These cognitive changes impacted their emotion, daily activities, social connection, and their caregivers' responsibilities. Hence, these older adults with AML developed problem-solving and emotional coping strategies to cope with CRCI. Older adults with AML also identified demographic, physiology/clinical, psychological, and other factors that might contribute to CRCI. CONCLUSION: This study offers important insight for clinicians to understand how older adults with AML experience CRCI and how it impacts their daily routines. It indicates that clinicians should ask patients about their experience with cognitive changes at each encounter to provide support or coping strategies as needed to prevent CRCI from further hindering their quality of life.

Patient Experience of Stiffness With Knee Osteoarthritis: An Interpretative Description Study.

INTRODUCTION: Knee OA (KOA) can lead to pain, loss of muscle strength, and changes in gait. Knee stiffness is a classic feature of KOA that can increase the risk of falls but has been understudied. OBJECTIVE: To evaluate the impact of knee stiffness, the factors influencing the severity of stiffness, and the repercussions on participation for patients with KOA. METHODS: This qualitative study used an interpretive description approach. Purposeful sampling was used for patients with KOA over 45 years of age, fluent in English, diagnosed with KOA and reported KOA stiffness within the last 6 months. Participants were recruited through social media and Ontario clinics. Semi-structured interviews were conducted over the phone or using zoom, recorded, and transcribed verbatim. Open, axial, and selective coding were used to identify clinically relevant themes. RESULTS: Twelve participants (5F, 7M) with a mean age of 60 years were included. The five themes identified include elusive and variable perceptions of joint stiffness, inactivity or too much activity exacerbates stiffness, adapting to the ebb and flow of symptoms, risk experiences and safety fears leads to reduced participation, and KOA stiffness impairs quality of life. CONCLUSION: This study highlights characteristics of knee stiffness, consequences on participation, and quality of life for people with KOA. Monitoring knee stiffness for KOA is recommended for more appropriate treatment intensity, which could improve adherence to a home programme and potentially reduce the risk of falls.

The Relationship between Patient Self-Reported, Pre-Morbid Physical Activity and Clinical Outcomes of Inpatient Treatment in Youth with Anorexia Nervosa: A Pilot Study.

Links between premorbid physical activity (PA) and disease onset/course in patients with anorexia nervosa (AN) remain unclear. The aim was to assess self-reported PA as a predictor of change in percent median BMI (%mBMI) and length of hospital stay (LOS). Five PA domains were assessed via semi-structured interview in adolescents with AN at hospitalization: premorbid PA in school grades 1-6 (PA1-6); PA before AN onset (PA-pre) and after AN onset (PA-post); new, pathological motivation for PA (PA-new); and high intensity PA (PA-high). Eating disorder psychopathology was measured via the Eating Disorder Examination Questionnaire (EDE-Q), and current PA (steps/day) with accelerometry. PA1-6 was also assessed in healthy controls (HCs). Using stepwise backward regression models, predictors of %mBMI change and LOS were examined. Compared with 22 HCs (age = 14.7 ± 1.3 years, %mBMI = 102.4 ± 12.1), 25 patients with AN (age = 15.1 ± 1.7 years, %mBMI = 74.8 ± 6.0) reported significantly higher PA1-6 (median, AN = 115 [interquartile range IQR = 75;200] min vs. HC = 68 [IQR = 29;105] min; p = 0.017). PA-post was 244 ± 323% higher than PA-pre. PA1-6 was directly associated with PA-pre (p = 0.001) but not with PA-post (p = 0.179) or change in PA-pre to PA-post (p = 0.735). Lower %mBMI gain was predicted by lower baseline %mBMI (p = 0.001) and more PA-high (p = 0.004; r2 = 0.604). Longer LOS was predicted by higher PA-pre (p = 0.003, r2 = 0.368). Self-reported PA may identify a subgroup of youth with AN at risk of less weight gain and prolonged LOS during inpatient treatment for AN.

Some hope for a dimensional assessment? A critical review of psychometric validated (semi-)structured interview to assess eating disorders.

OBJECTIVE: Given that eating disorders (EDs) are considered one of the deadliest mental illnesses, the development of appropriate assessment instruments is a necessity. Despite the extensive literature on assessing EDs, there has been a lack of focus on semi-structured interviews. The purpose of this article is to provide a comprehensive review of psychometrically validated semi-structured interviews for EDs. METHODS: Included studies (N = 24) were required to present a semi-structured interview for EDs that has been validated through a psychometric process. The APA PsycNet, MEDLINE, APA Psycinfo, Pubmed, and Health & Psychosocial Instruments databases were searched. The literature search included publications through May 2024, with no earliest year restriction. RESULTS: A total of six instruments were identified and reviewed in terms of conceptual design, purpose and content, psychometric characteristics, and strengths and limitations. Three main findings were highlighted: (a) only half of the instruments are up to date; (b) the instruments are based on either a categorical or a mixed categorical-dimensional approach; and (c) the predominance of the categorical approach. CONCLUSIONS: The results are discussed regarding the conceptual approaches of the instrument to provide clinical and research implications. Despite the many strengths of the instrument, additional psychometric research is needed.

Psychometric Properties of the Diagnostic Interview for Sexual Dysfunctions in Women in a Symptom-Reporting Sample.

While structured clinical interviews are considered the gold standard for diagnosing mental disorders, respective instruments are still lacking in the field of sexual dysfunctions. The study evaluates the psychometric properties of the new Diagnostic Interview for Sexual Dysfunctions in Women (DISEX-F), which is based on the eleventh edition of the International Statistical Classification of Diseases (ICD-11) and the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), in a sample of 100 women with self-reported sexual problems. Participants were interviewed twice by trained diagnosticians with the DISEX-F. A third diagnostician evaluated the audio records of the initial interview. Participants also completed self-report measures of sexual functioning/distress and interview acceptance. The DISEX-F demonstrates excellent inter-rater reliability, good test-retest reliability, and strong convergent and discriminant evidence of validity. Furthermore, it achieves high acceptance among participants. Discordant diagnostic outcomes were especially linked to false differential diagnostic decisions and information variance in participants reporting. The results strongly support using the DISEX-F for women presenting with self-reported sexual problems in practice and research.

Establishing a course to train ICU nurses on prone position mechanical ventilation: A Delphi study.

AIM: To develop a comprehensive training course for training ICU nurses in prone positioning. DESIGN: A mixed study combining semi-structured interviews and two rounds of Delphi surveys. METHODS: We constructed a questionnaire after collecting data through a literature review and semi-structured interviews. We used the Delphi expert correspondence method to conduct two rounds of research among 17 experts in the field of critical illness. Data collection took place between May and August 2022. RESULTS: The effective questionnaire recovery rate was 88.2%. The expert authority coefficient was 0.876; the Kendall coordination coefficient was 0.402; the average importance score for each index ranged from 4.00 to 4.93; and the coefficient of variation for each index ranged from 0.05 to 0.19. We established 13 second-level indicators and 41 third-level indicators on prone position ventilation training according to three aspects: training contents, training methods and training assessment. The training system of prone mechanical ventilation for ICU nurses established in this study will provide an effective framework for training and evaluating the practical ability of prone mechanical ventilation for ICU nurses.

Collaboration matters: A randomized controlled trial of patient-clinician collaboration in suicide risk assessment and intervention.

BACKGROUND: Clinician collaboration can help high-risk individuals to manage their suicidal crises. However, limited research has directly examined how higher patient-clinician collaboration during assessment and intervention can effectively reduce suicidal ideation. This novel randomized clinical trial compared a high vs. low level of patient-clinician collaboration by pairing commonly used assessment (Structured Interview vs. Narrative Assessment) and intervention approaches (Safety Planning Intervention vs. Crisis Response Planning). We hypothesized that the interventions involving higher (than lower) patient-clinician collaboration during assessment (Narrative Assessment) or intervention (Crisis Response Planning) would lead to larger reductions in suicidal ideation. METHODS: Eighty-two participants with a history of suicide ideation and/or attempts were randomly assigned to one of the four interventions varying in patient-clinician collaboration. After attrition, sixty-six participants completed the study. Suicidal ideation via ecological momentary assessment was measured 14 days before and 14 days after treatment. RESULTS: Although the severity of suicidal ideation decreased in all groups, the two groups that included highly collaborative assessment had larger pre-post reductions in suicidal ideation (Narrative Assessment+Safety Plan; dwithin = 0.26, and Narrative Assessment+Crisis Response Plan; dwithin = 0.19) than the groups that included a checklist-based assessment (Structured Interview). LIMITATIONS: Longer follow-up periods with a larger sample would have provided an understanding of the durability of intervention effects. CONCLUSION: Results suggest that the inclusion of higher patient-clinician collaboration techniques during suicide risk assessment can effectively reduce suicidal thoughts. Thus, clinician-led collaborative risk assessment approaches can enhance the effects of safety planning-type interventions among patients with elevated risk for suicide versus checklist-based assessment approaches.

Perception of patients with retinal pathology on aspects of visual function and their management.

BACKGROUND AND OBJECTIVE: Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are highly prevalent. OBJECTIVE: To explore perceptions of patients with AMD or DR about the impact of the disease and treatment on their daily living activities. MATERIALS AND METHODS: Semi-structured interviews with a questionnaire developed from validated patient reported outcomes questionnaires. The questionnaire consisted of 19 questions about the disease and 9 about the treatment. The questions (items) were answered on a scale from 1 to 9. In addition, the patient interviewed was invited to make free comments on each question. Nine patients with AMD and 9 with DR were interviewed by videoconference or telephone call. A quantitative analysis of the responses and a qualitative analysis of the comments were carried out. RESULTS: The most relevant item for patients with AMD or DR is "Recognize people when they are nearby", and "Read text in normal size font in a newspaper or book", followed, in patients with AMD, by "Do things what you would like" and, in patients with DR, "Feeling frustrated by the vision problems." Regarding the treatment, the most relevant aspects for both groups is that the treatment works and receiving appropriate information before and after the treatment. The qualitative comments were focused to the disease, the treatment, and to the role of doctors and the health system. CONCLUSION: Quantitative responses and free comments can be useful to improve the care of patients with AMD or DR by physicians and the health system.

How do behavioral public policy experts see the role of complex systems perspectives? An expert interview study.

Amidst the global momentum of behavioral insights (BI), there has been a shift from mostly nudge-based BI applications to systemic approaches. This is particularly pressing in public health, where interacting issues regularly produce unanticipated consequences. Regardless, little is known about adopting complex systems approaches in behavioral public policy. This study aims to capture current practices of international BI experts on the definition, application, drivers, and hindering factors in adopting complex systems approaches in public policy. Semi-structured individual expert interviews (n = 12) of international BI experts with extensive experience in educating, cooperating with, and/or advising public servants were analyzed with inductive content analysis. While the working definition of BI aligned with published definitions, experts varied in their descriptions of complex systems approaches and its significance for public policy, including socioecological aspects, systematic BI use across policy stages, recognizing intertwined behavior, and lack of ready-made solutions. They emphasized the importance of systems approaches, identifying drivers (e.g. need for a broader focus) and hindrances (e.g. pressure for quick results). Embracing complex systems in behavioral public policy provides a holistic perspective, extending beyond simple nudges, sometimes presumed as universally applicable. While complexity perspectives would align with policymakers' worldview, applications require more work to tailor to local situations and to evaluate. Recognizing that, given their distinct expertise content, BI expertise can be quite different from complex systems expertise. The field would benefit from clear descriptions and specialized training for effective integration and advocacy for these approaches.

In recent years, the use of behavioral insights (BI) in public policy, including health policy, has been shifting from nudges to more comprehensive approaches. This study examines how international BI experts view the use of complex systems approaches in behavioral public policy. Through interviews with 12 experts advising public servants, we found that while BI definitions align with earlier published definitions, experts interpret and apply complex systems approaches differently. Some consider socioecological factors, advocate applying the systematic use of BI throughout the policy cycle, and for some using complex systems approaches means considering intertwined nature of behavioral phenomena and that there are no one-size-fits-all solutions. Experts stress the importance of a systems approach, identifying drivers (e.g. need for a broader focus, experience-based expertise) and hindering factors (e.g. advisory settings, pressure for quick results) in its implementation. This study presents BI's evolving role in public policy, highlighting the need for complex systems approaches to address multifaceted societal challenges.

A qualitative investigation of the Montgomery-Åsberg depression rating scale: discrepancies in rater perceptions and data trends in remote assessments of rapid-acting antidepressants in treatment resistant depression.

Introduction: Despite the development of many successful pharmaceutical interventions, a significant subset of patients experience treatment-resistant depression (TRD). Ketamine and its derivatives constitute a novel therapeutic approach to treat TRD; however, standard tools, such as the Montgomery-Åsberg Depression Rating Scale (MADRS) are still being used to measure symptoms and track changes. Methods: The aim of this study was to review item-level differences between rate of data change (MADRS score) and rater-weighted perception of the most useful items for assessing change in symptoms while remotely conducting the 10-item version of the MADRS in TRD in a clinical trial of rapid-acting antidepressants. Two studies of rapid-acting antidepressants in the treatment of TRD were used to identify item-scoring trends when MADRS is administered remotely and repeatedly (733 subjects across 10 visits). Scoring trends were evaluated in tandem to a rater survey completed by 75 raters. This was completed to gain insight on MADRS items' perceived level of helpfulness when assessing change of symptoms in rapid-acting antidepressant trials. Results: MADRS items 'Reduced sleep', 'Apparent sadness', and 'Pessimistic thoughts' were found to have the greatest average data change by visit, while raters ranked 'Reported sadness', 'Lassitude' and 'Apparent sadness' as the most helpful items when assessing symptom change. Discussion: The diversion between rate of data-change ranking and rater perception of helpfulness could be related to difficulty in assessing specific items, to the novel treatment itself, and/or to the sensitivity to symptom change to which raters are accustomed in traditional antidepressant treatments.

The Italian adaptation of the Mini-SIPS, a tool for early detection of individuals at clinical high risk and first episode of psychosis: A preliminary study of implementation in an Italian FEP program.

AIMS: The study aims are to present the Italian adaptation of the Abbreviated Clinical Structured Interview for DSM-5 Attenuated Psychosis Syndrome (Mini-SIPS) and illustrate its implementation in a clinical setting. METHODS: The Mini-SIPS was developed from the original extended version as a tool designed to identify, within the clinical high risk (CHR) framework, the DSM-5 Attenuated Psychosis Syndrome (APS) and to be implemented in clinical settings. The Mini-SIPS was translated in Italian by a Yale-certified SIPS trainer, then back-translated in English by a trained psychologist, then approved by the Mini-SIPS authors. Since September 2021, the adapted Italian version of the Mini-SIPS has been implemented at the First Episode Psychosis (FEP) Program in Ferrara, Italy. RESULTS: The Italian version of Mini-SIPS was successfully administered to 15 individuals subsequently referred to the First Episode Psychosis service in Ferrara. Within this sample, the tool has proven to be both an effective and efficient tool for the identification of CHR and FEP, and a valid instrument to help with the differential diagnosis. It also performed as a valuable guide for retrieving information about psychiatric history, to date the onset of APS and/or full-blown psychosis, to track the progression from CHR to psychosis or to symptoms resolution and to describe patients' pathways to care. CONCLUSION: The Mini-SIPS is an efficient and easy-to-use interview to identify the early stages of psychosis and established psychosis in clinical contexts. The Italian adaptation of this interview could be effectively implemented in other Italian FEP Programs as a screening and monitoring tool. Formal validation of the instrument is needed to assessed validity and reliability in the diagnosis of the CHR and FEP.

A qualitative inquiry to explore management of distal radius fracture by certified hand therapists.

BACKGROUND: Distal radius fractures (DRF) are extremely common in middle-aged and elderly. Certified Hand Therapists (CHT) are experts in managing hand injuries including DRF. PURPOSE: Using qualitative methodology, this study examined practice patterns among CHT and understand prevalent common patterns in managing DRF. STUDY DESIGN: Descriptive qualitative study. METHODS: This study utilized a qualitative descriptive method with an inductive approach to discern the practices of CHT in managing DRF. A purposive sample of practicing CHT was assembled. A semi-structured interview guide facilitated qualitative interviews using open-ended questions to assess practices of CHT in the domains of assessment, interventions, and appropriateness for discharge. Two student physical therapists transcribed the interviews, which were verified by a third rater for accuracy. Thematic content analysis guided the coding and analyses of the interview data. A two-phase coding process was conducted using Nvivo software. Two study authors developed initial codebook and completed subsequent analysis of transcripts. RESULTS: Of the 12 participants, five were PT and seven were OT with an average experience of 14.1 years as a CHT. Practice patterns across domains were largely consistent among CHT. All CHTs reported inquiring about severity of displacement of DRF, orthopedic management, comorbidities, and medical history as well as examining wrist/hand range of motion (ROM), grip strength (GS), and wrist functions (n = 12). A large majority administered outcome measures and performed sensory and integumentary assessment. Patient education regarding injury and exercises was the key element for interventions. Adequate gains in GS, wrist functions, wrist ROM, and ability to use wrist/hand for functional tasks were the key benchmarks for discharge from care. DISCUSSION: Most practice behaviors were common among CHTs while managing DRF. Some variations exist depending whether their primary discipline is PT or OT. The results highlight knowledge-to-action gap, where most CHTs do not integrate fall-risk management in DRF. CONCLUSIONS: This study identified common practice patterns among CHTs in managing DRF while also identifying opportunity to improve practice by integrating assessment of balance and fall-risk.

Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks.

Introduction: The goal of the Health Technology Assessment (HTA) Regulation 2021/2282 is to establish a more harmonized HTA framework, fostering member states cooperation and enabling equal patient access to innovative health technologies in Europe. This research aimed to assess the impact of the regulation on national HTAs, the strategic implications for health technology developers, and its influence on price and reimbursement negotiations. Methods: A scoping literature review encompassing peer-reviewed literature as well as grey literature was conducted. Between February and March 2023, semi-structured interviews (n = 20) were performed with stakeholders from Belgian governmental institutions, European institutions, advanced therapy medicinal product developers, academics, and sickness funds. The interviews were analyzed using the framework analysis method. Results: Numerous steps, such as the development of implementing acts and procedural guidelines remain to be taken. At member state level, national/regional HTA bodies and payers must act to adopt the new concepts of Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) within their national legislation, as well as revise their timelines and prepare for interactions at a European level. Compiling a harmonized PICO (Population, Intervention, Comparator, and Outcome), adapting local procedures, and increasing capacity to actively take part in the JSC and JCA are seen as primary barriers by several stakeholders. Training and education will help HTA bodies, payers, and health technology developers to participate in the European processes. Conclusion: While practical and legal challenges were identified, recommendations (such as actively preparing for the upcoming changes and increasing capacity while providing training) were provided to adapt national and European procedures to the needs of the HTA Regulation 2021/2282. The importance of fostering collaborations and aligning local HTA procedures with the new way of working set out by the Regulation was demonstrated with this study.

Oral Chinese Herbal Medicine plus usual care for diabetic kidney disease: study protocol for a randomized, double-blind, placebo-controlled pilot trial.

Background: Diabetic kidney disease (DKD) has become the leading cause of kidney failure, causing a significant socioeconomic burden worldwide. The usual care for DKD fails to achieve satisfactory effects in delaying the persistent loss of renal function. A Chinese herbal medicine, Tangshen Qushi Formula (TQF), showed preliminary clinical benefits with a sound safety profile for people with stage 2-4 DKD. We present the protocol of an ongoing clinical trial investigating the feasibility, efficacy, and safety of TQF compared to placebo in delaying the progressive decline of renal function for people with stage 2-4 DKD. Methods: A mixed methods research design will be used in this study. A randomized, double-blind, placebo-controlled pilot trial will evaluate the feasibility, efficacy, and safety of TQF compared to placebo on kidney function for people with stage 2-4 DKD. An embedded semi-structured interview will explore the acceptability of TQF granules and trial procedures from the participant's perspective. Sixty eligible participants with stage 2-4 DKD will be randomly allocated to the treatment group (TQF plus usual care) or the control group (TQF placebo plus usual care) at a 1:1 ratio for 48-week treatment and 12-week follow-up. Participants will be assessed every 12 weeks. The feasibility will be assessed as the primary outcome. The changes in the estimated glomerular filtration rate, urinary protein/albumin, renal function, glycemic and lipid markers, renal composite endpoint events, and dampness syndrome of Chinese medicine will be assessed as the efficacy outcomes. Safety outcomes such as liver function, serum potassium, and adverse events will also be evaluated. The data and safety monitoring board will be responsible for the participants' benefits, the data's credibility, and the results' validity. The intent-to-treat and per-protocol analysis will be performed as the primary statistical strategy. Discussion: Conducting a rigorously designed pilot trial will be a significant step toward establishing the feasibility and acceptability of TQF and trial design. The study will also provide critical information for future full-scale trial design to further generate new evidence supporting clinical practice for people with stage 2-4 DKD. Trial registration number: https://www.chictr.org.cn/, identifier ChiCTR2200062786.