Evaluation of different substance combinations in a multiple-session mesotherapy protocol for the management of osteoarthritis in dogs: a retrospective study.

OBJECTIVE: To describe the effect of different substance combinations administered through mesotherapy in dogs with hip osteoarthritis. ANIMALS: 104 dogs. METHODS: In this retrospective study, 4 groups (dogs treated with a combination of lidocaine, piroxicam, and thiocolchicoside [MG]; dogs treated with lidocaine, piroxicam, and Traumeel [TG]; dogs treated with lidocaine, piroxicam, and glucosamine [GG]; and dogs treated with the same combination as in MG combined with a photobiomodulation session [MPG]) were set. For all groups, the same treatment frequency was followed. Response to treatment was measured with the Canine Brief Pain Inventory (divided into pain interference score and pain severity score), Liverpool Osteoarthritis in Dogs (LOAD), and Canine Orthopedic Index (divided into function, gait, stiffness, and quality of life) before treatment and 15, 30, 60, 90, and 120 days after treatment. Cox proportional hazard regression analysis was used to investigate the influence of treatment, age, sex, body weight, breed, and Orthopedic Foundation for Animals score. RESULTS: Dogs had a mean age of 7.6 ± 3.1 years and body weight of 28.6 ± 5.5 kg. Hip osteoarthritis was classified as mild (4), moderate (70), or severe (30). Greater improvements were observed in MG and MPG. Kaplan-Meier estimators showed MG and MPG had longer periods with clinically significant results. Treatment was the covariable that contributed more frequently to the outcomes observed. CLINICAL RELEVANCE: The combination used in MG, particularly combined with photobiomodulation, produced longer-lasting clinically significant results.

Risk Factors and Patient-Reported Outcomes in Chinese Women with Postpartum Diastasis Recti Abdominis: An Observational Study.

Purpose: Diastasis recti abdominis (DRA) is a condition in which the linea alba is stretched and widened, and the abdominal muscles are separated from each other. DRA typically occurs in pregnant and postpartum women. We aimed to determine the risk factors and patient-reported outcomes (PROs) of DRA in Chinese postpartum women. Methods: This observational study was conducted in Hangzhou Hospital of Traditional Chinese Medicine, and involved 534 women who filled out the following risk-factor and PRO questionnaires: SF-MPQ-2, SF-ICIQ, LDQ, EPDS, MBIS, HerQles, and SF-36 (all Chinese versions). The inter-recti distance was measured by palpation. Statistical analyses were performed using SPSS v25.0 software and the Mann-Whitney U-test, chi-square test, binary logistic regression analysis (for risk factors of DRA), and the Kendall and Spearman tests (for correlation analysis). Results: After childbirth, 78.1% (417/534) of the enrolled women had DRA. Abdominal surgery (P = 0.002), number of pregnancies (P = 0.035), parity (P = 0.012), number of births (P = 0.02), fetal birth weight (P = 0.014), and waist-to-hip ratio in the supine position (P = 0.045) significantly differed between the DRA and non-DRA groups. Caesarean delivery was an independent risk factor for DRA. The PROs were significantly worse in the DRA group than in the non-DRA group. Conclusion: Caesarean delivery was an independent risk factor for DRA. Women with DRA are more likely to have limited physical activity or function after childbirth, lower self-confidence, and a decreased quality of life.

Reporting and influencing factors of patient-reported outcomes in acupuncture randomised controlled trials: a cross-sectional study protocol.

INTRODUCTION: Patient-reported outcomes (PROs) are health reports that come directly from the patients themselves and represented the experience and insights of the patient's perspective on the impact of the intervention. PROs were increasingly emphasised in acupuncture randomised controlled trials (RCTs). However, the reporting quality of PROs in acupuncture RCTs has not been investigated to date. Therefore, we constructed this study to reveal the basic characteristics and reporting quality of PROs in acupuncture RCTs, and explore the relationship between concealment, blinding and RROs. We hope our findings can provide guidance for the reporting standards and future development of PROs in acupuncture RCTs in reverse. METHODS AND ANALYSIS: RCTs using acupuncture treatment as the intervention and PROs as primary outcomes or secondary outcomes will be systematically searched through seven databases MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP between 1 January 2012 and 15 October 2022. The basic characteristics, concealment, blinding design and the characteristics of PROs in included RCTs will be summarised. The reporting quality of PROs will be assessed based on the CONSORT PRO extension. Logistic analysis will be performed to identify the association between concealment, blinding and RROs. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. This protocol has been registered in Open Science Framework (OSF) Registries. The findings of this study will be submitted to a peer-reviewed academic journal.

A threshold of lower preoperative mental health is associated with decreased achievement of comfort and capability benchmarks following rotator cuff repair: a retrospective cohort study.

BACKGROUND: Preoperative biomedical patient characteristics are known to affect the time to achievement of clinically significant outcomes (CSOs) following arthroscopic rotator cuff repair (RCR). However, less is known about the association between preoperative mental status and the time to achievement of CSOs. We hypothesize that higher preoperative mental status is associated with faster achievement of CSOs following arthroscopic RCR. METHODS: Patient-reported outcome measures (PROMs) were collected preoperatively and at postoperative intervals up to 2 years. PROMs included pain visual analog scale (VAS), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Single Assessment Numeric Evaluation (SANE), and Veterans RAND 12-Item Health Survey (VR-12) scores. Threshold values for CSOs were obtained from previous literature. Mean time to achievement of CSOs was calculated using a Kaplan-Meier analysis. A Cox proportional hazards regression analysis was performed to identify preoperative variables associated with earlier achievement of CSOs. RESULTS: Sixty-nine patients with an average age of 59 ± 8 years were included. Patients with higher preoperative mental status, as measured by VR-12 mental component summary (MCS), experienced significantly earlier substantial pain improvement postoperatively (P = .0471). Patients with higher preoperative mental status also achieved CSOs for physical health at earlier time points (P = .0187). Preoperative VR-12 MCS scores ≥ 40 were associated with earlier achievement of CSOs for pain (P = .0005) and physical health (P = .0015). Ninety-eight percent of patients with preoperative MCS scores ≥40 achieved acceptable pain relief at 4.5 months vs. 56% of all other patients at 12.3 months (P = .0001). Patients with preoperative MCS scores ≥40 experienced significantly faster improvement in physical health compared to patients with preoperative MCS scores <40 (P = .0006). CONCLUSIONS: Higher preoperative mental status, especially a preoperative MCS score ≥40, is associated with significantly faster improvement in pain and physical function following arthroscopic RCR. Nearly all patients (98%) with preoperative MCS score ≥40 achieved an acceptable state of pain relief compared with only 56% of patients with preoperative MCS score <40. These findings indicate that a holistic approach with equal consideration of preoperative mental health and rotator cuff pathophysiology is vital to the successful management of rotator cuff tendinopathy.

Effectiveness of trauma-focused art therapy (TFAT) for psychological trauma: study protocol of a multiple-baseline single-case experimental design.

INTRODUCTION: Treatments such as eye movement desensitisation and reprocessing and (narrative) exposure therapies are commonly used in psychological trauma. In everyday practice, art therapy is also often used, although rigorous research on its efficacy is lacking. Patients seem to benefit from the indirect, non-verbal experiential approach of art therapy. This protocol paper describes a study to examine the effectiveness of a 10-week individual trauma-focused art therapy (TFAT) intervention. METHODS AND ANALYSIS: A mixed-methods multiple-baseline single-case experimental design will be conducted with 25-30 participants with psychological trauma. Participants will be randomly assigned to a baseline period lasting 3-5 weeks, followed by the TFAT intervention (10 weeks) and follow-up (3 weeks). Quantitative measures will be completed weekly: the Beck Depression Inventory-II, the Mental Health Continuum Short Form, the Resilience Scale, the Rosenberg Self-Esteem Scale and the Self-expression and Emotion Regulation in Art Therapy Scale. The Post-Traumatic Stress Disorder Checklist-5 will be completed at week 1 and week 10. Qualitative instruments comprise a semistructured interview with each individual patient and therapist, and a short evaluation for the referrer. Artwork will be used to illustrate the narrative findings. Quantitative outcomes will be analysed with linear mixed models using the MultiSCED web application. Qualitative analyses will be performed using thematic analysis with ATLAS.ti. ETHICS AND DISSEMINATION: This study has been approved by the ethics committee of the HAN University of Applied Sciences (ECO 394.0922). All participants will sign an informed consent form and data will be treated confidentially. Findings will be published open access in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05593302.

Psychometric properties of the living with long term conditions scale in an English-speaking population living with long term conditions in the UK.

OBJECTIVE: To present the psychometric properties of the living with long-term condition (LwLTCs) scale in an English-speaking population of people with different LTCs. DESIGN: An observational and cross-sectional study, with retest was conducted. Psychometric properties including feasibility, internal consistency, confirmatory factor analysis, reproducibility and content validity were tested. SETTING: The study took place across the UK via primary care surgeries and voluntary organisations, between December 2021 and June 2022. PARTICIPANTS: The study included 577 patients living with different LTCs, as chronic obstructive pulmonary disease, arthritis, chronic heart failure, Parkinson's disease, chronic kidney disease and type 2 diabetes mellitus. Inclusion criteria included: (a) having been diagnosed with one or more of the conditions; (b) being able to read, understand and answer written questionnaires; (c) being fluent in English and (d) being able to provide written informed consent. Patients were involved in the design and pilot study of the scale. RESULTS: A total sample of 577 people with an age range of 37-97 years (98±9.65) were recruited. Internal consistency of the total 26-item LwLTCs scale score was excellent (ordinal alpha=0.90) but confirmatory factor analysis showed better fit indices (Normed Fit Index=0.96; standardised root mean square residual=0.051; Goodness of Fit Index=0.98) for a 20-item LwLTCs scale. CONCLUSIONS: A shorter version of the LwLTCs scale, with just 20 items and with excellent psychometric properties, is recommended. Having a short scale is key when considering the implementation of the scale in clinical practice to develop person-centred pathways and more comprehensive care plans.

Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial.

BACKGROUND: Endometriosis-related pain encompassing dysmenorrhea, dyspareunia, and chronic pelvic pain, reduces the quality of life in premenopausal women. Although treatment options for endometriosis alleviate this pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. The Angel Touch device (AT-04) is a portable magnetic fields irradiation device that incorporates a combination of mixed alternative magnetic fields at 2 kHz and 83.3 MHz. A phase III trial confirmed the efficacy and safety of AT-02, a prototype of AT-04, for pain relief in patients with fibromyalgia. METHODS: This is a phase III, multicenter, prospective, randomized, sham device-controlled, double-blind, parallel study. The participants will be premenopausal women aged > 18 years who have endometriosis-related pain with at least moderate severity. Considering dropouts, 50 participants have been deemed appropriate. Eligible women will be centrally registered, and the data center will randomly allocate them in a 1:1 ratio to the intervention and control groups. Women in the intervention group will receive electromagnetic wave irradiation generated by AT-04 and those who in the control group will wear a sham device for 16 weeks, and both groups will wear AT-04 for another 4 weeks. The primary outcome measure is the change in the Numeric Rating Scale score at 16 weeks compared with the baseline. Secondary outcome measures are efficacy for pelvic pain including dysmenorrhea and non-menstrual pain, and chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia, and improvement of quality of life during the study period. Safety will be evaluated by device defects and the frequency of adverse events. The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act and relevant notifications. DISCUSSION: This study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age. Trial registration number Japan Registry of Clinical Trials (jRCTs032230278).

Endometriosis is a chronic inflammatory disorder that negatively impacts reproductive health via endometriosis-related pain, infertility, and endometriosis-associated ovarian cancer. Although current therapeutic options for endometriosis are effective for the endometriosis-related pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. This is the first randomized controlled trial to investigate the efficacy and safety of a novel portable pain management device, AT-04, that incorporates a combination of mixed alternating magnetic fields, for endometriosis-related pain. This is a multicenter, prospective, sham device-controlled, double-blind, parallel study. Enrolled women will have undergone standard hormonal treatment for endometriosis at baseline, and this allows for assessing whether the device remains effective when used in conjunction with existing treatment methods. The study also will explore the impact of AT-04 on reducing the size of ovarian endometriotic cysts that reflect the activity of endometriosis. The study reflects the strong desire by physicians to liberate women from the unbearable pain associated with endometriosis. The sole efficacy of AT-04 in treating endometriosis-related pain is difficult to evaluate as there is a possibility that menstrual cycles may influence the assessment of pain and quality of life. However, the study findings regarding the effectiveness of AT-04 for the treatment of endometriosis-related pain may benefit women with endometriosis who have pain that is not effectively relieved by other treatments. Consequently, it may contribute to the improvement of reproductive health within society.

Holistic burden of illness in patients with endogenous Cushing's syndrome: A systematic literature review.

OBJECTIVE: The objective of this systematic literature review (SLR) was to summarize the latest studies evaluating the burden of illness in endogenous Cushing's syndrome (CS), including the impact of CS on overall and domain-specific health-related quality of life (HRQoL) and the economic burden of CS to provide a holistic understanding of disease and treatment burden. METHODS: An SLR was conducted in PubMed, MEDLINE and Embase using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist to identify peer-reviewed manuscripts and conference abstracts published in English from 2015 to December 4, 2020. RESULTS: Forty-five publications were eligible for inclusion; data were extracted from 37 primary studies while 8 SLRs were included for reference only. Thirty-one studies reported HRQoL using validated patient reported outcome (PRO) measures in pre- or post-surgery, radiotherapy and pharmacotherapy patients. Overall, this SLR found that patients with CS have worse outcomes relative to healthy populations across specific dimensions, such as depression, despite an improvement in HRQoL post-treatment. These findings reveal that CS symptoms are not fully resolved by the existing care paradigm. Few studies report on the economic burden of CS and currently available data indicate a high direct healthcare system cost burden. CONCLUSIONS: Patients with CS experience a significant, complex and multifactorial HRQoL burden. Symptom-specific burden studies are sparse in the literature and the understanding of long-term CS symptomatic burden and economic burden is limited. This review intends to provide an updated reference for clinicians, payers and other stakeholders on the burden of CS as reported in published literature and to encourage further research in this area.

Healing beyond the joint: Addressing mental health in periprosthetic joint infection in a prospective longitudinal study.

OBJECTIVE: Periprosthetic joint infection (PJI) is a devastating complication following joint replacement surgeries. While the somatic impacts of PJI have been extensively explored, the influence on mental health remains understudied. This study aimed to longitudinally assess the psychological burden, quality of life, and expectations in individuals undergoing treatment for PJI. METHODS: A prospective study was conducted at a German trauma center between January 2020 and December 2022. Patients diagnosed with PJI (n = 29, mean age 71.4 ± 8.8 years) were assessed at five timepoints, within one week before revision surgery, one month, three, six, and twelve months postoperatively. Outcomes included the ICD-10 symptom-rating (ISR), German Short-Form 36 (SF-36), European Quality of Life 5 Dimensions (EQ-5D), and an expectation questionnaire. RESULTS: Psychological scores exhibited significant upward trends over time. The ISR score increased from 0.55 preoperatively to 0.87 at the 12-month follow-up (p = 0.002), surpassing the clinically relevant threshold. Depression and anxiety scores peaked at 6 months (1.6, p = 0.005) and 12 months (1.12, p = 0.001), respectively. Quality of life, measured by SF-36, showed stable physical component summary scores but declining mental component summary scores. Patients' expectations of returning to normal health consistently decreased (p = 0.009). CONCLUSION: Patients undergoing treatment for PJI experience significant psychological burden, with implications for quality of life and expectations of recovery. The findings underscore the importance of addressing psychological well-being in the management of PJI and emphasize the need for comprehensive care strategies that encompass both somatic and psychological dimensions.

Development of CORE-CM core outcome domain sets for trials of Chinese medicine for lumbar spinal stenosis.

OBJECTIVES: Most Asian countries have employed Chinese medicine (CM) and Western medicine to treat lumbar spinal stenosis (LSS). Evidence synthesis and comparison of effectiveness are difficult since outcomes examined and presented through trials possess heterogeneity. This study aimed to solve the outcome problems for CM clinical trials in LSS by building a core outcome set (COS). METHODS: To achieve an agreement on a set of core outcome domains, a four-phase study was carried out. First, we identified candidate outcome domains by systematically reviewing trials. In addition, we identified outcome domains associated with patients by conducting semistructured interviews with patients. Next, outcome domains were processed through a national two-round Delphi survey, in which 18 patients and 21 experts were recruited. Finally, the above domains were converted as a core outcome domain set based on a consensus meeting, in which 24 stakeholders were recruited. RESULTS: Seventeen outcome subdomains were identified by the systematic review and interviews. The Delphi survey assigned a priority to four outcome domains in the first round and four outcomes additionally in the second round. The core outcome domains were determined through discussion and redefinition of outcomes in the consensus meeting: pain and discomfort, health-related quality of life, lumbar function, activities of daily living, measures of walking, patient global assessment, adverse events and CM-specific outcomes. CONCLUSION: COS-CM-LSS is likely to enhance the consistency of outcomes reported in clinical trials. In-depth research should be conducted for the exploration of the best methods to examine the above outcomes.

A descriptive analysis of the contents of Care Response, an international data set of patient-reported outcomes for chiropractic patients.

BACKGROUND: Databases have become an important tool in understanding trends and correlations in health care by collecting demographic and clinical information. Analysis of data collected from large cohorts of patients can have the potential to generate insights into factors identifying treatments and the characteristics of subgroups of patients who respond to certain types of care. The Care Response (CR) database was designed to capture patient-reported outcome measures (PROMs) for chiropractic patients internationally. Although several papers have been published analysing some of the data, its contents have not yet been comprehensively documented. The primary aim of this study was to describe the information in the CR database. The secondary aim was to determine whether there was suitable information available to better understand subgroups of chiropractic patients and responsiveness to care. This would be achieved by enabling correlations among patient demographics, diagnoses, and therapeutic interventions with machine learning approaches. METHODS: Data in all available fields were requested with no date restriction. Data were collected on 12 April 2022. The output was manually scanned for scope and completeness. Tables were created with categories of information. Descriptive statistics were applied. RESULTS: The CR database collects information from patients at the first clinical visit, 14, 30, and 90 days subsequently. There were 32,468 patient responses; 3210 patients completed all fields through the 90 day follow up period. 45% of respondents were male; 54% were female; the average age was 49. There was little demographic information, and no information on diagnoses or therapeutic interventions. We received StartBack, numerical pain scale, patient global impression of change, and Bournemouth questionnaire data, but no other PROMs. CONCLUSIONS: The CR database is a large set of PROMs for chiropractic patients internationally. We found it unsuitable for machine learning analysis for our purposes; its utility is limited by a lack of demographic information, diagnoses, and therapeutic interventions. However, it can offer information about chiropractic care in general and patient satisfaction. It could form the basis for a useful clinical tool in the future, if reformed to be more accessible to researchers and expanded with more information collected.

Systematic literature review informing the EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus and systemic sclerosis.

Through this systematic literature review, we assembled evidence to inform the EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). We screened articles published between January 2000 and June 2021. Studies selected for data extraction (118 for SLE and 92 for SSc) were thematically categorised by the character of their intervention. Of 208 articles included, 51 were classified as robust in critical appraisal. Physical activity was the most studied management strategy and was found to be efficacious in both diseases. Patient education and self-management also constituted widely studied topics. Many studies on SLE found psychological interventions to improve quality of life. Studies on SSc found phototherapy and laser treatment to improve cutaneous disease manifestations. In summary, non-pharmacological management of SLE and SSc encompasses a wide range of interventions, which can be combined and provided either with or without adjunct pharmacological treatment but should not aim to substitute the latter when this is deemed required. While some management strategies i.e., physical exercise and patient education, are already established in current clinical practice in several centres, others e.g., phototherapy and laser treatment, show both feasibility and efficacy, yet require testing in more rigorous trials than those hitherto conducted.

Identification of the Needs and Preferences of Patients With Cancer for the Development of a Clinic App: Qualitative Study.

BACKGROUND: Mobile health (mHealth) tools were developed during the past decades and are increasingly used by patients in cancer care too. Scientific research in the development of mHealth services is required in order to meet the various needs of patients and test usability. OBJECTIVE: The aim of this study is to assess patients' needs, preferences, and usability of an app (My University Clinic [MUC] app) developed by the Comprehensive Cancer Center Freiburg (CCCF) Germany. METHODS: Based on a qualitative cross-sectional approach, we conducted semistructured interviews with patients with cancer, addressing their needs, preferences, and usability of the designed MUC app. Patients treated by the CCCF were recruited based on a purposive sampling technique focusing on age, sex, cancer diagnoses, and treatment setting (inpatient, outpatient). Data analysis followed the qualitative content analysis according to Kuckartz and was performed using computer-assisted software (MAXQDA). RESULTS: For the interviews, 17 patients with cancer were selected, covering a broad range of sampling parameters. The results showed that patients expect benefits in terms of improved information about the disease and communication with the clinic staff. Demands for additional features were identified (eg, a list of contact persons and medication management). The most important concerns referred to data security and the potential restriction of personal contacts with health care professionals of the clinical departments of the CCCF. In addition, some features for improving the design of the MUC app with respect to usability or for inclusion of interacting tools were suggested by the patients. CONCLUSIONS: The results of this qualitative study were discussed within the multidisciplinary team and the MUC app providers. Patients' perspectives and needs will be included in further development of the MUC app. There will be a second study phase in which patients will receive a test version of the MUC app and will be asked about their experiences with it. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00022162; https://drks.de/search/de/trial/DRKS00022162.

Uptake of pediatric patient-reported outcome and experience measures and challenges associated with their implementation in Alberta: a mixed-methods study.

BACKGROUND: Implementing Patient-reported Outcome Measures (PROMs) and Patient-reported Experience Measures (PREMs) is an effective way to deliver patient- and family-centered care (PFCC). Although Alberta Health Services (AHS) is Canada's largest and fully integrated health system, PROMs and PREMs are yet to be routinely integrated into the pediatric healthcare system. This study addresses this gap by investigating the current uptake, barriers, and enablers for integrating PROMs and PREMs in Alberta's pediatric healthcare system. METHODS: Pediatric clinicians and academic researchers with experience using PROMs and PREMs were invited to complete a quantitative survey. Additionally, key stakeholders were qualitatively interviewed to understand current challenges in implementing pediatric PROMs and PREMs within AHS. Quantitative data gathered from 22 participants were descriptively analyzed, and qualitative data from 14 participants were thematically analyzed. RESULTS: Participants identified 33 PROMs and 6 PREMs showing diversity in the types of pediatric PROMs and PREMs currently being used in Alberta and their mode of administration. The qualitatively identified challenges were associated with patients, family caregivers, and clinicians. The absence of system-level support, such as integration within electronic medical records, is considered a significant system-level challenge. CONCLUSIONS: The significant variation in the types of PROMs and PREMs used, the rationale for their use, and their mode of administration demonstrate the diverse and sporadic use of these measures in Alberta. These findings highlight the need for province-wide uniform implementation of pediatric PROMs and PREMs in Alberta. Our results could benefit healthcare organizations in developing evidence-based PROM and PREM implementation strategies in pediatrics.

Acceptability of the routine use and collection of a generic patient reported outcome measure from the perspective of healthcare staff: a qualitative study.

BACKGROUND: Patient-reported outcome measures (PROMs) provide a measure of self-perceived health status or health-related quality of life. They have been used to support provider-patient decisions, healthcare delivery, and value-based healthcare models. A barrier to routine collection of PROMs is the perception that PROMs lack clinical utility. As such, it is important to establish clinicians' acceptability of the PROM prior to large-scale implementation. This study explored the acceptability of the routine use and collection of a generic PROM in healthcare services from the perspective of healthcare staff. METHODS: Individual semi-structured interviews were completed from September 2020 to March 2021 with 26 staff from two multi-disciplinary community healthcare services in Melbourne, Australia. Interviews explored their experiences of using the EQ-5D-5L in their routine care. Interviews were recorded and transcribed verbatim. Data were analysed according to a framework approach, using inductive and deductive techniques. RESULTS: Participants discussed the acceptability of the EQ-5D-5L with reference to four themes: practicalities of use; holistic nature; influence on client care; and influence on health service. Participants found the EQ-5D-5L quick and easy to administer, and appreciated that it measured multiple domains of health that were relevant to their clients' care. They believed the EQ-5D-5L helped to identify client problems, and inform service delivery. They also reported features that were less acceptable, including a lack of item specificity to some healthcare disciplines. Participants reported the challenge of managing conflict between their assessment of the client's health and the client's perspective of their own health, leading some to question whether the client could provide an accurate reflection of their own health. CONCLUSIONS: The EQ-5D-5L has several features that healthcare staff viewed as acceptable for routine collection and use in healthcare. Training on the validity of the patient reported perspective and broadening the scope of PROMs collection beyond the EQ-5D-5L should be considered to facilitate large-scale implementation.

Patient-Reported Outcome Measures in Liver and Gastrointestinal Cancer Randomized Controlled Trials.

OBJECTIVE: For many years, outcomes such as mortality and morbidity were the standard for evaluating oncological treatment effectiveness. With the introduction of patient-reported outcome measures (PROMs), the focus shifted from a mere extension of a patient's life or release from disease to the improvement of a multilayered concept of health, decisively affecting life satisfaction. In this study, we deal with the topic of PROMs in liver and gastrointestinal randomized controlled trials. RESULTS: The final database included 43 papers reporting results of randomized controlled trials (RCTs) for liver or gastrointestinal cancer interventions where one of the primary or secondary outcomes was a health-related quality of life measure. The most often used PROM was the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) for both liver cancer and gastrointestinal cancer (in 62% of gastrointestinal cancer studies and 57% of liver cancer studies). For the gastrointestinal cancer group, the QLQ-STO22, a cancer-specific extension of the QLQ-C30, was the second most commonly used PROM. In liver cancer, the generic PROM Short Form 36 and the EORTC QLQ-HCC18, a cancer-specific extension of the QLQ-C30, were the second most commonly used PROMs. CONCLUSION: We found that RCTs often do not include comprehensive quality-of-life measures. When quality of life is part of an RCT, it is often only a secondary outcome. For a holistic view of the patient, a stronger integration and weighting of patient-reported outcomes in RCTs would be desirable.

Understanding the patient experience and treatment benefits in patients with non-small-cell lung cancer with brain metastasis.

BACKGROUND: Despite the high prevalence of brain metastases (BM) secondary to non-small-cell lung cancer (NSCLC) (NSCLC/BM), patients' experiences (symptoms and impacts) are not fully understood. This study sought to understand the patient experience with NSCLC/BM and identify a patient-reported outcome (PRO) measure fit to capture the most important NSCLC/BM symptoms and impacts. METHODS: A targeted literature review was completed; the National Comprehensive Cancer Network (NCCN)/Functional Assessment of Cancer Therapy-Brain Symptom Index, 24-item version (NFBrSI-24) was identified as a relevant measure that assessed the core symptoms and impacts associated with NSCLC/BM. Qualitative interviews composed of concept elicitation and cognitive debriefing with oncologists (n = 3) and adult patients (n = 16) with NSCLC/BM were conducted to confirm the content validity and evaluate the relevance and appropriateness of the NFBrSI-24 for this condition. RESULTS: The NSCLC/BM symptoms and impacts identified in the literature and reported by oncologists and patients were consistent and captured in the NFBrSI-24. Study participants reported significant burden associated with the symptoms (commonly fatigue, headache) and impacts of NSCLC/BM. Participants indicated that the NFBrSI-24 captured their most salient experiences with NSCLC/BM and that symptom improvement or a delay in progression, as measured by the NFBrSI-24, would be meaningful. During the cognitive debriefing, participants generally indicated that the NFBrSI-24 was comprehensive and easy to understand/answer and that it assessed symptoms they considered most important to treat. CONCLUSIONS: These results suggest that the NFBrSI-24 adequately captures an appropriate measure of NSCLC/BM symptoms and impact.

Quality of life and satisfaction of patients after oncoplastic or traditional breast-conserving surgery using the BREAST-Q (BCT module): a prospective study.

INTRODUCTION: The oncoplastic conservative surgery was developed as a natural evolution of traditional surgery, attempting to improve the therapeutic and aesthetic outcomes where tumor resection could be followed by not-adequate results. Our primary aim is to evaluate how patient satisfaction and quality-of-life after conservative oncoplastic surgery, using BREAST-Q (BCT Module), change pre- and post-operatively. The secondary aim is to compare patient-reported outcome after oncoplastic or traditional conservative surgery. PATIENTS AND METHODS: We enrolled 647 patients who underwent traditional conservative surgery or oncoplastic surgery from January 2020 to December 2022. Only 232 women (35.9%) completed the BREAST-Q questionnaire on a web-based platform, at the preoperative phase and 3 months after treatment. RESULTS: The average score of "Psychosocial well-being" and "Satisfaction with Breasts" 3 months after surgery showed a statistically significant improvement, while the average score for "Physical well-being: Chest" at 3 months showed a worsening compared to the baseline. "Sexual well-being" did not show statistically significant change. A significant difference between the post-operative outcome of oncoplastic surgery and traditional surgery was observed only for Physical well-being (better for traditional surgery). CONCLUSIONS: The study showed significant improvement in patient-reported outcomes 3 months after the surgery, except for physical discomfort that increases especially after oncoplastic surgery. Furthermore, our data, as well as many others, point to the appropriateness of using OCS where there is an effective indication, while the perspective of patients cannot find significant superiority over TCS in any of the areas analyzed.

Narrow-diameter versus regular-diameter dental implants for mandibular overdentures: A systematic review and meta-analysis.

PURPOSE: The aim of this systematic review was to compare treatment outcomes in terms of implant survival rate, marginal bone loss, and patient-reported outcome measures (PROMs) between narrow-diameter implants and regular-diameter implants (RDIs) for mandibular implant overdentures (MIOs). METHODS: This study was based on the methodology adapted as per Cochrane. Medline, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and Scopus were searched for pertinent studies published by July 22, 2022. Outcome parameters included in this meta-analysis were implant survival rate, marginal bone loss, visual analogue scale score for patient satisfaction, and value of oral health impact profile. RESULTS: A total of 782 non-duplicate articles and 83 clinical study registrations were identified from database and hand searches, of which 26 were eligible for full-text searches. Finally, 12 publications reporting on 8 independent studies were included in this review. In the meta-analysis, implant survival rate and marginal bone loss did not significantly differ between narrow-diameter implants and RDIs. Regarding RDIs, narrow-diameter implants were associated with significantly better outcomes in general patient satisfaction and oral health-related quality of life than RDIs for mandibular overdentures. CONCLUSIONS: Narrow-diameter implants have competitive treatment outcomes compared to RDIs in terms of implant survival rate, marginal bone loss, and PROMs. [Correction added on July 21, 2023, after first online publication: The abbreviation RDIs was changed to PROMs in the preceding sentence.] Thus, narrow-diameter implants might be an alternative treatment option for MIOs in situations with limited alveolar bone volume.

A comparison of machine learning models for predicting urinary incontinence in men with localized prostate cancer.

Introduction: Urinary incontinence (UI) is a common side effect of prostate cancer treatment, but in clinical practice, it is difficult to predict. Machine learning (ML) models have shown promising results in predicting outcomes, yet the lack of transparency in complex models known as "black-box" has made clinicians wary of relying on them in sensitive decisions. Therefore, finding a balance between accuracy and explainability is crucial for the implementation of ML models. The aim of this study was to employ three different ML classifiers to predict the probability of experiencing UI in men with localized prostate cancer 1-year and 2-year after treatment and compare their accuracy and explainability. Methods: We used the ProZIB dataset from the Netherlands Comprehensive Cancer Organization (Integraal Kankercentrum Nederland; IKNL) which contained clinical, demographic, and PROM data of 964 patients from 65 Dutch hospitals. Logistic Regression (LR), Random Forest (RF), and Support Vector Machine (SVM) algorithms were applied to predict (in)continence after prostate cancer treatment. Results: All models have been externally validated according to the TRIPOD Type 3 guidelines and their performance was assessed by accuracy, sensitivity, specificity, and AUC. While all three models demonstrated similar performance, LR showed slightly better accuracy than RF and SVM in predicting the risk of UI one year after prostate cancer treatment, achieving an accuracy of 0.75, a sensitivity of 0.82, and an AUC of 0.79. All models for the 2-year outcome performed poorly in the validation set, with an accuracy of 0.6 for LR, 0.65 for RF, and 0.54 for SVM. Conclusion: The outcomes of our study demonstrate the promise of using non-black box models, such as LR, to assist clinicians in recognizing high-risk patients and making informed treatment choices. The coefficients of the LR model show the importance of each feature in predicting results, and the generated nomogram provides an accessible illustration of how each feature impacts the predicted outcome. Additionally, the model's simplicity and interpretability make it a more appropriate option in scenarios where comprehending the model's predictions is essential.