Validation of the Optimal University of California Los Angeles Loneliness Scale Cutoff Score in Screening for the Prevention of Disability Occurrence Among Older Japanese Adults.

OBJECTIVES: The association between loneliness and disability is a growing public health priority. While the University of California Los Angeles Loneliness Scale (UCLA-LS) has been internationally used as an indicator for assessing loneliness, its optimal cutoff point in relation to disability occurrence has not yet been examined. Therefore, we aimed to determine the optimal cutoff point of the UCLA-LS regarding future disability. METHODS: This longitudinal cohort study was conducted in Tokai City, Aichi Prefecture, Japan. Overall, 4536 community-dwelling older adults (age: 73.8 ± 5.5 years; females: 55.2%) were followed up for 2 years. The area under the curve of the receiver operating characteristic analysis was calculated to evaluate the optimal cutoff point of the UCLA-LS in relation to future disability occurrence using the Youden index, which maximized the sensitivity and specificity of the UCLAS-LS. A survival analysis was conducted to test this cutoff value's external validity, using the presence or absence of disability occurrence as the dependent variable. RESULTS: The cutoff score of the UCLA-LS in relation to future disability was 44 points. An association was found between new disability occurrence and loneliness based on this cutoff value (hazard ratio: 1.67, 95% confidence interval: 1.29-2.16). CONCLUSIONS: Although cultural context should be taken into account, the optimal cutoff scores for the loneliness scale related to disability identified in this study may be a useful indicator for early recognition of loneliness as a global public health problem and for promoting social participation as one of the disability prevention strategies.

Utility of RAND/UCLA appropriateness method in validating multiple-choice questions on ECG.

OBJECTIVES: This study aimed to investigate the utility of the RAND/UCLA appropriateness method (RAM) in validating expert consensus-based multiple-choice questions (MCQs) on electrocardiogram (ECG). METHODS: According to the RAM user's manual, nine panelists comprising various experts who routinely handle ECGs were asked to reach a consensus in three phases: a preparatory phase (round 0), an online test phase (round 1), and a face-to-face expert panel meeting (round 2). In round 0, the objectives and future timeline of the study were elucidated to the nine expert panelists with a summary of relevant literature. In round 1, 100 ECG questions prepared by two skilled cardiologists were answered, and the success rate was calculated by dividing the number of correct answers by 9. Furthermore, the questions were stratified into "Appropriate," "Discussion," or "Inappropriate" according to the median score and interquartile range (IQR) of appropriateness rating by nine panelists. In round 2, the validity of the 100 ECG questions was discussed in an expert panel meeting according to the results of round 1 and finally reassessed as "Appropriate," "Candidate," "Revision," and "Defer." RESULTS: In round 1 results, the average success rate of the nine experts was 0.89. Using the median score and IQR, 54 questions were classified as " Discussion." In the expert panel meeting in round 2, 23% of the original 100 questions was ultimately deemed inappropriate, although they had been prepared by two skilled cardiologists. Most of the 46 questions categorized as "Appropriate" using the median score and IQR in round 1 were considered "Appropriate" even after round 2 (44/46, 95.7%). CONCLUSIONS: The use of the median score and IQR allowed for a more objective determination of question validity. The RAM may help select appropriate questions, contributing to the preparation of higher-quality tests.

The VR leadless pacemaker: Results of an expert panel using the RAND/UCLA method.

BACKGROUND: Leadless pacemakers were developed to reduce complications associated with transvenous pacemaker implantation and long-term follow-up. Existing international guidelines lack detailed instructions on patients suitable for leadless pacemaker implantation. Our aim was to develop a consensus document that provides medical guidance for all health professionals involved in the indication and implantation of Transcatheter Pacing System single-chamber device (VR leadless) pacemakers for patients with atrial fibrillation or in sinus rhythm. METHODS: A panel of experts, including interventional and non-interventional cardiologists, used the Research ANd Development/University of California at Los Angeles (RAND/UCLA) method to rate the appropriateness of leadless pacemaker implantation for 64 scenarios in patients with atrial fibrillation and 192 scenarios in sinus rhythm. The scenarios were rated individually and again during a moderated group session. Median ratings and level of agreement were calculated to classify each scenario as appropriate, inappropriate, or questionable. RESULTS: This consensus statement, based on available literature and the experts' opinions, summarizes recommendations for standardizing and optimizing leadless pacemaker implantation. The limitation for vascular access via the superior vena cava was the most influential variable when indicating leadless pacemaker implantation in both patients with atrial fibrillation and patients in sinus rhythm. CONCLUSIONS: Life expectancy, risk of infection, prosthetic valve, left ventricular ejection fraction (LVEF), limitation for vascular access via the superior vena cava, and mobility and exercise capacity determine who is advised to undergo VR leadless pacemaker implantation. More prospective studies are needed to optimize existing recommendations.

Developing quality indicators for cross-sectoral psycho-oncology in Germany: combining the RAND/UCLA appropriateness method with a Delphi technique.

BACKGROUND: Internationally, the need for appropriately structured, high-quality care in psycho-oncology is more and more recognized and quality-oriented care is to be established. Quality indicators are becoming increasingly important for a systematic development and improvement of the quality of care. The aim of this study was to develop a set of quality indicators for a new form of care, a cross-sectoral psycho-oncological care program in the German health care system. METHODS: The widely established RAND/UCLA Appropriateness Method was combined with a modified Delphi technique. A systematic literature review was conducted to identify existing indicators. All identified indicators were evaluated and rated in a two-round Delphi process. Expert panels embedded in the Delphi process assessed the indicators in terms of relevance, data availability and feasibility. An indicator was accepted by consensus if at least 75% of the ratings corresponded to category 4 or 5 on a five-point Likert scale. RESULTS: Of the 88 potential indicators derived from a systematic literature review and other sources, 29 were deemed relevant in the first Delphi round. After the first expert panel, 28 of the dissented indicators were re-rated and added. Of these 57 indicators, 45 were found to be feasible in terms of data availability by the second round of expert panel. In total, 22 indicators were transferred into a quality report, implemented and tested within the care networks for participatory quality improvement. In the second Delphi round, the embedded indicators were tested for their practicability. The final set includes 16 indicators that were operationalized in care practice and rated by the expert panel as relevant, comprehensible, and suitable for care practice. CONCLUSION: The developed set of quality indicators has proven in practical testing to be a valid quality assurance tool for internal and external quality management. The study findings could contribute to traceable high quality in cross-sectoral psycho-oncology by providing a valid and comprehensive set of quality indicators. TRIAL REGISTRATION: "Entwicklung eines Qualitätsmanagementsystems in der integrierten, sektorenübergreifenden Psychoonkologie-AP "Qualitätsmanagement und Versorgungsmanagement" zur Studie "integrierte, sektorenübergreifende Psychoonkologie (isPO)" a sub-project of the "integrierte, sektorenübergreifende Psychoonkologie (isPO)", was registered in the German Clinical Trials Register (DRKS) (DRKS-ID: DRKS00021515) on 3rd September 2020. The main project was registered on 30th October 2018 (DRKS-ID: DRKS00015326).

Arthroscopic repair for isolated subscapularis tear: successful functional outcomes and high tendon healing rate can be expected nine years after surgery.

BACKGROUND: Literature describing outcomes and integrity after isolated subscapularis (SSC) tendon repair is emerging but remains limited to a few small case series with short-term follow-up. The aim of this study was to evaluate the long-term clinical outcomes and repair integrity in patients who underwent arthroscopic repair of isolated SSC tears. METHODS: A retrospective study was conducted with the following inclusion criteria: (1) primary and elective shoulder arthroscopy for isolated SSC repair, (2) type III (a full-thickness tear in the upper two-thirds of the tendon) or IV (a complete tear without tendon retraction) SSC tear according to the Lafosse classification, and (3) a minimum 24-month follow-up. Preoperatively, the range of motion (ROM) and the Constant-Murley score (CMS) and at follow-up, the ROM, the University of California-Los Angeles (UCLA) Shoulder Rating Scale, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and the CMS were evaluated; an ultrasonographic assessment of tendon healing was performed according to the Sugaya classification. RESULTS: The final sample consisted of 45 patients with an average age of 55 ± 9 years. After a mean follow-up time of 107 ± 54 months, the mean UCLA and DASH scores were 8.7 ± 1.3 and 42.2 ± 6.4, respectively. ROM and CMS showed statistically significant improvements (all P < .001). Before surgery, the mean CMS was 49% that of sex- and age-matched healthy individuals, and all patients showed a CMS lower than the normative data. At the final follow-up visit, the mean CMS was 94.2% that of sex- and age-matched healthy individuals, and no patients showed CMS of 30 or less. The mean increase in the CMS was 41.4 ± 9.8 points (range, 23-60 points). The ultrasonographic assessment showed SSC tendon healing in 39 (86.7%) cases; tendon retear was recorded in 5 (13.3%) cases. All scores directly correlated with the healing of the tendon. A higher postoperative DASH score was associated with male sex (P = .039, ß = 5.538) and a longer follow-up period (P = .044, ß = 0.001). The postoperative CMS (P < .001) and UCLA scores (P = .001) were significantly higher in patients younger than 60 years of age at surgery than in older individuals. CONCLUSION: Arthroscopic repair of isolated SSC tears achieves excellent clinical and functional results at a mean of 9 years postoperatively, with a satisfactory healing rate. Better functional outcomes correlate with SSC tendon integrity and were observed in male patients and in those younger than 60 years at surgery.

Applicability and Validity of an e-Health Tool for the Appropriate Referral and Selection of Patients With Chronic Pain for Spinal Cord Stimulation: Results From a European Retrospective Study.

OBJECTIVES: To support rational decision-making on spinal cord stimulation (SCS), a European expert panel developed an educational e-health tool using the RAND/University of California at Los Angeles Appropriateness Method. This retrospective study aimed to determine the applicability and validity of the tool using data from patients for whom SCS had been considered. MATERIALS AND METHODS: A total of 12 European implant centers retrieved data from 25 to 50 consecutive patients for whom SCS was considered in 2018-2019. For each patient, data were captured on the clinical and psychosocial variables included in the e-health tool, center decisions on SCS, and patient outcomes. Patient outcomes included global perception of effect by the patient and observer, and pain reduction (numeric pain rating scale) at six-month follow-up. RESULTS: In total, 483 patients were included, of whom 133 received a direct implant, 258 received an implant after a positive trial, 32 had a negative trial, and 60 did not receive SCS for reasons other than a negative trial. The most frequent indication was persistent spinal pain syndrome type 1 and type 2 (74%), followed by neuropathic pain syndromes (13%), complex regional pain syndrome (12%), and ischemic pain syndromes (0.8%). Data on the clinical and psychosocial variables were complete for 95% and 93% of patients, respectively, and missing data did not have a significant impact on the study outcomes. In patients who had received SCS, panel recommendations were significantly associated with patient outcomes (p < 0.001 for all measures). Substantial improvement ranged from 25% if the e-health tool outcome was "not recommended" to 83% if SCS was "strongly recommended". In patients who underwent a trial (N = 290), there was 3% of trial failure when SCS was "strongly recommended" vs 46% when SCS was "not recommended". CONCLUSIONS: Retrospective application of the e-health tool on patient data showed a strong relationship between the panel recommendations and both SCS trial results and treatment outcomes.

[Loneliness in childhood and adolescence. On the prevalence of a mental health risk factor among 11- to 15-year-old German students]. / Einsamkeit im Kindes- und Jugendalter. Zur Verbreitung eines Risikofaktors für die psychische Gesundheit unter 11- bis 15-jährigen deutschen Schülerinnen und Schülern.

BACKGROUND: Loneliness is an increasingly present topic in both public and scientific discourse. There is increasing research on the prevalence of loneliness and health-related correlates in adults. However, there are only a few findings on loneliness in childhood and adolescence in Germany. Therefore, this study aims to present findings on the prevalence of loneliness among 11- to 15-year-old German students and examines associations with socio-demographic characteristics. METHODS: The Health Behaviour in School-aged Children (HBSC) study is a global research collaboration under the auspices of the World Health Organization (WHO). In the federal state of Brandenburg, Germany, the study collected data from 3819 children and adolescents in grades 5, 7, and 9 (Mage = 13.5, SD = 1.6) at schools for general education. Loneliness was assessed using the University of California, Los Angeles (UCLA) Loneliness Scale and a single item. RESULTS: Of the respondents, 13.2% reported feeling lonely most of the time and 3.6% always. Loneliness was more prevalent among girls and non-binary students, as well as among older students and children and adolescents of lower socioeconomic status. DISCUSSION: The findings indicate that loneliness is a widespread phenomenon among children and adolescents. The result that girls, older pupils and children, and adolescents with lower family wealth report feeling lonelier is consistent with findings from other countries and provides starting points for planning prevention measures. Further research is needed in Germany on possible health-related correlates of loneliness.

Evaluation of Behavior of Castable versus Machined Solid Abutments for Morse Tapper Implant Connection: A Clinical Retrospective Study.

Objective: The primary objective of the present retrospective clinical study was to evaluate and compare the clinical performance presented by castable abutments developed for the MT system versus intermediate machined abutments, specifically regarding prosthetic or implant fractures/loss; the secondary objective was to verify the looseness of the abutments and the behavior of the peri-implant soft tissues. Methods: This clinical retrospective study was conducted on patients rehabilitated between 2019 and 2020. Inclusion criteria were patients in good general health, with an implants-supporting single crown; with solid machined abutments (control group) or castable UCLA abutments; with a connection portion (base) machined in cobalt-chrome (test group) over Morse taper DuoCone implants in the posterior mandible area; and at least two years in function. Clinical assessment was carried out by the same professional, considering the following parameters: (A) prosthetic: (i) loosening of the fixation screw, (ii) fracture of the screw and (iii) the number of times the patient had some type of complication after the installation of the prostheses were evaluated; (B) biological: (i) without keratinized mucosa (KM), (ii) 1 mm or less, (iii) between 1 and 2 mm and (iv) greater than 2 mm of KM width; and the presence or absence of mucositis. Furthermore, radiographic evaluation was performed in order to assess the marginal bone loss. These evaluations permitted to compare the groups analyzed and patients enrolled. Data were statistically analyzed, with the level of significance set at α = 0.05. Results: 79 patients with 120 MT implants were evaluated (80 castable UCLA abutments and 40 machined solid abutments). The follow-up was from 2 to 4 years. There was a 100% implant survival rate. Therefore, the control group showed two fractured abutments (5%) and no abutment loosening (95% for prosthetic survival rate), whereas the test group showed no abutment fracture but nine loosening screws (11.3%) (100% for prosthetic survival rate). Keratinized mucosa was considered thin or absent in 19 implants in the control group (47.5%) and 42 in the test group (52.5%). Mucositis was found in 11 implants in the control group (27.5%) and 27 in the test group (33.8%). A positive correlation was observed between the width of keratinized mucosa and mucositis (r = 0.521, p = 0.002). The mean marginal bone loss was 2.3 mm, ranging from 1.1 to 5.8 mm. No correlation was observed when considering marginal bone loss versus the three parameters (implant diameter, implant length and time of the prosthesis in function). Conclusions: The results suggest that UCLA-type abutments are a viable option for rehabilitating implants with Morse taper connections, suggesting lower fracture risk. Further research is necessary to confirm these findings and thoroughly evaluate the clinical performance and long-term outcomes.

Frailty, psychological well-being, and social isolation in older adults with cognitive impairment during the SARS-CoV-2 pandemic: data from the GeroCovid initiative.

BACKGROUND: The containment measures linked to the COVID-19 pandemic negatively affected the phyco-physical well-being of the population, especially older adults with neurocognitive disorders (NCDs). This study aims to evaluate whether the frailty of NCD patients was associated with different changes in multiple health domains, in particular in relation to loneliness and social isolation, pre- and post-lockdown. MATERIALS AND METHODS: Patients were recruited from 10 Italian Centers for Cognitive Disorders and Dementia. Data were collected in the pre-pandemic period (T0), during the pandemic lockdown (T1), and 6-9 months post-lockdown (T2). The UCLA Loneliness Scale-3, Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini-Mental State Examination, and Neuropsychiatric Inventory (NPI) were administered. Caregivers' burden was also tested. Patients were categorized as non-frail, pre-frail, and frail according to the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale. RESULTS: The sample included 165 subjects (61.9% women, mean age 79.5 ± 4.9 years). In the whole sample, the ADL, IADL, and NPI scores significantly declined between T0 and T2. There were no significative variations in functional and cognitive domains between the frail groups. During lockdown we recorded higher Depression Anxiety Stress Scales and Perceived Stress Scale scores in frail people. In multivariable logistic regression, frailty was associated with an increase in social isolation, and a loss of IADL. CONCLUSIONS: We observed a global deterioration in functional and neuro-psychiatric domains irrespective of the degree of frailty. Frailty was associated with the worsening of social isolation during lockdown. Frail patients and their caregivers seemed to experience more anxiety and stress disorders during SARS-CoV-2 pandemic.

Appropriate use criteria for ancillary diagnostic testing in dermatopathology: New recommendations for 11 tests and 220 clinical scenarios from the American Society of Dermatopathology Appropriate Use Criteria Committee.

BACKGROUND: Appropriate use criteria (AUC) provide patient-centered physician guidance in test selection. An initial set of AUC was reported by the American Society of Dermatopathology (ASDP) in 2018. AUC reflect evidence collected at single timepoints and may be affected by evolving evidence and experience. The objective of this study was to update and expand AUC for selected tests. METHODS: RAND/UCLA (RAND Corporation [Santa Monica, CA]/University of California Los Angeles) methodology used includes the following: (a) literature review; (b) review of previously rated tests and previously employed clinical scenarios; (c) selection of previously rated tests for new ratings; (d) development of new clinical scenarios; (e) selection of additional tests; (f) three rating rounds with feedback and group discussion after rounds 1 and 2. RESULTS: For 220 clinical scenarios comprising lymphoproliferative (light chain clonality), melanocytic (comparative genomic hybridization, fluorescence in situ hybridization, reverse transcription polymerase chain reaction, telomerase reverse transcriptase promoter), vascular disorders (MYC), and inflammatory dermatoses (periodic acid-Schiff, Gömöri methenamine silver), consensus by panel raters was reached in 172 of 220 (78%) scenarios, with 103 of 148 (70%) rated "usually appropriate" or "rarely appropriate" and 45 of 148 (30%), "appropriateness uncertain." LIMITATIONS: The study design only measures appropriateness. Cost, availability, test comparison, and additional clinical considerations are not measured. The possibility that the findings of this study may be influenced by the inherent biases of the dermatopathologists involved in the study cannot be excluded. CONCLUSIONS: AUC are reported for selected diagnostic tests in clinical scenarios that occur in dermatopathology practice. Adhering to AUC may reduce inappropriate test utilization and improve healthcare delivery.

Attitudes of health professionals toward elderly patients during the COVID-19 pandemic.

The perceptions and attitudes of health professionals toward a certain group of society are among the factors affecting the quality of health service. This study aimed to investigate the attitudes of physicians and nurses about ageism in the COVID-19 pandemic. An easy face-to-face survey was used to collect the data. It involves the questions about demographic information and geriatric perspectives, and they were taken from the University of California at Los Angeles Geriatrics Attitudes Scale (UCLA-GAS). In the study, 58.1% of participants were over 35 years old, 76.6% were women, and 50% were physicians out of 308 in total. It was found that most of the participants have worked in inpatient services and intensive care units for the longest time, where the triage issue was the most discussed topic during the pandemic. An average of 75% of the participants stated that they did not witness any ageist attitude in health care provided. In the comparative analyses conducted with the UCLA-GAS sub-dimensions, statistically significant results, which were anti-ageist and prioritized human life, were obtained. In the extraordinary periods such as pandemic, especially physicians should be able to give the treatment without feeling any social or legal concerns during their medical applications with the light of guidelines accepted scientifically, legally, and morally. Thus, health professionals will not only be away from legal concerns such as malpractice but also will not be exhausted mentally and they can provide more sufficient health service by working under these conditions.

The University of California-Los Angeles (UCLA) shoulder scale: translation, reliability and validation of a Thai version of UCLA shoulder scale in rotator cuff tear patients.

BACKGROUND: UCLA Shoulder Scale is a useful evaluation tool to assess the functional outcome of shoulder after treatments. It has been translated into several languages. The objectives of this study were to translate UCLA Shoulder Scale into Thai language and validate the translated version in patients with rotator cuff tear. METHODS: This study consists of 2 phases: 1) Development of the Thai version of UCLA Shoulder Scale and 2) Validation of the translated version. The UCLA Shoulder Scale was translated into Thai according to the international guideline. Seventy-eight subjects with a mean age of 71 ± 11.5 took part in the study. All had shoulder pain and rotator cuff tear according to MRI from 2019 to 2020. Four patients were excluded due to incomplete questionnaires. The data from 21 patients whose symptoms in shoulder joint had not changed within 14 days were analyzed with the UCLA Shoulder Scale test-retest using intraclass correlation (ICC), Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC). The Thai version of UCLA Shoulder Scale was compared to the validated Thai versions of American Shoulder and Elbow Surgeons (ASES), Western Ontario Rotator Cuff (WORC) and Shortened version of The Disability of the Arm, Shoulder and Hand (QuickDASH) shoulder scores. RESULTS: Thai version of UCLA Shoulder Scale was developed following the guideline. Moderate to strong correlations were found using Spearman's correlation coefficient between pain, function and total score of Thai version of UCLA Shoulder Scale. The reliability of total UCLA Shoulder Scale was excellent (ICC = 0.99, 95% CI 0.97-1.00), whereas agreement assessed with SEM and MDC (0.18 and 0.50 respectively) demonstrated a positive rating. The validity analysis of total UCLA Shoulder Scale (Thai version) showed moderate to strong correlations with total ASES, total WORC and QuickDASH (Thai versions). The Thai version of UCLA Shoulder Scale showed no floor and ceiling effects from the results. CONCLUSION: The Thai version of UCLA Shoulder Scale is a reliable and valid tool for assessing the function and disability of the shoulder in Thai patients who have rotator cuff tear.

Planning and Reporting Effective Web-Based RAND/UCLA Appropriateness Method Panels: Literature Review and Preliminary Recommendations.

BACKGROUND: The RAND/UCLA Appropriateness Method (RAM), a variant of the Delphi Method, was developed to synthesize existing evidence and elicit the clinical judgement of medical experts on the appropriate treatment of specific clinical presentations. Technological advances now allow researchers to conduct expert panels on the internet, offering a cost-effective and convenient alternative to the traditional RAM. For example, the Department of Veterans Affairs recently used a web-based RAM to validate clinical recommendations for de-intensifying routine primary care services. A substantial literature describes and tests various aspects of the traditional RAM in health research; yet we know comparatively less about how researchers implement web-based expert panels. OBJECTIVE: The objectives of this study are twofold: (1) to understand how the web-based RAM process is currently used and reported in health research and (2) to provide preliminary reporting guidance for researchers to improve the transparency and reproducibility of reporting practices. METHODS: The PubMed database was searched to identify studies published between 2009 and 2019 that used a web-based RAM to measure the appropriateness of medical care. Methodological data from each article were abstracted. The following categories were assessed: composition and characteristics of the web-based expert panels, characteristics of panel procedures, results, and panel satisfaction and engagement. RESULTS: Of the 12 studies meeting the eligibility criteria and reviewed, only 42% (5/12) implemented the full RAM process with the remaining studies opting for a partial approach. Among those studies reporting, the median number of participants at first rating was 42. While 92% (11/12) of studies involved clinicians, 50% (6/12) involved multiple stakeholder types. Our review revealed that the studies failed to report on critical aspects of the RAM process. For example, no studies reported response rates with the denominator of previous rounds, 42% (5/12) did not provide panelists with feedback between rating periods, 50% (6/12) either did not have or did not report on the panel discussion period, and 25% (3/12) did not report on quality measures to assess aspects of the panel process (eg, satisfaction with the process). CONCLUSIONS: Conducting web-based RAM panels will continue to be an appealing option for researchers seeking a safe, efficient, and democratic process of expert agreement. Our literature review uncovered inconsistent reporting frameworks and insufficient detail to evaluate study outcomes. We provide preliminary recommendations for reporting that are both timely and important for producing replicable, high-quality findings. The need for reporting standards is especially critical given that more people may prefer to participate in web-based rather than in-person panels due to the ongoing COVID-19 pandemic.

A validated algorithm using current literature to judge the appropriateness of anatomic total shoulder arthroplasty utilizing the RAND/UCLA appropriateness method.

BACKGROUND: Currently, appropriateness criteria evaluating when to perform total shoulder arthroplasty (TSA) is lacking. In the absence of society guidelines and limited quality evidence, the RAND/University California in Los Angeles (UCLA) method provides a suitable alternative to evaluate appropriateness and assist in clinical decision making. Given the rise in utilization, appropriateness criteria for TSA have the potential to be an extremely powerful tool for improving quality of care and controlling costs. Thus, the goal of this study was to test explicit criteria to assess the appropriateness of TSA decision making using the RAND/UCLA appropriateness method. METHODS: A review of recent scientific literature to gather available evidence about the use, effectiveness, efficiency, and the risks involved in surgical intervention was performed by a shoulder/elbow fellowship trained physician. Based on pertinent variables including age, rotator cuff status, previous surgical management, mobility, symptomatology, and imaging classifications, 186 clinical scenarios were created. Appropriateness criteria for TSA were developed using a modified Delphi method with a panel consisting of American Shoulder and Elbow Surgeons (ASES) members. A second panel of ASES members rated the same scenarios, with reliability testing performed to compare groups. RESULTS: Panel members reached agreement in 40 (64%) indications. TSA was appropriate in 15 (24%) of indications. For patients with severe symptomatology, TSA was often appropriate for patients aged <75 years and inconclusive or inappropriate for patients aged >75 years. Among patients aged <65 years, TSA varied between appropriate and inconclusive, often dependent on Walch classification. For patients with moderate symptomatology, TSA was inappropriate or inconclusive for patients aged <65 or >75 years. When compared to the second panel's results, moderate agreement was obtained with a weighted kappa statistic of 0.56. CONCLUSIONS: Using the RAND/UCLA method, ASES members created an appropriateness decision tree for pertinent patient variables. This presents the data in a manner that streamlines the clinical decision-making process and allows for rapid and more reliable determination of appropriateness for practitioners. The decision tree is based on a combination of clinical experience from high-volume ASES-member surgeons and a comprehensive review of current evidence. This tool can be used as part of a broader set of factors, including individual patient characteristics, prior studies, and expert opinion, to inform clinical decision making, improve quality of care, and control costs.

Does Preoperative Activity Level Affect Postoperative Outcomes Following Total Hip Arthroplasty?

BACKGROUND: Many patients electing to undergo total hip arthroplasty (THA) value continuing active lifestyles when considering treatment options. Addressing these concerns requires evaluating the effect of preoperative activity level on patient-reported outcomes and improvement following THA. METHODS: Three hundred thirty-five patients (368 hips) who underwent THA with a minimum 6-month (mean 533 ± 271 days) follow-up completed preoperative and postoperative University of California, Los Angeles (UCLA) activity score along with various patient-reported measures of function, pain, and mental state. Preoperative UCLA score divided patients into inactive, mild, and active groups. Analysis of covariance controlling for age, sex, body mass index, surgical approach, implant, bilateral cases, conversions, and follow-up time evaluated differences among groups for postoperative outcomes with subsequent Tukey-Kramer pairwise comparisons. RESULTS: Mildly active patients (73:139 male:female) had better postoperative outcomes than inactive patients (40:70 male:female) for UCLA score, EuroQol Visual Analog Scale (EQVAS), Hip Outcome Score (HOS), 12-item Short-Form (SF-12) Physical, and Visual Analog Pain Scale (average/now/worst) (P values <0.001/<0.001/<0.001/<0.001/0.003/<0.001/<0.001). Active patients (32:14 male:female) had better postoperative outcomes than inactive patients for UCLA score, EQVAS, HOS, SF-12 Physical, and Visual Analog Pain Scale Worst (P values <0.001/0.024/0.001/0.001/0.017). No postoperative outcome differences existed between active and mild patients. Inactive patients displayed greater outcome improvements than mildly active patients for UCLA score, Harris Hip Score, and International Hip Outcome Tool (P values <0.001/<0.001/0.013) and active patients for UCLA score, EQVAS, HOS, International Hip Outcome Tool, and SF-12 Physical (P values <0.001/0.008/0.013/0.022/0.004). CONCLUSIONS: Inactive patients achieve greater measure improvements following THA. Active patients achieve better absolute outcomes than inactive patients; however, increasing activity levels do not incrementally improve patient-reported outcome measures. Patients similarly improve pain and mental health regardless of activity level.

The AAHKS Clinical Research Award: Are Minimum Two-Year Patient-Reported Outcome Measures Necessary for Accurate Assessment of Patient Outcomes After Primary Total Knee Arthroplasty?

BACKGROUND: The two-year minimum follow-up after total knee arthroplasty (TKA) required by most academic journals is based on implant survivorship studies rather than patient-reported outcome measures (PROMs). Additionally, the COVID-19 pandemic placed an unprecedented burden on patients and staff and halted asymptomatic surveillance clinic visits to minimize exposure. The purpose of this study was to determine if clinically meaningful differences were observed in PROMs beyond one year after TKA. METHODS: A retrospective review was performed on prospectively collected PROMs after 1093 primary TKAs at a suburban academic center. PROMs related to pain, function, activity level, and satisfaction were compared by subsequent follow-up intervals preoperatively, at 4 months, 1 year, and minimum 2 years using paired data analysis techniques. RESULTS: Pain with level walking and while climbing stairs improved from preoperative levels to 4-month, 1-year, and minimum 2-year follow-up. The University of California Los Angeles activity level and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement improved over the same intervals. Patient satisfaction improved over postoperative follow-up intervals (84.0%, 87.3%, and 90.9%). While PROMs improved with statistical and clinical significance preoperatively to 4-month to 1-year follow-up, improvements from 1-year to minimum 2-year follow-up were small and did not reach minimum clinically important differences for nearly all PROMs, demonstrating significant overlap of the 95% confidence intervals. CONCLUSION: While long-term follow-up after TKA remains important for implant survivorship, it appears that one-year PROMs are as clinically reliable and meaningful as two-year PROMs. Therefore, it is reasonable to question the currently accepted 2-year minimum follow-up requirement used in peer-reviewed research involving PROMs. LEVEL OF EVIDENCE: Level III.

A Machine-Learning-Based Analysis of the Relationships between Loneliness Metrics and Mobility Patterns for Elderly.

Loneliness and social isolation are subjective measures associated with the feeling of discomfort and distress. Various factors associated with the feeling of loneliness or social isolation are: the built environment, long-term illnesses, the presence of disabilities or health problems, etc. One of the most important aspect which could impact feelings of loneliness is mobility. In this paper, we present a machine-learning based approach to classify the user loneliness levels using their indoor and outdoor mobility patterns. User mobility data has been collected based on indoor and outdoor sensors carried on by volunteers frequenting an elderly nursing house in Tampere region, Finland. The data was collected using Pozyx sensor for indoor data and Pico minifinder sensor for outdoor data. Mobility patterns such as the distance traveled indoors and outdoors, indoor and outdoor estimated speed, and frequently visited clusters were the most relevant features for classifying the user's perceived loneliness levels.Three types of data used for classification task were indoor data, outdoor data and combined indoor-outdoor data. Indoor data consisted of indoor mobility data and statistical features from accelerometer data, outdoor data consisted of outdoor mobility data and other parameters such as speed recorded from sensors and course of a person whereas combined indoor-outdoor data had common mobility features from both indoor and outdoor data. We found that the machine-learning model based on XGBoost algorithm achieved the highest performance with accuracy between 90% and 98% for indoor, outdoor, and combined indoor-outdoor data. We also found that Lubben-scale based labelling of perceived loneliness works better for both indoor and outdoor data, whereas UCLA scale-based labelling works better with combined indoor-outdoor data.

The Paediatric AirWay Suction (PAWS) appropriateness guide for endotracheal suction interventions.

BACKGROUND/OBJECTIVE: Endotracheal suction is an invasive and potentially harmful technique used for airway clearance in mechanically ventilated children. Choice of suction intervention remains a complex and variable process. We sought to develop appropriate use criteria for endotracheal suction interventions used in paediatric populations. METHODS: The RAND Corporation and University of California, Los Angeles Appropriateness Method was used to develop the Paediatric AirWay Suction appropriateness guide. This included defining key terms, synthesising current evidence, engaging an expert multidisciplinary panel, case scenario development, and two rounds of appropriateness ratings (weighing harm with benefit). Indications (clinical scenarios) were developed from common applications or anticipated use, current practice guidelines, clinical trial results, and expert consultation. RESULTS: Overall, 148 (19%) scenarios were rated as appropriate (benefit outweighs harm), 542 (67%) as uncertain, and 94 (11%) as inappropriate (harm outweighs benefit). Disagreement occurred in 24 (3%) clinical scenarios, namely presuction and postsuction bagging across populations and age groups. In general, the use of closed suction was rated as appropriate, particularly in the subspecialty population 'patients with highly infectious respiratory disease'. Routine application of 0.9% saline for nonrespiratory indications was more likely to be inappropriate/uncertain than appropriate. Panellists preferred clinically indicated suction versus routine suction in most circumstances. CONCLUSION: Appropriate use criteria for endotracheal suction in the paediatric intensive care have the potential to impact clinical decision-making, reduce practice variability, and improve patient outcomes. Furthermore, recognition of uncertain clinical scenarios facilitates identification of areas that would benefit from future research.

Appropriateness of trifluridine/tipiracil in the clinical practice of third-line therapy in metastatic colorectal cancer.

Aim: To help to remove misperception of an appropriate position of trifluridine/tipiracil (FTD/TPI) in the treatment of metastatic colorectal cancer. Materials & methods: The RAND Corporation/UCLA Appropriateness Method was used by a panel of Italian experts to develop recommendations concerning daily practice with FTD/TPI. Forty-three clinical scenarios were discussed in two rounds and the resulting statements were rated as appropriate, uncertain or inappropriate, according to the median score. Results: Several topics were dealt with, covering the profile of eligible patients, therapeutic options beyond the second line, the practice of treatment with FTD/TPI, evaluation and efficacy and toxicity, as well as costs and compliance. Conclusion: FTD/TPI is an important therapeutic resource in refractory metastatic colorectal cancer that combines manageability and safety.

Lay abstract To remove misperception of trifluridine/tipiracil (FTD/TPI) in the treatment of metastatic colorectal cancer. An established Method for evaluating appropriateness of new drugs was used. Forty-three clinical scenarios were discussed in two rounds and the resulting statements were rated as appropriate, uncertain or inappropriate, according to the median score. Several topics were dealt with, covering the profile of eligible patients, therapeutic options beyond the second line, efficacy and toxicity, as well as compliance. FTD/TPI is an important therapeutic resource in refractory metastatic colorectal cancer that combines manageability and safety.

Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.

BACKGROUND: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders. METHODS: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting. RESULTS: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged "appropriate"; 19 were judged "uncertain"; and none was judged "inappropriate". After the second round, 9 "uncertains" changed to "appropriate". All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = "extremely inappropriate", 5 = "uncertain", 9 = "extremely appropriate"). The sections "General recommendations" and "Gender perspective during the consent process for clinical studies" showed the highest "uncertainty" rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators' communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant's possible lack of health literacy and a glossary of terms. CONCLUSIONS: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged "appropriate" by all stakeholders involved in the informed consent process.