Patient-related Outcome Measures Research Articles

CTCA Prior to Invasive Coronary Angiography in Patients With Previous Bypass Surgery: Patient-Related Outcomes, Imaging Resource Utilization, and Cardiac Events at 3 Years From the BYPASS-CTCA Trial.

In patients with previous coronary artery bypass grafting, computed tomography cardiac angiography (CTCA) before invasive coronary angiography (ICA) was demonstrated in the BYPASS-CTCA trial (Randomized Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients) to reduce procedure time and incidence of contrast-associated acute kidney injury, with greater levels of patient satisfaction. Patient-related outcomes, utilization of further diagnostic imaging resources, and longer-term incidence of major adverse cardiac events were key secondary end points not yet reported. Patients with prior coronary artery bypass grafting referred for ICA were randomized 1:1 to undergo CTCA before ICA or ICA alone and followed up for a median of 3 (2.2-3.4) years. Angina status was assessed using the Seattle Angina Questionnaire and overall quality of life using the EQ-5D-5L. The incidence of noninvasive imaging use and major adverse cardiac events were compared between the 2 groups. In all, 688 patients were randomized, 344 to CTCA+ICA and 344 to ICA only. The mean age of participants was 69.8 years, with 45% undergoing ICA for acute coronary syndromes and the remainder stable angina. At 3 months follow-up, patients in the CTCA+ICA group were more likely to be angina-free (51.7% versus 43.2%; P=0.03) with greater quality of life (EQ-5D-5L index, 81.6 versus 74.4; P=0.001), although these improvements did not persist. At 3 years follow-up, imaging resource use (35.8% versus 45.1%; odds ratio, 0.68 [95% CI, 0.50-0.92]; P=0.013) and incidence of major adverse cardiac events were lower in the CTCA+ICA group (35.8% versus 43.5%; hazard ratio, 0.73 [95% CI, 0.58-0.93]; P=0.010). In patients with prior coronary artery bypass grafting undergoing ICA, CTCA before ICA leads to reductions in the use of imaging resources and the rate of major cardiac events out to 3 years, but with similar patient-related outcome measures. Together with the initial findings of BYPASS-CTCA, these data are supportive of routinely undertaking a CTCA before ICA in patients with prior coronary artery bypass grafting. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03736018.

Metal-Free Custom-Made Zirconia Implants-A Prospective 5-Year Follow-Up Single-Arm Clinical Trial.

Dental implants made of zirconia (ZrO2) are a potential alternative for titanium implants in dentistry because of their good biocompatibility, mechanical properties and excellent aesthetic results. However, solid long-term scientific data to prove clinical success of ZrO2 implants are scarce. The aim of this study was to describe and to examine the clinical performance of custom-made two-piece ZrO2 implants, to identify possible influencing factors: a) manipulation of the implant after placement and b) the occlusal scheme on the survival rate, and to evaluate the performance of the implant-supported crown. This follow-up study collected and examined the 5-year data to answer the main question: What are the survival and the success rates of custom-made ZrO2 implants in the maxillary premolar region after 5 years? Of the 31 included patients in this prospective 5-year follow-up single-arm clinical trial, 30 received a custom-made ZrO2 implant to replace a missing single maxillary premolar, which was subsequently restored with a lithium disilicate crown. Parameters regarding clinical performance, marginal bone-level (MBL) changes, and patient-related outcome measures (PROMs) were assessed preoperatively, at the baseline, as well as 1 and 5 years after crown placement. Chances of survival and success of the implant were calculated and displayed using Kaplan-Meier statistics. Kaplan-Meier survival analysis was also performed with stratification based on the variables "manipulation of the implant prior to impression taking" and "occlusal scheme" and compared using log-rank tests. Bone-level moderation in time was compared using a paired samples t-test. Patient's expectations and satisfaction after 5 years were compared as a measure of fulfilled expectations, using a Wilcoxon signed-rank test. Performance of the implant-supported crowns was evaluated using validated criteria. Survival and success probabilities after 5 years were, respectively, 75.8% (95% CI [60.0%; 91.0%]) and 71.0% (95% CI [54.0%; 88.0%]) for the custom-made ZV3 implants. No significant differences in survival rate were found after stratification on "manipulation of the implant" and on "occlusal scheme." Mean bone-level alteration between baseline and the first follow-up was +0.06 mm (95% CI [-0.23 mm; 0.12 mm]; SD = 0.42 mm) and between baseline and the second follow-up was +0.04 mm (95% CI [-0.35 mm; 0.26 mm]; SD = 0.54 mm). Patients' satisfaction for patients with implants still in function after 5 years was 91.7% (IQR = [90.5%-97.3%]), indicating satisfaction with the treatment. Pooled satisfaction in patients with successful implants after 5 years was significantly higher than patients' expressed expectations before treatment. None of the crowns failed, and no interventions were required. Survival rate of these particular ZV3 implants in our study was lower than expected and clinically not acceptable. Hence, ZV3 implant placement as applied in this study cannot be recommended for clinical practice. Further research on the different appearances of mechanical failure in ZrO2 implants would be highly recommended before a larger prospective randomized clinical trial is conducted to evaluate treatment with custom-made ZrO2 dental implants.

Non-invasive respiratory support in children and young adults with complex medical conditions in pediatric palliative care

ObjectiveDyspnoea and sleep-disordered breathing (SDB) are common in children with life-limiting conditions but studies on treatment with non-invasive ventilation (NIV) or continuous positive airway pressure (CPAP) are scarce. The aim...

7816 Implementation And Evaluation Of Clinical Care Structures For People With Differences Of Sex Development (DSD) In Germany

Abstract Disclosure: S.O. Hiort: None. M. Schnoor: None. U. Doehnert: None. M. Juergensen: None. J. Scherf: None. A. Heidenreich: None. M. Rapp: None. A. Katalinic: None. People with Differences of Sex Development (DSD) pose a challenge for healthcare. Lifelong holistic care requires a broad range of diagnostic approaches, qualified psychosocial, peer, fertility and sexual counselling, and structured therapeutic strategies including gonadal monitoring, hormone or surgical therapy. A quest has been taken to define centers of expertise for DSD and to substantiate and evaluate quality of care. Based on the criteria defined by the European Reference Network (ERN) for Rare Endocrine Conditions, 10 health care providers in Germany qualify for specialized DSD care. Quality indicators (QI) were developed through a Donabedian model to define structure, process and outcome quality mainly based on the German national guideline ”Differences of Sex Development”. Additionally, a consensus was reached though a structured process involving participating centers as well as patient organizations. Structural QIs are collected by an annual survey from the participating centers. Patient-related process and outcome data are recorded in a central registry. Patients and legal guardians receive questionnaires to collect patient-related outcome and experience measures after visits. These are measured by CHC-SUN/ YHC-SUN for treatment satisfaction and KIDDY KINDL, KIDSSCREEN 52, or WHOQOL-BREF for quality of life. An annual evaluation of all data results in a benchmarking of the participating centers. 24 indicators for structural quality were consented, 7 for process and 8 for outcome quality. Indicators of process quality comprise e.g. diagnostic procedures, case conferences, peer counseling or patient education. For structural quality there was an increase of centers fulfilling the QIs in 14 items including e.g. team composition and qualification during the study period from 2020 until 2022. Still very few centers had fixed standard operating procedures e.g. for gonadal monitoring or long-term follow up after surgery. 601 people with DSD were included into the registry from May 2021 until June 2023. In process quality there were considerable differences between centers both in QI compliance and data quality. The proportion of individuals with a genetic diagnosis varied by center from 44% to 96%. Information from questionnaires was available from 445 participants. Satisfaction with care was high. Parents reported in 86% to be very or highly satisfied with the visit, children and adolescents in 76%, and adults in 77%. Our approach allows for detailed evaluation of structural, process, and outcome quality. Health care insurers have secured appropriate funding for continuous evaluation of DSD care and the maintenance of the registry. This will allow for sustainability of the benchmarking and improvement of health care provision for people with DSD. Presentation: 6/1/2024

The use of amniotic membrane injection as an adjunct in endoscopic urethral stricture management.

Endoscopic urethral stricture treatment has high recurrence rates. Due to research supporting amniotic membrane's (AMs) anti-inflammatory and anti-fibrotic properties reducing scar tissue formation, AM has generated interest in reconstructive urethral surgery. To the best of our knowledge, we performed the first investigation of the success rate of urethral dilation when combined with micronized AM injection for the treatment of urethral stricture. Eligible patients were adult males with anterior strictures meeting strict criteria for diameter, length, International Prostate Symptom Score (IPSS), and flow rate. Micronized AM was injected in the stricture region during urethral dilation. The primary study endpoint was an anatomical success (≥14Fr) at 6 months. Secondary endpoints were evaluated with the IPSS, urethral stricture surgery - patient-related outcome measure, International Index of Erectile Function, flow rate, and postvoid residual. Outcomes were assessed at baseline and multiple points postinjection. Injection safety was analyzed. Ten men with a mean age of 52 years were included in the study. At 6 months, 7 of 10 patients demonstrated recurrence of the urethral stricture on cystoscopy. Improvements in secondary endpoints were noted in 10 of 10 patients at 3 months and 3 of 10 patients at 6 months. No adverse events were observed. To the best of our knowledge, this is the first study evaluating micronized AM injection as an adjunct treatment at the time of urethral dilation. The urethral stricture recurrence rate did not improve with the injection of AM despite the hypothesized benefits of anti-fibrotic and anti-inflammatory properties.

Biological Patch in the Repair of Rotator Cuff Tears: Functional and Clinical Evaluation of Twenty-Three Cases with a Mean Follow-Up of Six Years.

Background: Rotator cuff (RC) repair leads to less than optimal results when dealing with massive lesions, so the use of scaffolds as biological support has been proposed to improve RC repair site biology. The present study aims to evaluate the clinical and radiographical outcomes of a series of patients suffering from massive or irreparable RC tears treated with patch (porcine or human scaffolds) repair (augmentation or bridging). Methods: Twenty-three patients with a minimum follow-up of 24 months were subjectively, clinically, and radiographically assessed before and after surgery. Three different patient-related outcome measurements (PROMs) (American Shoulder and Elbow Surgeons score, Constant score, visual analog scale) were used for the subjective and clinical evaluation, while plain radiographs and magnetic resonance imaging where employed for radiographical follow-up. Results: Regardless of the technique (augmentation or bridging) or type of scaffold (porcine or human) employed, at follow-up, all patients experienced a statistically significant improvement in all PROMs and clinically. Conclusions: Patch repair represents a valid salvage procedure in massive or irreparable RC tears, improving the quality of life and eventually delaying the need for prosthetic replacement.

Patient-related outcome measures (PROM) in adult cochlear implant patients

Cochlear implants (CI) provide individuals with severe sensorineural hearing loss the opportunity for artificial auditory perception. The standardized documentation of speech intelligibility tests is widespread, while the systematic capture of patient-related outcome measures (PROMs) remains inconsistent. Relevant PROM instruments were evaluated and selected based on the criteria of dissemination, clarity, and relevance, integrated into routine clinical practice, and tested at longitudinal time points. A total of three PROM instruments were selected and successfully integrated into the clinical routine. The comparison of 2measurement points from 25individuals showed improvements in subjective speech comprehension and tinnitus perception. This study demonstrates the clinical implementation and integration of PROMs in adult CI candidates and patients. The PROMs are apromising tool to support various phases of treatment, both as adecision aid for potential CI candidates and for monitoring after implantation.

Randomised Placebo-Controlled Pilot Trial Evaluating the Anti-Anginal Efficacy of Ticagrelor in Patients with Angina with Nonobstructive Coronary Arteries and Coronary Slow Flow Phenomenon.

Background: The coronary slow flow phenomenon (CSFP) is an angiographic finding characterised by the delayed passage of contrast through the coronary arteries, despite the absence of obstructive coronary artery disease (defined as less than 50% narrowing of the vessel lumen). Patients with the CSFP experience recurrent angina, for which there are limited evidence-based therapies. Ticagrelor may serve as an effective anti-anginal therapy for these patients by increasing adenosine levels, which could alleviate coronary microvascular dysfunction and its associated angina due to its vasodilatory properties. This study aimed to determine the anti-anginal efficacy of ticagrelor 90 mg taken twice daily on spontaneous angina episodes in patients with refractory angina (i.e., episodes ≥3/week despite two anti-anginals) and documented CSFP. Methods: In a randomised, double-blind, placebo-controlled, cross-over trial, the anti-anginal efficacy of a 4-week ticagrelor therapy regimen was evaluated in 20 patients with refractory angina (mean age 61.5 ± 10.5 years; 40% women) who had documented slow coronary flow. The primary endpoint was the frequency of angina episodes, recorded using an angina diary. Secondary endpoints included the duration and severity of angina episodes, consumption of short-acting nitrates, and health status evaluations using the Seattle Angina Questionnaire (SAQ) and the Short Form-36 (SF-36) indices. Results: During the four weeks of therapy, ticagrelor did not significantly improve angina symptoms compared to the placebo (placebo 25.7 (16.7)) vs. ticagrelor 19.8 (18.1), p > 0.05). Furthermore, it did not impact other patient-related outcome measures, including angina severity, duration, frequency of prolonged angina episodes, nitrate consumption, or the SAQ/SF-36 health outcome indices. No serious adverse events related to the study drug were observed. Conclusions: In patients with documented CSFP who were unresponsive to standard anti-anginal therapy, ticagrelor did not reduce the frequency of spontaneous angina episodes or the consumption of nitrates. Further confirmation of the potential benefits of this therapy may be obtained through a larger clinical trial.

In the medium term, more than half of males report kinesiophobia after anterior cruciate ligament reconstruction

ObjectivesAnterior cruciate ligament rupture is a serious trauma with long-term consequences for the patient. Psychological and physiological factors may negatively affect patient recovery after anterior cruciate ligament reconstruction (ACLR), and development of kinesiophobia is possible. The aim of this study was to examine the presence of kinesiophobia and lower-leg muscle strength recovery in both sexes after ACLR. Methods140 ACLR patients agreed to participate in the study. Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK). The Knee injury and Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS) and Tegner Activity Scale (TAS) were used for patient-related outcome measurements. In both legs quadriceps and hamstring muscle strength at 60°/s and 180°/s were measured with an isokinetic dynamometer. For dynamic balance and leg function, the Y-balance test and single-leg hop test were used. Results100 (71%) males and 40 (29%) females—mean age 32.5 (±8.3)—were examined 5.5 (±1.25) years after ACLR. 68/140 patients (48.6%) reported a TSK kinesiophobia score equal to or higher than 37 points: 54/100 (54%) males and 14/40 (35%) females (p ​= ​0.04). Patients with kinesiophobia had significantly lower KOOS values (p ​< ​0.001). In terms of the TAS no significant differences were found between those with or without kinesiophobia. Knee strength deficiency at 180°/sec and 60°/sec was significantly higher in the kinesiophobia group in knee extension in males (p ​= ​0.009) and knee flexion in females (p ​= ​0.001). Normalized body weight isokinetic average peak torque strength tests were significantly better in males compared to females in both groups (p ​< ​0.001). ConclusionBoth sexes reported high rates of kinesiophobia, but males are at higher risk of developing kinesiophobia than females in the medium term after ACLR. Furthermore, patients with kinesiophobia have significantly lower total KOOS scores, and females were significantly weaker than males in knee flexion and extension according to normalized body weight muscle strength tests. Also, a longer time from injury to surgery increases the risk of kinesiophobia in females. Level of evidenceLevel IV. Type of studyRetrospective case series study. Clinical trial registrationTrial registration in ClinicalTrials.gov. Identifier: NCT05762809.

Outcomes of press-fit radial head arthroplasty in unconstructable radial head fractures with associated elbow injuries: An average 5-year follow up.

Unstable and nonreconstructable radial head fractures require radial head arthroplasty (RHA) to restore stability. Multiple implant designs are available with varying survival rates (76 to 97%). There is concern that loosening of the press-fit stems leads to implant failure. We review our outcomes using the Acumed press-fit prosthesis for trauma. Between February 2008 and November 2020, all primary RHA for trauma from a single-centre were reviewed. Primary outcome was implant survivorship. Secondary outcome were clinical, radiographic and patient related outcome measures. In total, 96 cases were included. Seven revisions were recorded, all within 24-months of implantation. Kaplan-Meier estimated 10-year survival was 92.1% (95% confidence interval (CI) 84.0-96.1%). Median follow-up time was 5.7 years (Interquartile range (IQR) 3.2-8.5 years). Median Oxford Elbow Score was 43 (IQR 29-46) for and median Mayo Elbow Performance Score was 90 (IQR 72-100). 72% were able to fully-return to pre-injury activities. Radiographic analysis identified osteolysis around radial neck (48%), loosening (32%), valgus stem position (20%), heterotopic ossification (16%) and capitellar erosion (15%). No radiological findings were associated with long-term poor clinical outcomes. Our study demonstrates an excellent survival of press-fit RHA of 92.1% at 10-years. No radiographic features on follow-up were associated with poorer patient recorded outcome measures.

Favourable mid-term isokinetic strength after primary THA combined with a modified enhanced recovery after surgery concept (ERAS) in a single blinded randomized controlled trial

PurposeMuscular deficits as part of severe osteoarthritis of the hip may persist for up to two years following total hip arthroplasty (THA). No study has evaluated the mid-term benefit of a modified enhanced-recovery-after-surgery (ERAS) concept on muscular strength of the hip in detail thus far. We (1) investigated if a modified ERAS-concept for primary THA improves the mid-term rehabilitation of muscular strength and (2) compared the clinical outcome using validated clinical scores.MethodsIn a prospective, single-blinded, randomized controlled trial we compared patients receiving primary THA with a modified ERAS concept (n = 12, ERAS-group) and such receiving conventional THA (n = 12, non-ERAS) at three months and one year postoperatively. For assessment of isokinetic muscular strength, a Biodex-Dynamometer was used (peak-torque, total-work, power). The clinical outcome was evaluated by using clinical scores (Patient-Related-Outcome-Measures (PROMs), WOMAC-index (Western-Ontario-and-McMaster-Universities-Osteoarthritis-Index), HHS (Harris-Hip-Score) and EQ-5D-3L-score.ResultsThree-months postoperatively, isokinetic strength (peak-torque, total-work, power) and active range of motion was significantly better in the modified ERAS group. One year postoperatively, the total work for flexion was significantly higher than in the Non-ERAS group, whilst peak-torque and power did not show significant differences. Evaluation of clinical scores revealed excellent results at both time points in both groups. However, we could not detect any significant differences between both groups in respect of the clinical outcome.ConclusionWith regard to muscular strength, this study supports the implementation of an ERAS concept for primary THA. The combination with a modified ERAS concept lead to faster rehabilitation for up to one-year postoperatively, reflected by significant higher muscular strength (peak-torque, total-work, power). Possibly, because common scores are not sensitive enough, the results are not reflected in the clinical outcome. Further larger randomized controlled trials are necessary for long-term evaluation.

Beyond frequency: Evaluating the validity of assessing the context, duration, ability, and botherment of depression and anxiety symptoms in South Brazil.

Assessment tools for depression and anxiety usually inquire about the frequency of symptoms. However, evidence suggests that different question framings might trigger different responses. Our aim is to test if asking about symptom's context, ability, duration, and botherment adds validity to Patient Health Questionnaire-9, General Anxiety Disorder-7, and Patient-Related Outcome Measurement Information Systems depression and anxiety. Participants came from two cross-sectional convenience-sampled surveys (N = 1,871) of adults (66% females, aged 33.4 ± 13.2), weighted to approximate with the state-level population. We examined measurement invariance across the different question frames, estimated whether framing affected mean scores, and tested their independent validity using covariate-adjusted and sample-weighted structural equation models. Validity was tested using tools assessing general disability, alcohol use, loneliness, well-being, grit, and frequency-based questions from depression and anxiety questionnaires. A bifactor model was applied to test the internal consistency of the question frames under the presence of a general factor (i.e., depression or anxiety). Measurement invariance was supported across the different frames. Framing questions as ability (i.e., "How easily …") produced a higher score, compared with framing by context (i.e., "In which daily situations …"). Construct and criterion validity analysis demonstrate that variance explained using multiple question frames was similar to using only one. We detected a strong overarching factor for each instrument, with little variances left to be explained by the question frame. Therefore, it is unlikely that using different adverbial phrasings can help clinicians and researchers to improve their ability to detect depression or anxiety. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Dental Autotransplantation or Immediate Single Implant for the Replacement of a Hopeless Molar: A Comparative Case Series Study.

Dental autotransplantation (ATT) of mature teeth in adult patients has recently been supported by a growing body of evidence. Thus, ATT can be considered as an alternative to single implants for the replacement of a compromised tooth. This case series study aims to provide an initial comparison between ATT (test group) and immediate implant treatment (IIT standard group), in terms of volumetric changes and patient-related outcome measures (PROMs). Thirty-one interventions (29 patients) were grouped into two similar cohorts. Measurements were made on the superimposed STL files before and at least six months after treatment, and PROMs were obtained from a questionnaire in two follow-up checks. Data were analyzed using descriptive and inferential statistics. Adverse events and complications were also recorded. Volume reduction was 3 to 4 times less in the ATT group than in the ITT group (p<0.05). Patients in the ATT group reported higher levels of perceived inflammation than the IIT group (p&#61;0.015), although patients rated satisfaction similarly between the two treatments, above 9 on a scale of 1-10. Although this research should be considered an initial step requiring larger samples and follow-up, it supports the trend of including ATT as an alternative option to IIT in molar replacement.

Factors in the Effective Use of Hearing Aids among Subjects with Age-Related Hearing Loss: A Systematic Review.

Objectives: Investigate factors contributing to the effective management of age-related hearing loss (ARHL) rehabilitation. Methods: A systematic review was conducted following PRISMA guidelines. The protocol was registered in PROSPERO (CRD42022374811). Articles were identified through systematic searches in the Scopus, PubMed, Web of Science, and Cochrane databases in May 2024. Only articles published between January 2005 and May 2024 were included. Studies were assessed for eligibility by two independent researchers and evaluated using the Crowe Critical Appraisal Tool v1.4 (CCAT). Results: Of the 278 articles identified, 54 were included. Three factors explain effective HA use. First, hearing aid signal processing, with directional microphones and noise reduction, improves user comfort and understanding regarding noise. Second, there is hearing aid fitting, with the NAL prescription rules as the gold standard, and bilateral, high-level HA performance for spatial localization and noise comprehension. Third, there is a patient-centered approach, using patient-related outcome measures (PROMs), questionnaires, counseling, and regular follow-up to involve patients in their therapeutic rehabilitation. Conclusions: Reaching a consensus on acoustic parameters is challenging due to variability in audiological results. Involving patients in their rehabilitation, addressing their needs and expectations, and offering individualized care are crucial.

Temporal changes in tibiofemoral relationship following anterior cruciate ligament injury: Implications for rotational dynamics and clinical outcomes.

This study aims to elucidate changes in the tibiofemoral relationship over time following anterior cruciate ligament (ACL) injury, and investigate the correlation between the tibiofemoral relationship and patient-related outcome measures (PROMs). Overall, 203 primary ACL reconstructions were performed using autologous hamstring grafts. Medial and lateral anterior tibial translation (ATT) in the sagittal plane and tibial tubercle-trochlear groove (TT-TG) distance in the axial plane were measured using pre-operative magnetic resonance imaging and post-operative computed tomography. The difference between pre-operative and post-operative values for each parameter was calculated: ΔMesdial ATT, ΔLateral ATT and ΔTT-TG distance. The correlation between each calculated value and the time elapsed since ACL injury, and the correlation between each calculated value and PROMs-evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS)-were assessed. Sixty-four patients were enroled. Medial ATT, lateral ATT and TT-TG distance were significantly different pre-operatively compared to post-operative values, with the tibia translating anteriorly and rotating internally relative to the femur. ΔMedial ATT, ΔLateral ATT and ΔTT-TG distance were 1.6, 8.8 and -4.8 mm, respectively. A negative correlation was observed between the ΔTT-TG distance and the time elapsed since the injury (r = -0.44, p < 0.01). No correlation was found between ΔMedial ATT and the time elapsed since the injury, nor between ΔLateral ATT and the time elapsed since the injury. Neither the ΔMedial ATT, ΔLateral ATT, nor ΔTT-TG distance correlated with the pre-operative or post-operative KOOS subscale scores. The tibia underwent internal rotation relative to the femur over time following ACL injury, highlighting the importance of assessing rotational changes in ACL-injured knees. Level Ⅲ.

Silicone Arthroplasty as an Alternative to Arthrodesis in the Metatarsophalangeal Degenerative Disease of Hallux Valgus-A 5-Year Observational Study.

Background: Arthroplasty is gaining more and more popularity in the treatment of osteoarthritis (OA) of the metatarsophalangeal I joint (MTP1). The aim of our study was to evaluate the early and long-term objective clinical and radiographic results, as well as the subjective results, of MTP1 arthroplasty in comparison to MTP1 arthrodesis among patients with OA and a valgus deformity of their MTP 1 joint. Methods: Patients with OA MTP1 were examined before surgery and in the 5-year period after surgery. The inclusion criteria for the study were OA of the MTP1 joint and a non-axial position of the toe in valgus between 20 and 40 degrees. Prostheses were created for the patients with higher demands for mobility of their MTP 1 joint and arthrodesis was carried out for those with lower expectations. The treatment outcomes were assessed by clinical examination, radiography, the AOFAS scale, the SEFAS scale, and using patient-related outcome measures (PROM). Results: A total of 39 people, 37 women and 2 men, aged 55 to 67 years old (average, 61 years old) participated in the study. During the follow-up period, there were no complications in the form of infection or a loosening of the implant after both arthroplasty and arthrodesis. The follow-up examination 60 months after the surgery showed an improvement in scores (>20 points) on both the AOFAS and SEFAS scales. All patients, after surgery, reported reduced pain. Conclusions: The use of a silicone prosthesis in the surgical treatment of degenerative changes in the MTPI joint, with appropriate indications and excluding cases with large hallux valgus, gives better results than arthrodesis.

European Board and College of Obstetrics and Gynaecology (EBCOG) position statement on the use of laser vaginal devices for treatment of genitourinary syndrome of menopause, vaginal laxity, pelvic organ prolapse and stress urinary incontinence

One in three women will experience pelvic floor disorders in her lifetime and nearly 60 percent of postmenopausal women are affected by vaginal dryness. Conservative management is recommended as first line treatment for pelvic organ prolapse and stress urinary incontinence. Also, vaginal estrogens are often prescribed for symptomatic vaginal atrophy. Lasers have been used in cosmetic industry for connective tissue remodeling and repair of skin. Their use in the last decade for treating genitourinary symptoms of menopause, pelvic organ prolapse and stress urinary incontinence has gained popularity but there is lack of robust evidence to support its use in routine practice. The European Board and College of Obstetrics and Gynaecology calls for high quality evidence with patient related outcome measures before adopting to routine clinical practice.

Health-related quality of life by type of breast surgery in women with primary breast cancer: prospective longitudinal cohort study.

Health-related quality of life and patient-related outcome measures for patients with cancer have gained increased interest over the last decade. However, few prospective studies with longitudinal data evaluated health-related quality of life in patients with breast cancer. This study aimed to investigate how health-related quality of life changed from the time of diagnosis to 1 year after breast cancer surgery for the main surgical techniques. This prospective longitudinal single-centre study included patients with primary breast cancer diagnosed in 2019-2020 who underwent surgery. Patients completed a health-related quality of life questionnaire (Breast-Q) at baseline. One year after surgery, they completed the Breast-Q a second time, the EORTC (European Organization for Research and Treatment of Cancer) quality of life questionnaire-C30 and the quality of life questionnaire-BR23. Analysis of variance and Kruskal-Wallis tests were used to evaluate the differences in health-related quality of life between surgical groups. Analysis of covariance with robust standard errors was used to adjust for confounders. In total, 340 patients were included in the study; 160 patients received oncoplastic partial mastectomy, 112 received partial mastectomy, 42 received mastectomy and 26 had mastectomy with immediate reconstruction. Patients that had partial mastectomy or oncoplastic partial mastectomy were more satisfied with their breasts (P < 0.001), had a better body image (P = 0.006) and higher sexual functioning scores (P = 0.027) than patients who had a mastectomy with/without reconstruction. The oncoplastic and mastectomy with reconstruction groups had more breast symptoms than other groups (P < 0.001), and the mastectomy group had the least symptoms from the chest area. Partial mastectomy and oncoplastic partial mastectomy have the best outcomes in terms of breast satisfaction, body image and sexual functioning. This highlights the importance of preserving the breast when feasible and underscores that breast reconstruction is not equal to breast conservation. Registration number: NCT04227613 (http://www.clinicaltrials.gov).

Comparison of Dorsal Preservation Rhinoplasty Techniques: Functional and Aesthetic Review of Subdorsal Septal Strip Methods.

Objective: To compare subdorsal strip excisions in patients undergoing dorsal preservation (DP) rhinoplasty using patient-related outcome measures (PROMS). Methods: Patients were treated from 2020 to 2022 using the modified subdorsal strip method (MSSM) or Z flap approach. A two-sample t-test determined whether there was a difference in functional and aesthetic scores using the NOSE, Sinonasal Outcome Test (SNOT-22), SCHNOS, and ESS scales. Results: Seventy-one primary rhinoplasty patients met inclusion criteria at 12 months with an average age of 23 years (62 female, 9 male), with 35 (49%) undergoing the MSSM technique, while 36 (51%) receiving the Z flap. PROMS at 1, 3, 6, and 12 months postoperatively were compared. The average preoperative and postoperative NOSE score was 9.36 and -4.4 (standard deviation [SD] 3.1, p < 0.001). The average preoperative SNOT-22 score was 23.9 and -16.4 (SD 10.2, p < 0.001). ESS scores was average was 6.2 and -1.6 (SD 3.2, p = 0.01). The average SCHNOS total, functional, and cosmetic scores were 27.6 (6-47), 8.2 (0-20) and 18.7 (0-37), respectively, and -5.7 (SD 8.2, p < 0.001), -5.73 (SD 6.24, p < 0.001), -18.1 (SD 9.7, p < 0.001). No significant complications were found and no difference in PROMs among groups. Conclusion: There was no difference in septal strip techniques as evaluated by PROMS.

Clinical outcomes after hip arthroscopy in acetabular dysplastic patients, previously treated with periacetabular osteotomy: a minimum of two-year follow-up data from the Danish Hip Arthroscopy Registry

ABSTRACT Periacetabular osteotomy (PAO) is the treatment of choice in dysplastic acetabulum. Due to continued symptoms, 2–11% of these patients require an additional hip arthroscopy. The purpose of this study was to report clinical outcome after a minimum of 2-year follow-up of additional hip arthroscopy after PAO with data from Danish Hip Arthroscopy Registry. Inclusion criteria in the study cohort were PAO surgery resulting in an additional hip arthroscopy procedure. The cohort was evaluated according to the surgical findings and patient-related outcome measures (PROMs) pre-operatively and at 2-year follow-up. A total of 287 patients were included in the study cohort. PROMs improved significantly in all subscales from pre-operatively to 2-year follow-up in the study cohort. According to PROM subscales, 47.8–57.6% and 25.2–38.2% achieved Minimal Clinical Important Difference and Patient Acceptable Symptom State, respectively. This study demonstrates, in PAO-treated patients, significant PROM improvements after additional hip arthroscopy. Unfortunately, only ∼50% and 30% achieved Minimal Clinical Important Difference and Patient Acceptable Symptom State, respectively.