Non-comparative Study Research Articles

Novel Clinical Practice Assessments: Informational Statements by the Musculoskeletal Tumor Society.

Musculoskeletal oncology involves rare diseases. As a result, there is a paucity of literature to guide practitioners. Studies are often clinical experience, retrospective reviews, noncomparative studies, and involve small numbers of patients. However, technological advances consistently arise in this field. This article represents the Musculoskeletal Tumor Society efforts to improve multispecialty collaboration and research credibility. It involves brief systematic reviews of novel ideas and suggests high-quality research needed to provide and standardize best practices within this field.

Systematic review of clinical effectiveness and safety of abdominal aortic aneurysm screening in men

Abstract Background Abdominal aortic aneurysm (AAA) is characterised by a bulging in the aortic wall. AAA is typically asymptomatic until aneurysm rupture, which is associated with a very high mortality rate (approximately 80%). In the context of an ageing population and increasing life expectancy, innovative approaches to early detection and intervention are needed. The aim of this review was to assess the clinical effectiveness and safety of one-time ultrasound screening for AAA in men. Methods Systematic searches were conducted in electronic databases and grey literature sources. The primary outcomes of interest were AAA-related mortality, AAA rupture, all-cause mortality, rate of surgical repair and safety. The following study designs were included: systematic reviews, randomised controlled trials (RCTs), comparative observational studies and population-based non-comparative observational studies. Results Results from a systematic review by the US Preventive Services Task Force analysed 4 population-based RCTs, showing that one-time population-based screening for AAA in men (≥ 65 years) led to significant reductions in AAA-related mortality (OR = 0.65, 95% CI: 0.57 to 0.74), AAA rupture (OR = 0.61, 95% CI: 0.54 to 0.69) and emergency surgeries (OR = 0.53, 95% CI: 95% CI: 0.44 to 0.64) at 13-15 years follow-up, relative to no screening. Separate to this systematic review an additional 24 studies reported on clinical effectiveness, safety and psychosocial harms of AAA screening. Limited evidence from these studies suggest screening was associated with a reduction in AAA-related mortality and rupture but also transient psychological distress in some cases. Conclusions One-time ultrasound screening in men ≥65 years appears to offer benefits in terms of reducing AAA ruptures and AAA-related mortality, though the balance of benefits and harms requires careful consideration. In an ageing population, AAA screening could be transformative, by reducing mortality and rupture risks. Key messages • One-time ultrasound screening for AAA in older men (≥ 65 years) can reduce AAA-related mortality and rupture. • In the context of an ageing population in Europe, AAA screening could be transformative, but benefits must be weighed against potential risks.

Clinical Outcomes of Patients with Colorectal Cancer Who Underwent Comprehensive Genomic Profiling: A Single-institution Non-comparative Prospective Observational Study

Clinical Outcomes of Patients with Colorectal Cancer Who Underwent Comprehensive Genomic Profiling: A Single-institution Non-comparative Prospective Observational Study

Importance of an Evaluation Phase When Increasing the Occlusal Vertical Dimension: A Systematic Review.

To assess whether an evaluation period is necessary for patient and clinical success when increasing the occlusal vertical dimension (OVD) for a full mouth rehabilitation. A systematic search was conducted in six databases: MEDLINE, Web of Science, Scopus, CENTRAL, VHL, and EMBASE. The eligibility criteria of this systematic review used the PICO framework to address the following research question: "In dentate adults requiring an increase in occlusal vertical dimension (OVD) (P), is an evaluation period of the new OVD (I) superior to no evaluation period (C) in terms of success (O)?" Study characteristics, survival, and success rates were extracted from each article. No language restrictions were applied. Study quality was appraised using Cochrane's Risk of Bias 2 tool and Newcastle-Ottawa Scale (NOS) according to the study design. The electronic search yielded 1188 titles after duplicates were removed. One RCT and 103 non-comparative articles were found relevant to the search question. Out of the 103 articles, 80 had an evaluation phase and 23 did not. The included RCT revealed that removable devices tended to cause chewing difficulties, unclear speech, and esthetic discomfort. Therefore, the use of a removable appliance to functionally or esthetically evaluate OVD was not indicated prior to the definitive treatment. Esthetics was the highest reported parameter preoperatively for the non-comparative studies, at 85% with an evaluation and 86% without. At present, there is lack of evidence that an evaluation period improves clinical and patient-reported outcomes when increasing OVD for full mouth rehabilitations. Thus, an increase in OVD can be successful with or without an evaluation phase. The evaluation phase helps the clinician manage patient expectations and assist with the treatment sequencing. This phase is most effective with fixed restoration, such as temporary crowns or adhesive restorations. However, there is limited evidence that this phase improves clinical or patient-reported outcomes.

Intravitreal Dexamethasone Implants for Macular Edema Secondary to Acute Retinal Necrosis

ABSTRACT Purpose To assess the effectiveness and risk of intravitreal injection of dexamethasone implants in treating macular edema (ME) secondary to acute retinal necrosis (ARN). Methods In this retrospective, noncomparative case series study, five patients who developed secondary ME after ARN and received an intravitreal dexamethasone implant injection were enrolled. The features of secondary ME on OCT and the outcomes of dexamethasone intravitreal implanting were presented. Results The mean age of the patients was 59 years (range, 51–61 years). All patients had unilateral involvement, and all 5 eyes showed mild to moderate anterior uveitis, retinal necrosis, and vasculitis. Herpes zoster virus was detected in all eyes using PCR, and timely antiviral and anti-inflammatory treatment was performed. Aqueous humor samples were negative for herpes zoster virus DNA, and resolution of viral retinitis was noted upon the occurrence of ME. Additionally, three eyes received pars plana vitrectomy with silicone oil prior to ME development. All eyes presented with intraretinal fluid, hyper-reflective foci, and impairments of the external limiting membrane/ellipsoid zone at varying degrees on OCT images. Epiretinal membrane was exhibited in 80% of eyes, but no vitreoretinal traction was detected. Subretinal fluid was visible in 60% of eyes. ME was relieved effectively in all eyes after intravitreal dexamethasone implanting. One of these patients experienced three episodes of ME. No recurrence of retinal necrosis or corticosteroid-associated ocular hypertension was observed during the follow-up period. Conclusion Intravitreal injection of dexamethasone implants can effectively alleviate ME secondary to ARN and improve visual acuity with no adverse reactions.

Effectiveness of pulpotomy in managing carious exposure in mature permanent teeth: A systematic review and meta-analysis

ObjectivesThis quantitative systematic review evaluated whether pulpotomy performed with hydraulic calcium silicate cements may be used as an alternative to root canal treatment (RCT) in mature permanent teeth with carious pulp exposure. Data sourcesA comprehensive search was conducted in PubMed, Web of Science, Scopus, and the Cochrane Library. No language restrictions were applied. The search included randomised controlled trials that compared pulpotomy to root canal treatment for managing carious exposure in mature permanent teeth. Study selectionStudies were selected based on predetermined inclusion criteria: randomised controlled trials involving mature permanent teeth with carious pulp exposure, using hydraulic calcium silicate cements for pulpotomy. Non-comparative studies, case reports, and trials involving primary or immature permanent teeth were excluded. DataData were extracted on success rates, clinical outcomes, follow-up periods, pain profiles, and potential complications. A meta-analysis was performed, revealing no statistically significant differences in success rates between pulpotomy and RCT. Both interventions demonstrated success rates exceeding 90 % at one-year and two-year follow-up periods. Pain profiles consistently showed lower post-operative pain intensity in the pulpotomy group compared to the RCT group during the first week. Potential complications, such as non-responsive pulp and difficulties in determining pulp vitality, were reported more frequently in the pulpotomy group. ConclusionsPulpotomy with bioactive hydraulic calcium silicate cements shows comparable success rates to RCT in managing carious pulp exposure in mature permanent teeth. The results suggest pulpotomy as a viable, less invasive alternative to RCT, particularly in cases where preservation of pulp vitality is paramount. Clinical significanceThis systematic review highlights pulpotomy as a less invasive and cost-effective alternative to root canal treatment in mature permanent teeth. With comparable success rates and lower post-operative pain, pulpotomy offers a promising approach to managing carious exposure and preserving tooth vitality.

Diagnostic Utility of Copeptin in Pediatric Patients with Polyuria-Polydipsia Syndrome: A Systematic Review and Meta-Analysis

Pediatric patients with polyuria polydipsia syndrome (PPS) represent a diagnostic challenge for clinicians because of the technical difficulties in performing the gold standard water deprivation test (WDT). Copeptin, a stable biomarker representing the C-terminal portion of the polypeptide chain of the antidiuretic hormone, is a reliable diagnostic tool. To assess the diagnostic accuracy of baseline copeptin dosing, arginine/hypertonic saline copeptin stimulation tests, and WDT. This study aimed to establish the diagnostic utility of copeptin in pediatric patients by distinguishing between central diabetes insipidus, nephrogenic diabetes insipidus, and primary polydipsia. Comparative and non-comparative primary studies published between January 2018 and August 2024 focusing on children were searched and included in PubMed, Cochrane Library, Web of Science, ScienceDirect, Scopus, and Google Scholar. The QUADAS-2 tool was used to assess the risk of bias and applicability. Meta-analyses used fixed effects models because of low heterogeneity and the HSROC model. Eleven studies were included with an overall low bias and no significant applicability concerns. The mean pooled sensitivity = 0.98 (95% CI: 0.936–1.025), pooled specificity = 0.947 (95% CI: 0.920–0.973), and AUC = 0.972 (95% CI: 0.952–0.992), indicating excellent diagnostic accuracy. Stimulation methods for copeptin dosing represent an effective and less invasive diagnostic test for children with PPS, and future development of standard copeptin testing protocols is needed.

Prospective Evaluation of Clinical and Patient-Reported Outcomes Following Contralateral Implantation of an Extended Depth of Focus (EDOF) and Hybrid EDOF-Multifocal IOL.

To evaluate clinical outcomes following contralateral implantation of a diffractive extended depth of focus (EDOF) and a hybrid EDOF-multifocal intraocular lens (IOL) with a violet filter in a U.S.-based population. In this prospective, non-comparative study, 60 eyes of 30 patients aged 40 years and older underwent bilateral cataract surgery and implantation of a DXR00V IOL (Tecnis Symfony OptiBlue) in the dominant eye and a DFR00V (Tecnis Synergy) IOL in the non-dominant eye. Outcome measures included uncorrected (UDVA) and corrected (CDVA) distance visual acuity, distance-corrected intermediate (DCIVA, 66 cm), near and very near visual acuity (DCNVA, 40 and 33 cm), and patient-reported outcomes. At 6 months postoperatively, binocular mean UDVA and CDVA were -0.10 ± 0.07 and -0.11 ± 0.05 logarithm of the minimum angle of resolution (logMAR), respectively. The mean DCIVA was 0.26 ± 0.08 logMAR in the DXR00V eyes and 0.23 ± 0.06 logMAR in the DFR00V eyes. The mean DCNVA at 40 and 33 cm were 0.28 ± 0.12 and 0.30 ± 0.15 logMAR, respectively, in the DXR00V eyes and 0.07 ± 0.08 and 0.07 ± 0.10 logMAR, respectively, in the DFR00V eyes. The mean binocular DCIVA and DCNVA at 33 and 40 cm were 0.18 ± 0.05, 0.06 ± 0.08, and 0.06 ± 0.07 logMAR, respectively. The percentages of patients achieving spectacle independence at far, intermediate, and near distances were 100%, 100%, and 81%, respectively. Contralateral implantation of the diffractive EDOF and a hybrid EDOF-multifocal IOL yielded excellent binocular visual acuity at all distances, as well as high patient satisfaction and functional performance on visual tasks. [J Refract Surg. 2024;40(10):e699-e705.].

To evaluate the outcome of external dacryocystorhinostomy without flaps in the cases of adult chronic dacryocystitis

: To evaluatethe efficacy of external dacryocystorhinostomy without mucosal flaps in adult population.: In this prospective, non-comparative interventional study 50 adult cases with epiphora due to chronic dacryocystitis was selected. All patients were managed with external dacryocystorhinostomy without anastomosis of the nasal and lacrimal mucosal flaps and success rate was evaluated by relief of epiphora and lacrimal syringing on day 1, day 7, and then after 1 month, 3 months & 6 months subsequently.: Total number of cases operated were 52 eyes with female preponderance (38 cases 78%), with left laterality (76%) with success rate of 92%. With mean operating time 27.71min. : External dacryocystorhinostomy without mucosal flaps is a better method of managing the cases of chronic dacryocystitis with higher success rate with minimal skill and time consumption.

The Safety and Feasibility of Ambulatory Minimally-Invasive Partial Nephrectomy: A Systematic Review and Meta-Analysis.

Emerging evidence supports the use of minimally invasive partial nephrectomy (MIPN) in ambulatory settings. We conducted a systematic review and meta-analysis to evaluate differences in perioperative characteristics, complication/readmission rates and satisfaction/cost data between ambulatory and standard-length discharge (SLD) MIPN. This study was prospectively registered in PROSPERO (CRD42023429854). A systematic literature search of PubMed, Embase, and Web of Science databases was conducted, including studies comparing ambulatory MIPN versus SLD MIPN for patients with renal masses. Studies were assessed for quality using the Methodological Index for Non-Randomized Studies score. Meta-analysis was performed for comparative studies, and non-comparative studies were included narratively. Eleven studies were included with a pooled population of 20,575 patients, of which 1,419 (7%) had a length of stay less than 1 day and were considered the ambulatory group. There were no significant differences in the total complication rates (RR: 0.50, 95% CI: 0.24, 1.04; p = 0.06) or 30-day readmission rates (RR: 0.87, 95% CI: 0.56, 1.35; p=0.53) between the ambulatory and SLD groups. There were fewer > 3 Clavien-Dindo complications in the ambulatory group (RR: 0.34, 95% CI: 0.19, 0.59; p = 0.0002). Few studies reported average healthcare cost and patient satisfaction. In appropriately selected patients, ambulatory MIPN is safe and feasible. Future studies are needed to quantify cost and patient satisfaction differences and further identify appropriate patient selection criteria for ambulatory MIPN. No funding.

Hemispheric asymmetries in borderline personality disorder: a systematic review.

Borderline personality disorder (BPD) is characterized by increased mood reactivity and affective instability. Since core structures involved in emotion processing, such as the amygdala, demonstrate strong lateralization, BPD is an interesting target for laterality research. So far, a systematic integration of findings on lateralization in BPD is missing. Therefore, we systematically reviewed studies published until February 2024 in PubMed, Web of Science, and PsycInfo databases that measured hemispheric asymmetries and behavioral lateralization in patients with BPD. Inclusion criteria were (a) diagnosis of BPD and (b) results on hemispheric or behavioral asymmetries. Specifically for neuroimaging studies, hemispheres need to be assessed separately. Review articles and studies with disorders other than BPD were excluded. Risk of bias was assessed with the Newcastle Ottawa Scale for non-randomized, non-comparative intervention studies. A total of 21 studies met the inclusion criteria. Thirteen studies investigated structural hemispheric asymmetries, five functional hemispheric asymmetries, two examined handedness, and one studied hemispheric asymmetry in visuospatial attention. Overall, studies examining structural asymmetries in BPD report bilateral volume reduction in the amygdala and hippocampus but a right-sided reduction in the orbitofrontal cortex. For functional lateralization, asymmetrical de/activation patterns in the default mode network in BPD and reduced right-frontal asymmetry were evident. Also, studies indicate a trend towards increased non-right-handedness in BPD. Risk factors for BPD, such as childhood abuse, may play a crucial role in the development of structural and functional alterations. However, the generalization of results may be limited by small sample sizes and varying study designs.

227TiP A phase II, open label, randomized, non-comparative cohorts study of adjuvant atezolizumab or atezolizumab plus tiragolumab in solid tumors with resectable disease with intermediate-high risk of recurrence and high tumor mutational burden (TMB-H) or microsatellite instability (MSI-H)

227TiP A phase II, open label, randomized, non-comparative cohorts study of adjuvant atezolizumab or atezolizumab plus tiragolumab in solid tumors with resectable disease with intermediate-high risk of recurrence and high tumor mutational burden (TMB-H) or microsatellite instability (MSI-H)

New Comprehensive Score for Predicting Difficulties in Revision Total Hip Arthroplasty

BackgroundRevision total hip arthroplasty (THA) can be complex, and assessing possible difficulties is important to predict the operative time. No simple score for predicting difficulties has been assessed prospectively. We therefore developed an original score for the pre-operative evaluation of extraction and reconstruction difficulties. The objectives of this prospective study were to (1) assess correlations between score values and operative time, (2) determine whether the score predicted the need for revision implants and/or filling material, (3) determine whether the score predicted intra-operative and post-operative complications, and (4) evaluate the inter-observer and intra-observer reproducibility of the score. HypothesisThe score is reproducible and correlates well with the operative time, thereby allowing prediction of this parameter before surgery. Material and methodsA prospective study of 103 revision THA procedures performed between March 2018 and August 2023 was conducted. The primary outcome was operative time and the secondary outcomes were use of a revision implant, use of filling material, and intra-operative and post-operative complications. The score was determined by four observers to allow evaluation of inter-observer agreement. Intra-observer agreement was assessed by having one of the observers determine the score a second time after inclusion of the last patient. The score has a maximum value of 20 and allows classification of the procedure as very difficult, difficult, and moderately difficult. ResultsMean operative time correlated with the score value: 136.0 ± 33.9 min in the very difficult group, 102.0 ± 34.8 min in the difficult group, and 75.4 ± 65.5 min in the moderately difficult group (p = 0.0002). The score predicted the use of a reinforcement ring (40 procedures: 12/17 [70%], 11/25 [44%], and 17/61 [28%] in the very difficult, difficult, and moderately difficult groups, respectively; p = 0.01) and of a long stem (20 procedures: 8/17 [47%], 7/25 [28%], and 5/61 [8%] patients in the very difficult, difficult, and moderately difficult groups, respectively; p < 0.001). The score did not predict the use of filling material (42 procedures: 10/17 [59%], 9/25 [36%], and 23/61 [37%] in the very difficult, difficult, and moderately difficult groups, respectively; p = 0.250). The score predicted both intra-operative complications (5/17 [29%], 4/25 [16%], and 4/61 [6%] procedures in the very difficult, difficult, and moderately difficult groups, respectively; p = 0.028) and post-operative complications (4/17 [23%], 0/25 [0%], and 6/61 [9%] in the very difficult, difficult, and moderately difficult groups, respectively; p = 0.15). Inter-observer agreement was strong according to Landis-Koch criteria, with kappa values ranging from 0.70 to 0.79 [0.57–0.90]. The kappa value for intra-observer agreement was 0.74 [0.63–0.85]. DiscussionThis score predicts surgical difficulties by adding criteria to bone destruction, in contrast to widely used classifications for revision THA. Moreover, the score is reproducible and predicts the operative time, thus potentially playing an important role during pre-operative planning. Level of evidenceIV; prospective observational non-comparative study

The burden of iatrogenic obstetric fistulas in Sub-Saharan Africa: Systematic review and meta-analysis protocol.

Obstetric fistulas are abnormal open connection(s) between the vagina and the urinary tract or the rectum resulting from tragic injuries sustained by mothers during childbirth that lead to urine and/or faecal incontinence. Due to the rapidly growing middle class in sub-Saharan Africa (SSA) and the corresponding quest for hospital delivery and caesarean section, surgery-related (iatrogenic) obstetric fistulas are on the rise. Worryingly, there is scanty data on surgery-related fistulas. This review aims to collate empirical evidence on the magnitude of iatrogenic obstetric fistulas in SSA, generate country-specific data and explore factors that influence obstetric surgery-related fistulas. All relevant databases, PubMed, LILACS, CINAHL, SCOPUS and Google Scholar will be searched from 1st January 2000 to 31st March 2024 using search terms developed from the major concepts in the title without restrictions by language. The Cochrane Library, African Journals Online, Data Base of African Thesis and Dissertations Including Research (DATAD-R D Space) and preprint repositories will also be searched. Reference lists of relevant studies will be searched and experts in the field will be contacted for additional (unpublished) studies. The search output will be exported to Endnote where duplicate studies will be removed. The deduplicated studies will be exported to Rayyan where study screening and selection will be conducted. At least two authors will independently select studies, extract data and assess quality in the included studies using pretested tools. Disagreements between reviewers will be resolved through discussion. Data analysis will be performed with RevMan 5.4. Comparative binary outcomes will be reported as odds ratio (OR) or risk ratio (RR) and for continuous outcomes, mean difference and standard deviations (SDs) will be used. Non-comparative studies will be analysed as weighted proportions. Heterogeneity between studies will be assessed graphically and statistically, and where a significant level is detected, the random-effects model meta-analysis will be performed. All estimates will be reported with their 95% confidence intervals (CIs). Where data permit, we will conduct subgroup and sensitivity analyses to test the robustness of the estimates on key quality domains. The overall quality of the evidence will be assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation). This systematic review and meta-analysis uses rigorous methods and best practices to attempt to collate all empirical evidence and estimate country-specific proportions of iatrogenic (surgery-related) fistulas among obstetric fistula patients across countries in SSA. This review will explore context-specific variables, provide insights into their impact and relate them to the type and experience of personnel performing the obstetric procedures that lead to obstetric fistulas. The findings of the full review are expected to inform the development of national and regional Training Programs for Medical Officers, support the development of a consensus "minimum acceptable standard of care" and inform quality assurance standards for clinicians involved in the provision of surgical obstetric care.

Analysis of Research Trends in Ultrasound-Guided Acupuncture and Dry-Needling: A Scoping Review.

Background: This study aimed to summarize the current status of research on ultrasound-guided acupuncture and dry-needling treatment and the specific treatment methods applied to patients. Methods: A scoping review was conducted, surveying three English databases (PubMed, Embase, and the Cochrane Library) for studies published up to May 2024. All studies related to ultrasound-guided acupuncture and dry-needling treatment were considered. Literature was selected using selection and exclusion criteria, and extracted and organized using EndNote. Results: A total of 107 eligible studies were included. Among the 107 studies, non-comparative studies accounted for the largest proportion (n = 47, 43.9%), followed by randomized controlled trials (RCTs; n = 41, 38.3%). Diseases of the musculoskeletal system or connective tissue (15 diseases of the musculoskeletal system or connective tissue) accounted for most (n = 48, 55.8%) of the 86 diseases studied, followed by symptoms, signs, or clinical conditions not otherwise classified (n = 17, 19.8%). Conclusions: Ultrasound-guided acupuncture and dry-needling have been actively studied and applied for the treatment of various diseases. However, higher-quality studies are needed for further applications in research and clinical practice.

A Systematic Review and Meta-Analysis of Synthetic Mesh Outcomes in Alloplastic Breast Reconstruction.

Mesh implants are frequently employed in alloplastic breast reconstruction. Notably, no mesh to date has FDA approval for this indication. Several synthetic meshes have been introduced with heterogeneous properties and outcomes. This study aims to systematically review synthetic mesh use in alloplastic breast reconstruction, describe rates of short-term complications, and analyze these outcomes in reports comparing synthetic and biologic meshes. The authors hypothesized data from comparative and noncomparative studies would show no significant differences between synthetic and biological meshes. The authors conducted a systematic literature review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Thirty-one studies reporting the use of synthetic mesh and clinical outcomes were included. Eight studies directly comparing synthetic mesh and biological mesh were meta-analyzed for relative risk (RR). Nineteen noncomparative studies were analyzed for meta-rates. Outcomes, including seroma, infection, reoperation, and explant, were assessed on a per-breast basis. Resultant models were challenged for sensitivity and bias. Meta-analysis of comparative studies demonstrated no difference in the risk of infection with synthetic mesh (RR = 0.53; 95% CI [0.26-1.10]), but a reduced risk of reoperation (RR = 0.54; 95% CI [0.33-0.89]) or explant (RR = 0.43; 95% CI [0.21-0.87]). Meta-analysis of noncomparative studies demonstrated rates of seroma = 3%; 95% CI [1%-6%], infection = 4%; 95% CI [3%-6%], reoperation = 10%; 95% CI [7%-13%], and explant = 3%; 95% CI [2%-5%]). Studies comparing synthetic and biologic meshes demonstrated noninferiority of synthetic in all outcomes assessed. Noncomparative studies demonstrated rates of seroma, infection, reoperation, and explant similar to literature values for biological mesh.

No test medical abortion - a review of the evidence on selective use of preabortion testing.

The last decade has seen a cascade of different telemedicine models for medical abortion (MA) being tested and implemented. Among these service delivery models is the 'no-test' MA model, in which care is provided remotely and eligibility for the MA is based on history alone. The purpose of this review is to provide an overview of the existing evidence for no-test MA. The evidence base for no-test MA relies heavily on cohort and noncomparative studies predominantly from high resource settings. Recent findings indicate that no-test MA is safe, effective, and highly acceptable. Diagnoses of ectopic pregnancy and underestimation of gestational age were rare. Identified advantages included shortening time to access MA and mitigating access barriers such as cost, and geographical barriers. Abortion seekers valued omitting the ultrasound citing reasons such as privacy concerns, costs, more flexibility, and control. The impacts of no-test MA on unscheduled postabortion contacts and visits and on contraceptive use were unclear due to limited evidence. No-test MA can be provided to complement other care pathways including those with some or no in-person care. Further research is needed to allow for widespread adoption of no-test MA and scale-up in a variety of contexts, including low-resource settings.

Is Ocular Safety in Orthopaedics Overlooked? A Systematic Review of Annual Ocular Radiation Exposure and Protective Measures.

Intraoperative fluoroscopy is increasingly common in orthopaedics, although recent guidelines have reduced the maximum recommended exposure to 20 mSv annually. A systematic review of the literature was conducted to comprehensively assess current adherence to exposure guidelines, identify practice settings at increased risk for exposure, and determine the best practices and personal protective equipment for ocular radiation risk mitigation. In this systematic review we asked: (1) Is the annual amount of eye irradiation received by orthopaedic surgeons below the recommended limit of 20 mSv? (2) What is the effectiveness of leaded glasses in reducing the eye's exposure to radiation? (3) Which imaging setups and operative techniques reduce ocular irradiation? PubMed, Medline, EBSCOhost, and Google Scholar were queried on September 28, 2023, to identify studies assessing intraoperative ocular radiation exposure among orthopaedic surgeons. Studies that measured radiation in or around the eye (such as the bridge of the nose or eyebrows) during orthopaedic procedures were included. Exclusion criteria were duplicate studies, studies that only estimated eye radiation based on the radiation dose recorded at parts of the body distant from the eyes, nonoriginal research, case reports, and articles without full-text English versions available. A total of 393 unique articles were retrieved, and after title, abstract, and full-text screening, 23 dosimetry studies were included, comprising 12 prospective observational studies, 7 phantom models, 1 cadaver model, 2 observational studies, and 1 randomized control trial. Risk of bias was determined via the Methodological Index for Nonrandomized Studies (MINORS) tool. Study quality was generally good to excellent, with noncomparative studies having a mean MINORS score of 14 ± 0 of 16 and comparative studies achieving a mean score of 19 ± 1 of 24, with higher scores representing better study quality. Due to extensive heterogeneity in study design, a meta-analysis was not conducted, with the results rather presented as a narrative summary of key findings. The vast majority of surgeons conducting a variety of orthopaedic and traumatologic procedures were not exposed to a hazardous level of eye irradiation annually, but surgeons who perform a high volume of fluoroscopy-intensive procedures may exceed guidelines. Leaded eyeglasses reduced eye radiation by about 90%, with sport wrap-around glasses offering better shielding than alternatives, although leaded glasses overall were largely underutilized. Positioning mini C-arms in the standard vertical configuration was shown to provide up to a 13-fold decrease in radiation exposure compared with inverted configuration, while standing perpendicular to the fluoroscope further reduced eye irradiation. We found that orthopaedic surgeons who perform a high volume of fluoroscopy-intensive procedures may be at risk of exceeding recommendations on annual radiation exposure, although exposure can be mitigated through various simple strategies. In particular, this analysis found that the use of sport wrap-around leaded glasses, positioning of mini-C arms in the standard vertical configuration, and standing perpendicular to the fluoroscope provide the most effective means of limiting ocular radiation exposure. As ophthalmic radiation exposure presents a potentially important occupational health hazard to orthopaedic surgeons, further investigations of radiation exposure specific to high-volume, fluoroscopy-intensive orthopaedic practices and long-term ophthalmic outcomes will help determine the extent of the potential harm posed by frequent exposure to intraoperative radiation over the span of a career. Level III, therapeutic study.

Gynaecological cancer surveillance for women with Lynch syndrome: systematic review and cost-effectiveness evaluation.

Lynch syndrome is an inherited condition which leads to an increased risk of colorectal, endometrial and ovarian cancer. Risk-reducing surgery is generally recommended to manage the risk of gynaecological cancer once childbearing is completed. The value of gynaecological colonoscopic surveillance as an interim measure or instead of risk-reducing surgery is uncertain. We aimed to determine whether gynaecological surveillance was effective and cost-effective in Lynch syndrome. We conducted systematic reviews of the effectiveness and cost-effectiveness of gynaecological cancer surveillance in Lynch syndrome, as well as a systematic review of health utility values relating to cancer and gynaecological risk reduction. Study identification included bibliographic database searching and citation chasing (searches updated 3 August 2021). Screening and assessment of eligibility for inclusion were conducted by independent researchers. Outcomes were prespecified and were informed by clinical experts and patient involvement. Data extraction and quality appraisal were conducted and results were synthesised narratively. We also developed a whole-disease economic model for Lynch syndrome using discrete event simulation methodology, including natural history components for colorectal, endometrial and ovarian cancer, and we used this model to conduct a cost-utility analysis of gynaecological risk management strategies, including surveillance, risk-reducing surgery and doing nothing. We found 30 studies in the review of clinical effectiveness, of which 20 were non-comparative (single-arm) studies. There were no high-quality studies providing precise outcome estimates at low risk of bias. There is some evidence that mortality rate is higher for surveillance than for risk-reducing surgery but mortality is also higher for no surveillance than for surveillance. Some asymptomatic cancers were detected through surveillance but some cancers were also missed. There was a wide range of pain experiences, including some individuals feeling no pain and some feeling severe pain. The use of pain relief (e.g. ibuprofen) was common, and some women underwent general anaesthetic for surveillance. Existing economic evaluations clearly found that risk-reducing surgery leads to the best lifetime health (measured using quality-adjusted life-years) and is cost-effective, while surveillance is not cost-effective in comparison. Our economic evaluation found that a strategy of surveillance alone or offering surveillance and risk-reducing surgery was cost-effective, except for path_PMS2 Lynch syndrome. Offering only risk-reducing surgery was less effective than offering surveillance with or without surgery. Firm conclusions about clinical effectiveness could not be reached because of the lack of high-quality research. We did not assume that women would immediately take up risk-reducing surgery if offered, and it is possible that risk-reducing surgery would be more effective and cost-effective if it was taken up when offered. There is insufficient evidence to recommend for or against gynaecological cancer surveillance in Lynch syndrome on clinical grounds, but modelling suggests that surveillance could be cost-effective. Further research is needed but it must be rigorously designed and well reported to be of benefit. This study is registered as PROSPERO CRD42020171098. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129713) and is published in full in Health Technology Assessment; Vol. 28, No. 41. See the NIHR Funding and Awards website for further award information.

Malignant glaucoma treated by low-dose laser cycloplasty: a 1-year multicenter prospective non-comparative study.

To report a one-year clinical outcomes of low-dose laser cycloplasty (LCP) among malignant glaucoma patients. In this prospective, multicenter, non-comparative clinical study, participants with malignant glaucoma were recruited and underwent LCP at eight ophthalmic centers in China. Patients were followed up at 1wk, 1, 3, 6, and 12mo. Intraocular pressure (IOP), number of glaucoma medications, anterior chamber depth (ACD), and complications were recorded. Anatomical success was defined as the reformation of the anterior chamber based on slit-lamp biomicroscopy. Recurrence was defined by the presence of a shallow or flat anterior chamber after initial recovery from treatment. A total of 34 eyes received LCP. Mean IOP and medications decreased from 36.1±11.5 mm Hg with 3.3±1.5 glaucoma medications pre-treatment to 20.9±9.8 mm Hg (P<0.001) with 2.9±1.6 medications (P=0.046) at 1d, and 17.4±6.7 mm Hg (P<0.001) with 1.3±1.7 medications (P<0.001) at 12mo. The ACD increased from 1.1±0.8 mm at baseline to 1.7±1.0 mm and to 2.0±0.5 mm at 1d and 12mo, respectively. A total of 32 (94.1%) eyes achieved initial anatomical success. During follow-up, 2 (5.9%) eyes failed and 8 (23.5%) eyes relapsed, yielding a 12-month anatomical success rate of 64.3%. Complications including anterior synechia (8.82%), choroidal/ciliary detachment (5.88%) and hypopyon (2.94%) were observed within 1wk. LCP is simple, safe, and effective in reforming the anterior chamber in malignant glaucoma.