Nonrandomized Comparative Study Research Articles

A systematic review and meta-analysis of morbidity and pancreatic fistula after distal pancreatectomy with versus without prophylactic intra-abdominal drainage.

The omission of a prophylactic intra-abdominal drainage has been under debate in pancreatic surgery due to the high risk of complications and especially of postoperative pancreatic fistula (POPF). Recently, the second randomized controlled trial (RCT) and two propensity score-matched comparative studies assessing risks and benefits of a no-drainage policy versus prophylactic drainage after distal pancreatectomy (DP) have been published. This systematic review with meta-analysis provides an updated summary of the available evidence on this topic. RCTs and non-randomized comparative studies (NCS) investigating outcomes of no drainage versus drainage after DP were searched systematically in MEDLINE, Embase and CENTRAL. Random effects meta-analyses were performed, and the results presented as weighted odds ratios (OR) or mean differences (MD) with their corresponding 95% confidence intervals (c.i.). Subgroup analyses were performed to account for inter-study heterogeneity between RCTs and NCS. Two RCTs and six NCS with a total of 3,610 patients undergoing DP were included of whom 1,038 (28.8%) patients did not receive prophylactic drainage. A no-drainage policy was associated with significantly lower risks of POPF (OR 0.38, 95% c.i. 0.25-0.56; P<0.00001), reduced major morbidity (OR 0.64, 95% c.i. 0.47-0.89; P=0.008), less reinterventions (OR 0.70, 95% c.i. 0.52-0.95; P=0.02) and fewer readmissions (OR 0.69, 95% c.i. 0.54-0.88; P=0.003) as well as shorter length of hospital stay (MD -1.74, 95% c.i. -2.70- -0.78; P=0.0004). Subgroup analyses including only RCTs confirmed benefits of the no-drainage policy. A no-drainage policy is associated with reduced POPF and morbidity and can therefore be recommended as standard procedure in patients undergoing DP.

Surgical outcomes of XEN45 implantation, trabeculectomy vs. penetrating canaloplasty in open-angle glaucoma: A non-randomized comparative study.

Surgical outcomes of XEN45 implantation, trabeculectomy vs. penetrating canaloplasty in open-angle glaucoma: A non-randomized comparative study.

Robotic pancreaticoduodenectomy in patients with overweight or obesity: a meta-analysis protocol

IntroductionThe prevalence of overweight or obesity among patients undergoing pancreaticoduodenectomy is on the rise. The utilisation of robotic assistance has the potential to enhance the feasibility of performing minimally invasive...

No increased complication rate with the use of soft tissue quadriceps tendon autograft for primary ACL reconstruction – a systematic review

BackgroundThe autograft of choice for anterior cruciate ligament reconstruction (ACLR) remains debateable. Recently there has been increased popularity of soft tissue quadriceps tendon (s-QT) autograft due to less donor site morbidity, reduced anterior knee pain and comparable re-operation and complication rates. The aim of this review was to analyse functional outcomes of primary ACLR using s-QT in adult population without the bone plug and to report its complication profile against other autografts. Patient and methodsThis systematic review was performed in accordance with PRISMA guidelines and a review of literature was conducted on four online databases (Medline, EMBASE, Cochrane and Google Scholar). Clinical studies reporting on patients undergoing primary ACLR with s-QT autograft or in comparison to BPTB or HS autografts with a minimum of 6 months follow-up were included. The studies were inclusive of only all soft tissue QT autograft regardless of the implants or fixation method used. Critical appraisal of studies was conducted using the Methodological Index for Non-Randomized Studies (MINORS) tool. ResultsFourteen studies were eligible. There were three randomised control studies (RCT) and 11 non-randomised comparative studies with 1543 patients who underwent ACLR. 682 underwent s-QT, 498 had hamstring tendon (HT) and 174 had bone-patellar tendon-bone (BPTB). 60% (n = 930) were males and mean follow up was 23.6 months (6–65). Eight studies reported post-operative patient reported outcome measures (PROMs). The mean International Knee Documentation Committee (IKDC) score was 91.5 ± 15.1 whereas mean Lysholm score was 90 ± 3.9. Five studies reported on laxity with mean anterior tibial translation (ATT) of 1.28 ± 1.09 mm. Overall complication rate of s-QT ACLR was 6% with 3% graft failure, 0.52% arthrofibrosis, 0.2% infection, 0.75% revision ACLR. There was no significant difference in functional outcome scores, knee stability and range of motion (ROM) between s-QT, HT and BPTB. Conclusions-QT for ACLR has a comparable functional outcome, laxity, failure and with overall graft failure rate of 3%. Level of evidenceIII; Systematic review and meta-analysis.

Does the Application of Topical Vancomycin Reduce Surgical Site Infections in Spine Surgery? A Meta-analysis of Randomized Controlled Trials.

Surgical site infections (SSIs) represent a major challenge in spine surgery, leading to severe morbidity, mortality, and increased costs. The local application of antibiotics, particularly vancomycin, has emerged as a potential strategy. Individual randomized controlled trials (RCTs) have disagreed about the efficacy of topical vancomycin in preventing SSIs after spine surgery, and so a meta-analysis that pools data from those RCTs might be helpful to inform clinicians' decisions on the topic. This meta-analysis of RCTs asked: Does intrawound topical vancomycin reduce the risk of (1) SSIs, (2) deep SSIs, and (3) superficial SSIs in patients undergoing spine surgery? PubMed, Cochrane, and Google Scholar (pages 1-20) were searched up through March 13, 2024 (search performed on March 13, 2024). Inclusion criteria consisted of English or non-English-language RCTs comparing the implementation of topical vancomycin in spine surgery to its nonuse and assessing its efficacy in preventing SSI, while exclusion criteria consisted of nonrandomized comparative studies, single-arm noncomparative studies, comparative studies based on national databases or from the same center as other included studies, studies posted to preprint servers, studies reporting incomplete/nonrelevant outcomes, and studies adding another SSI preventive measure. The studies were assessed using the Cochrane Risk of Bias tool. Heterogeneity was evaluated by Q tests and I2 statistics. We used a random-effects model when considerable heterogeneity was observed (all SSIs, deep SSIs); otherwise, a fixed-effects model was used (all SSIs subanalysis, superficial SSIs). Furthermore, the fragility index was calculated for each of the assessed outcomes when there was no difference between the two groups to assess how many patients were needed to experience the outcomes for a difference to become present. The studied outcomes were the risks of SSIs, deep SSIs, and superficial SSIs. Deep SSIs were defined by the included trials as SSIs underneath the fascia, otherwise they were considered superficial. Six RCTs representing a total of 2140 patients were included, with 1053 patients in the vancomycin group and 1087 in the control group. Using an alpha of 0.05, our meta-analysis had 80% power to detect a risk difference of 1.5% for the primary outcome between patients who did and did not receive vancomycin. The age of the patients in the vancomycin group ranged from 37 to 52 years, while the age in the control group ranged from 34 to 52 years. The surgical procedures consisted of both instrumented and noninstrumented spinal procedures. Overall, the risk of bias in the included studies was either low or unclear, with none of the studies having a high risk of bias in any of the assessed categories (selection bias, performance bias, detection bias, attrition bias, and reporting bias). We found no difference in the risk of SSI between the vancomycin and control groups (3.0% [32 of 1053] versus 3.9% [42 of 1087], relative risk 0.74 [95% CI 0.35 to 1.57]; p = 0.43). Ten additional patients (4.8% infection risk) in the control group would need to experience an SSI for a difference to be observed between the two groups. We found no difference in the risk of deep SSI between the vancomycin and control groups (1.8% [15 of 812] versus 2.7% [23 of 860], relative risk 0.69 [95% CI 0.24 to 2.00]; p = 0.50). Seven additional patients (3.5% infection risk) in the control group would need to experience a deep SSI for a difference to be observed between the two groups. We found no difference in the risk of superficial SSI between the vancomycin and control groups (1.0% [6 of 620] versus 1.4% [9 of 662], relative risk 0.68 [95% CI 0.25 to 1.89]; p = 0.46). Seven additional patients (2.4% infection risk) in the control group would need to experience a superficial SSI for a difference to be observed between the two groups. This meta-analysis of randomized trials examining use of topical vancomycin in spine surgery failed to show efficacy in reducing infection, and thus we do not recommend routine use of topical vancomycin for this indication. Future large-scale trials would be needed if surgeons believe that between-group differences smaller than those for which we were powered here (this meta-analysis had 80% power to detect a between-group difference of 1.5% in infection risk) are clinically important, and large database surveys may be informative in terms of assessing for postoperative adverse events associated with the use of vancomycin powder. Level I, therapeutic study.

Primary care-based interventions for secondary prevention of opioid dependence in chronic non-cancer pain patients on pharmaceutical opioids: systematic review.

Globally almost one third of adults with chronic non-cancer pain (CNCP) are prescribed opioids. Prevention of opioid dependence among these patients is a public health priority. Synthesise the evidence on the effectiveness of primary care-based interventions for secondary prevention of opioid dependence in CNCP patients on pharmaceutical opioids. Systematic review of randomised controlled trials (RCTs) and comparative non-randomised studies of interventions from high-income countries. We searched five databases for studies on non-tapering secondary prevention interventions such as tools for predicting dependence, screening tools for early recognition of dependence, prescribing/medication monitoring, and specialist support. We examined multiple outcomes, including reduction in opioid dosage. Primary analyses were restricted to RCTs with data synthesised using an effect direction plot. Risk of bias was assessed using the Cochrane risk of bias (RoB2) tool. Of 7,102 identified reports, 18 studies were eligible (8 RCTs). Most used multiple interventions/components. Of the seven RCTs at low risk of bias or 'some concerns', five showed a positive intervention effect on at least one relevant outcome, four of which included a nurse care manager and/or other specialist support. The remaining two RCTs showed no positive effect of automated symptom monitoring and optimised analgesic management by a nurse care manager/physician pain specialist team, or of a mobile opioid management app. We identify a clear need for further adequately powered high quality studies. The conclusions that can be drawn on intervention effectiveness are limited by the sparsity and inconsistency of available data.

Management of Massive Irreparable Posterosuperior Cuff Tears: A Systematic Review for Clinical &amp; Functional &amp; Radiological Outcomes

Abstract Background The management of massive irreparable cuff tears (MIRCT) remains a highly controversial subject with many possible surgical and non-surgical interventions and no clear evidence regarding the most effective and beneficial intervention. Different management options include: conservative management, partial repair, tendon transfer, superior capsular reconstruction, subacromial spacer insertion, reverse total shoulder arthroplasty (RTSA). Aim of the Work The aim of this systematic review is to compare the various methods of management of posterosuperior cuff tears without arthropathy to reach the most effective and sustainable mode of management. Patients and Methods A randomized controlled trial, non-randomized clinical trials, prospective and retrospective comparative cohort studies and case series. We will exclude cross-sectional studies, case reports and literature not in English. Results There is no high quality evidence on management of MIRCT. There was no Level I or II evidence. We included 69 papers that studied different modalities of management of MIRCT, 31 of level III and the remaining were of level IV evidence. Consequently, it’s still difficult to recommend one method of management over the other regarding the management of irreparable cuff tears. Patient age, demands, expectations, thorough clinical examination, surgeon experience and preference are still a major deciding factor when choosing and appropriate method. Conclusion Due to the unavailability of high-quality clinical studies available for guiding management of irreparable MRCT, it is consequently not possible to recommend for or against any specific treatment strategy. Rather, clinical experience, patient factors, patient expectations, and rotator cuff tear characteristics should guide clinical decision-making. Physical therapy compared to surgical treatments may have inferior outcomes. Standardized data collection, reporting and terminology are key to enhancing the quality of evidence-based medicine.

P-648 How often does elevated progesterone occur? A systematic review

Abstract Study question What is the incidence of elevated serum progesterone level during the follicular phase in fresh and frozen ART cycles? Summary answer The incidence of elevated progesterone levels varies widely during the follicular phase in both fresh and frozen ART cycles. What is known already Progesterone monitoring is often performed for the optimization of ART cycle. Elevated progesterone (EP) noted during ovarian stimulation can lead to cycle cancellation and the implementation of a freeze all strategy as EP is associated with lower pregnancy rates. The introduction of GnRH analogues did not seem to prevent EP. In frozen embryo transfer (FET) cycles, EP can be present even without gonadotropin commencement. Various thresholds have been used to define EP and the incidence of EP reported in the literature varies. Study design, size, duration A systematic search of the following electronic databases: EMBASE, MEDLINE, CINAHL and PubMed identified non-randomised comparative cohort studies between the year 2000 to 2022. The following keywords progesterone, assisted reproductive technique and pregnancy outcomes and their respective variants were used. Study selection was performed following initial screen of the titles and abstracts. The full manuscripts were examined for compliance with the inclusion criteria and studies eligible for inclusion in the review were selected. Participants/materials, setting, methods PICOS study protocol was used. We included studies reporting per woman data of women undergoing fresh IVF/ICSI cycles (with controlled ovarian stimulation) and FET cycles (natural or medicated), with extractable data on pregnancy outcomes and using serum progesterone monitoring. We excluded interventional studies and studies involving oocyte or gamete donation. Comparisons were made between the population with EP versus non-elevated progesterone in fresh and FET cycles. Main results and the role of chance We included 52 studies (N = 53,517 women) for the systematic review. In fresh COS cycles, the incidence of EP at baseline varied from 13.3% to 30% (30% in P &amp;gt; 0.65ng/ml; 13.3% - 23.2% in P &amp;gt; 1.5ng/ml). At ovulation trigger, the incidence of EP ranged from 3.1% to 65%. (33% - 52.2% in P &amp;gt; 0.9ng/ml; 20% - 65% in P &amp;gt; 1.0ng/ml; 13.9% - 31.2% in P &amp;gt; 1.1ng/ml; 17.2% - 54.7% in P &amp;gt; 1.2ng/ml; 21.5% - 32.7% in P &amp;gt; 1.3ng/ml; 4.6% - 44.2% in P &amp;gt; 1.5ng/ml; 7% - 20.1% in P &amp;gt; 1.7ng/ml; 11.9% in P &amp;gt; 1.9ng/ml and 3.1% - 33.6% in P &amp;gt; 2.0ng/ml). The incidence of EP at egg collection ranged from 27.3% to 55.4%. (55.4% in P &amp;gt; 2.0ng/ml; 39.4% in P &amp;gt; 11.7ng/ml and 27.3% in P &amp;gt; 12ng/ml). In frozen cycles, the incidence of elevated progesterone was 68.7% at ovulation trigger in modified natural cycle FET (NC-FET). The incidence of EP before ovulation in NC-FET was 24.4% (P &amp;gt; 1.0ng/ml) and 26.4% (P &amp;gt; 1.57ng/ml). Limitations, reasons for caution Observational studies were included in this systematic review with wide variation of progesterone thresholds and timing that increases the clinical heterogeneity. The incidence of EP varies widely among the included studies. The immunoassays used for progesterone measurement were not standardised with questionable accuracy at low levels. Wider implications of the findings The incidence of EP varies significantly amongst the studies. We observed similar wide variation of EP incidence at low and high progesterone threshold level. The accuracy of immunoassays on progesterone concentrations &amp;lt;2.5ng/ml has been questioned and the non-standardized timing of progesterone measurement challenges the reliability of the measured progesterone result. Trial registration number not applicable

A prospective comparison of WALANT technique and general anesthesia in forefoot surgery

IntroductionWide Awake Local Anesthesia No Tourniquet (WALANT) technique has been widely used in hand surgery, but there are few prospective data on its use in forefoot surgery. HypothesisThe WALANT technique reduces pain compared to general anesthesia for bone surgery on the first ray of forefoot. MethodsThis was a prospective, longitudinal, comparative, non-randomized cohort study in adult patients undergoing bone surgery on the first ray of forefoot. The primary objective was the level of pain (0–10 visual analogic scale) 4 h after the procedure with WALANT technique versus general anesthesia supplemented by ropivacaine infiltration. ResultsA total 37 patients were analyzed in the WALANT group and 24 in the general anesthesia group (women, 90.2%; mean age, 51.3 years; hallux valgus, 85.2%; first metatarsal osteotomy, 80.3%). After generalized linear regression adjusted on a priori defined factors, there was no statistically difference for pain ≤3 at 4 h in WALANT vs. general anesthesia (odds-ratio 1.66; 95% CI, 0.17–20.49; p = 0.2548). At 24 h, pain level was also comparable in the two groups. Time spent in operating room was significantly shorter with WALANT (40.8 vs. 49.7 min; p = 0.0001). Mean length of stay in the recovery room was also significantly shorter with WALANT (4.4 vs. 75.6 min; p < 0.0001). Anxiety before/after surgery, uptake of analgesic/anti-inflammatory drugs and quality of life were comparable in the two anesthesia groups. ConclusionPostoperative pain with WALANT technique or general anesthesia was comparable. Time spent in the operating room and in recovery room was significantly shorter with WALANT technique. Level of evidenceIII; prospective non-randomized comparative study.

Management of impacted fetal head at cesarean birth: A systematic review and meta-analysis.

Despite increasing incidence of impacted fetal head at cesarean birth and associated injury, it is unclear which techniques are most effective for prevention and management. A high quality evidence review in accordance with international reporting standards is currently lacking. To address this gap, we aimed to identify, assess, and synthesize studies comparing techniques to prevent or manage impacted fetal head at cesarean birth prior to or at full cervical dilatation. We searched MEDLINE, Emcare, Embase and Cochrane databases up to 1 January 2023 (PROSPERO: CRD420212750016). Included were randomized controlled trials (any size) and non-randomized comparative studies (n ≥ 30 in each arm) comparing techniques or adjunctive measures to prevent or manage impacted fetal head at cesarean birth. Following screening and data extraction, we assessed risk of bias for individual studies using RoB2 and ROBINS-I, and certainty of evidence using GRADE. We synthesized data using meta-analysis where appropriate, including sensitivity analyses excluding data published in potential predatory journals or at risk of retraction. We identified 24 eligible studies (11 randomized and 13 non-randomized) including 3558 women, that compared vaginal disimpaction, reverse breech extraction, the Patwardhan method and/or the Fetal Pillow®. GRADE certainty of evidence was low or very low for all 96 outcomes across seven reported comparisons. Pooled analysis mostly showed no or equivocal differences in outcomes across comparisons of techniques. Although some maternal outcomes suggested differences between techniques (e.g., risk ratio of 3.41 [95% CI: 2.50-4.66] for uterine incision extension with vaginal disimpaction vs. reverse breech extraction), these were based on unreliable pooled estimates given very low GRADE certainty and, in some cases, additional risk of bias introduced by data published in potential predatory journals or at risk of retraction. The current weaknesses in the evidence base mean that no firm recommendations can be made about the superiority of any one impacted fetal head technique over another, indicating that high quality training is needed across the range of techniques. Future studies to improve the evidence base are urgently required, using a standard definition of impacted fetal head, agreed maternal and neonatal outcome sets for impacted fetal head, and internationally recommended reporting standards.

Hysterectomy Techniques and Outcomes for Benign Large Uteri: A Systematic Review.

To identify the optimal hysterectomy approach for large uteri in gynecologic surgery for benign indications from a perioperative morbidity standpoint. PubMed and Embase databases were searched from inception through September 19, 2022. Meta-analyses were conducted as feasible. This review included studies that compared routes of hysterectomy with or without bilateral salpingo-oophorectomy for large uteri (12 weeks or more or 250 g or more) and excluded studies with any concurrent surgery for pelvic organ prolapse, incontinence, gynecologic malignancy, or any obstetric indication for hysterectomy. The review included 25 studies comprising nine randomized trials, two prospective, and 14 retrospective nonrandomized comparative studies. Studies were at high risk of bias. There was lower operative time for total vaginal hysterectomy compared with laparoscopically assisted vaginal hysterectomy (LAVH) (mean difference 39 minutes, 95% CI, 18-60) and total vaginal hysterectomy compared with total laparoscopic hysterectomy (mean difference 50 minutes, 95% CI, 29-70). Total laparoscopic hysterectomy was associated with much greater risk of ureteral injury compared with total vaginal hysterectomy (odds ratio 7.54, 95% CI, 2.52-22.58). There were no significant differences in bowel injury rates between groups. There were no differences in length of stay among the laparoscopic approaches. For LAVH compared with total vaginal hysterectomy, randomized controlled trials favored total vaginal hysterectomy for length of stay. When rates of blood transfusion were compared between these abdominal hysterectomy and robotic-assisted total hysterectomy routes, abdominal hysterectomy was associated with a sixfold greater risk of transfusion than robotic-assisted total hysterectomy (6.31, 95% CI, 1.07-37.32). Similarly, single studies comparing robotic-assisted total hysterectomy with LAVH, total laparoscopic hysterectomy, or total vaginal hysterectomy all favored robotic-assisted total hysterectomy for reduced blood loss. Minimally invasive routes are safe and effective and have few complications. Minimally invasive approach (vaginal, laparoscopic, or robotic) results in lower blood loss and shorter length of stay, whereas the abdominal route has a shorter operative time. PROSPERO, CRD42021233300.

Systematic Review and Meta-Analysis Provide no Guidance on Management of Asymptomatic Bacteriuria within the First Year after Kidney Transplantation.

(1) Background: Urinary tract infections (UTIs) are among the most frequent complications in kidney transplant (KT) recipients. Asymptomatic bacteriuria (ASB) may be a risk factor for UTIs and graft rejection. We aimed to evaluate available evidence regarding the benefit of screening and treatment of ASB within the first year after KT. (2) Evidence acquisition: A systematic literature search was conducted in MEDLINE, the Cochrane Library CENTRAL and Embase. Inclusion criteria were manuscripts in English addressing the management of ASB after KT. The PICO questions concerned Patients (adults receiving a KT), Intervention (screening, diagnosis and treatment of ASB), Control (screening and no antibiotic treatment) and Outcome (UTIs, sepsis, kidney failure and death). (3) Evidence synthesis: The systematic review identified 151 studies, and 16 full-text articles were evaluated. Seven were excluded because they did not evaluate the effect of treatment of ASB. There was no evidence for a higher incidence of lower UTIs, acute pyelonephritis, graft loss, or mortality in patients not treated with antibiotics for ASB. Analysis of comparative non-randomized and observational studies did not provide supplementary evidence to guide clinical recommendations. We believe this lack of evidence is due to confounding risk factors that are not being considered in the stratification of study patients.

Comparative Analysis of External and Internal Radiotherapy- Dependent Plans in Patients with Gynecological Cancer.

Radiotherapy plays a key role in the treatment of gynecological cancer. Modern radiotherapy techniques with external beams (e-RT) are applied in a broad spectrum of gynecological cancer cases. However, high radiation doses, affecting normal tissue adjacent to cancer, represent the main disadvantage of e-RT regimens. For this reason, brachytherapy (BT), an internal beam-based technique (i-RT), is suggested following e-RT. Our purpose was to compare e-RT plans using volumetric-modulated arc therapy (VMAT) with those using 3D conformal techniques (3D-CRT) and compare BT plans guided by 3D or 2D imaging based on the potential corresponding toxicity levels. In this preliminary, non-randomized comparative retrospective study, 15 females suffering gynecological cancer were enrolled. Modern e-RT and i-RT (BT) techniques were applied. Concerning e-RT, D95/D99/rectum 2cc/bladder 2cc and small intestine 2cc were measured and compared; in i-RT, rectum 2cc/bladder 2cc were measured and compared. The median dose to the planning target volume in VMAT was 97.4 Gy compared with 92.9 Gy in 3D-CRT. Τhe rectum received almost 5 Gy less in VMAT compared to 3D-CRT (median of 43.5 Gy vs. 48.6 Gy; p=0.001). In the bladder, dose differences were minimal, while the small intestine received 47.6 Gy in VMAT (p=0.001). Regarding 3D-BT, the rectum received 63.1 Gy compared with 49.9 Gy (p=0.009) in 2D-BT. Concerning the bladder, mean 2D-BT and 3D-BT doses were 71.9 and 65 Gy, respectively, differing non-significantly. VMAT was found to be superior to 3D-CRT, especially in dose distribution, volume coverage and protection of critical organs. Similarly, 3D-BT should be preferred over 2D-BT due to critical advantages.

Measuring Quality of Life in Deprescribing Trials: A Scoping Review.

Quality of life (QoL) is an important outcome to capture in clinical trials evaluating deprescribing interventions. We aimed to conduct a scoping review to examine how QoL has been measured in deprescribing trials among older people and identify potentially relevant QoL scales, to better inform QoL measurement in future deprescribing trials. We searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Trials, Google Scholar, Epistemonikos, ClinicalTrials.gov, and reference lists of eligible studies (from inception to October 2023). We included randomized and non-randomized comparative studies with a control group that evaluated deprescribing and polypharmacy reduction interventions in people ≥ 65 years of age and measured QoL as an outcome. We also included studies describing the development and validation of QoL scales related to deprescribing, polypharmacy, or medication burden in adults ≥ 18 years of age. Two independent reviewers screened titles and abstracts, then full texts. Two independent reviewers extracted data from 25% of eligible studies in order to verify agreement, then a single reviewer extracted data from the remaining studies, which a second reviewer cross-checked. We critically appraised scales based on the COSMIN checklist. We retrieved 7290 articles, of which 52 were eligible for inclusion, including 44 deprescribing trials and eight scale development studies. From these studies, we found 21 scales that have been used in the context of deprescribing/polypharmacy (12 generic scales used in clinical trials and nine medication-specific scales). Variations of the generic EQ-5D were the most used scales. The measurement properties of scales for capturing changes in QoL from deprescribing were uncertain. Medication-specific QoL scales have not been employed in deprescribing clinical trials and thus, their performance in this context is also not clear. Several existing QoL scales have been applied to the context of deprescribing/polypharmacy clinical trials, and new scales specific to the problem have been proposed. If deprescribing does impact QoL, our findings suggest it is uncertain whether existing QoL scales can practically and reliably capture such a change or whether any scale is best. However, this review compares various aspects of the scales that researchers and clinicians can consider in decisions about measuring QoL in deprescribing trials, and in planning future research. Open Science Framework: osf.io/aez6w.

Additive toxicity arising from combined use of immune checkpoint inhibitors and tyrosine kinase inhibitors in patients with renal or endometrial carcinoma: Protocol for a rapid systematic review

The combined use of immune checkpoint inhibitors and tyrosine kinase inhibitors (ICI/TKI) is an effective treatment strategy for some cancers. A better understanding of the potential additive toxicity for ICI/TKI combinations is needed to inform patient and provider treatment decisions. We aim to evaluate the safety of ICI/TKI combinations for individuals with renal cell or endometrial carcinoma. This rapid systematic review (SR) protocol follows PRISMA guidelines. A systematic search will be designed, peer reviewed and executed by experienced information specialists (Cochrane Central, MEDLINE, Embase) to identify published SRs and primary studies published since the most recent SR search. Randomized, quasi- or non-randomized controlled trials and comparative cohort studies are eligible if they compare ICI/TKI combinations to monotherapy or standard of care in participants with renal cell or endometrial carcinoma. The primary outcome is grade ≥ 3 treatment-related adverse-effects. Studies will be screened, selected, extracted and assessed for risk of bias by a single reviewer and checked completely by a second. Where feasible and appropriate, we will pool studies separately by design and indication using meta-analysis and test robustness of effects using prespecified subgroup and sensitivity analyses. Results will be summarized descriptively and presented in tables and figures. (PROSPERO ID: CRD42023416388).•This will be a comprehensive systematic review of the additive toxicity arising from the combined use of ICI/TKIs in patients with renal-cell or endometrial carcinoma.•We will consider treatment-related, treatment-emergent adverse events (Grade 3 or higher).•Identified safety profile may be used to inform patient or provider treatment decisions.

«Проблемные ситуации»: апробация в качестве судебно-психиатрического метода исследования при изменении гражданско-правового статуса

&lt;p style="text-align: justify;"&gt;As part of solving the task of developing methods to improve the quality and evidence of forensic psychiatric decisions, in a comparative non-randomized study the &amp;ldquo;Problem Situations&amp;rdquo; methodology was tested as a method of forensic psychiatric assessment in civil cases on applications for change civil legal status. The sample consisted of 67 subjects who underwent inpatient forensic psychiatric examination in connection with the decision on the issue of changing their civil status in 2021&amp;mdash;2022. A conclusion corresponding to legal capacity was given in relation to 12 people; diminished legal capacity - 24 people; incapacity &amp;mdash; 31 people. Pairwise group comparisons using Pearson&amp;rsquo;s goodness-of-fit test (Chi-square) and biclustering procedures confirmed the predictive validity of the method.&lt;/p&gt;

Comparison of laser ablation and Karidakis surgery for treating epithelial coccygeal passages

BACKGROUND: Laser ablation is a technique which was originally used to treat various cystic and fistulous structures. Due to promising results, surgeons began to use diode lasers to treat pilonidal cysts. The authors developed their own technique of ultrasonic-guided laser ablation in patients with the discussed pathology. AIM: To compare outcomes after laser ablation and Karidakis surgery for treating pilonidal cysts. METHODS: A prospective non-randomized comparative study was performed. Outcomes of surgical interventions were analyzed in 71 patient with pilonidal disease: 24 patients were operated with laser obliteration technique and 47 — with Karidakis technique. The researchers compared: time of wound healing and number of recurrences, complications, length of hospital stay and duration of postoperative pain. RESULTS: Mean operative time in the laser group was 26.45±5.41 min (20–35 min), while in the Karidakis group — 58.63±7.42 min (50–75 min). In the laser group, primary healing was registered in 23 out of 24 patients (95.8%) with an overall complication rate 20.83%. In each group, there were registered two cases with relapses after discharge. The obtained clinical results, in general, were comparable to those in the world literature. However, the quality of life of patients after laser treatment was significantly better than after traditional surgical intervention which is confirmed by less hospital stay up to 5–7 bed-days; by less surgical time, in average, 25 minutes; faster recovery — within one week after surgery; faster return to everyday life, as well as less pain syndrome in the postoperative period. CONCLUSION: Laser ablation of the coccygeal tract is comparable to Karidakis surgery in terms of wound healing and recurrences, but it gives better results in terms of surgical time, hospital stay and postoperative pain.

Comparing Outcomes of Tube Versus Trabeculectomy Among Patients With Angle-closure Glaucoma

PurposeCompare outcomes of tube shunt surgery (Tube) and trabeculectomy with Mitomycin C (Trab-MMC) in patients with angle-closure glaucoma (ACG). DesignRetrospective, nonrandomized comparative study. SubjectsA total of 80 eyes from 80 patients with ACG who underwent either Tube (N = 50) or Trab-MMC (N = 30) between January 2015 and January 2022 at Massachusetts Eye and Ear. MethodsReviewed and analyzed 390 visits from patient charts. Main outcome measuresKaplan-Meier (KM) success rates, Intraocular pressure (IOP), medication burden, best-corrected visual acuity (BCVA), adjusted hazard ratios (HRs), and complications. ResultsBaseline demographics were similar between both groups, except for a higher proportion of patients with pseudophakia and prior incisional ocular surgery in the Tube group. The Trab-MMC procedure had significantly higher Kaplan-Meier complete success (CS) rates than the Tube procedure, but similar qualified success (QS) rates. Under QS, the cumulative probability of survival was 87% in the Tube group and 83% in the Trab-MMC group at year 1 (P=0.77), and 75% in the Tube group and 58% in the Trab-MMC group at year 2 (P=0.14). Under CS, the cumulative probability of survival was 13% in the Tube group and 59% in the Trab-MMC group at year 1 (P<0.001), and 11% in the Tube group and 41% in the Trab-MMC group at year 2 (P<0.001). Both Tube and Trab-MMC procedures resulted in significant patterns of IOP and medication reduction from baseline up to 2 years with mean IOP reduced to 12.6 ± 5.9 mmHg on 2.8 ± 1.4 medications after Tube, and 12.1 ± 6.6 mmHg on 2.4 ± 1.7 medications after Trab-MMC. Patients who underwent Trab-MMC required less IOP-lowering medications at every follow-up visit up to year 1, but a similar number at year 2. No significant differences were found in IOP reduction, BCVA, or complication rates between groups.” ConclusionWe demonstrate that Trab-MMC confers similar IOP reduction and QS rates to Tube placement in ACG patients. Trab-MMC, however, demonstrated greater medication burden reduction up to 1 year, and more favorable CS rates up to 2 years, while still maintaining similar complication rates to Tube.

Trends in outcomes used to measure the effectiveness of UK-based support interventions and services targeted at adults with experience of domestic and sexual violence and abuse: a scoping review

ObjectivesIn the UK, a range of support services and interventions are available to people who have experienced or perpetrated domestic and sexual violence and abuse (DSVA). However, it is currently...

Local Production of World Health Organization Recommended Hand Rub Formulation and Comparison of its Efficacy with a Commercially Available Alcohol-Based Hand Rub

Objective: To produce a World Health Organization (WHO)-recommended hand rub formulation locally and compare its efficacy with a commercially available Alcohol-based Hand Rub (ABHR) - Sterillium. Methods: A non-randomized comparative study was conducted. Sixty healthcare workers were divided into two groups - Group A (WHO-recommended hand rub) and Group B (Sterillium). WHO-recommended hand rub was prepared according to the specified formula. Each participant from study Group A received three ml of WHO-recommended hand rub formulation, and each study Group B participant received three ml of Sterillium. Bacterial samples of each participant (from both hands) were collected before and 0 after using an ABHR solution. Samples were inoculated on the nutrient agar plates and incubated at 37 C for 24 hours. The total number of bacterial colonies grown on plates inoculated before and after ABHR use was counted and identified by standard microbiology techniques and compared between the two groups. The WHO-recommended hand rub and Sterillium were compared and analyzed using differences in proportion. Results: The overall reduction in bacterial growth was comparable for both the hand rubs, with an average load reduction of log 1.5607 for locally produced hand rub solution and an average load reduction of log 1.609 in the case of Sterillium. Conclusion: Both of the handrubs are comparable in efficacy and are effective against all the bacteria isolated from the palms of HCWs (Coagulase Negative Staphylococcus (CoNS), Micrococcus spp., Acinetobacter spp., Bacillus spp., Pseudomonas spp., and Citrobacter), including Methicillin-Sensitive Staphylococcus aureus