Comparative Controlled Trial Research Articles

DIGITAL DETECTION OF DEMENTIA (D CUBED) TRIALS

Abstract At Indiana University, we leveraged electronic health record (EHR) data and Machine Learning algorithms to develop a Passive Digital Marker (PDM) for dementia detection with 80% accuracy. At the University of Miami, we developed the Quick Dementia Rating Scale (QDRS) as a 2-3 minute patient-reported outcome tool with 85% accuracy for dementia diagnosis. Two pragmatic cluster-randomized controlled comparative effectiveness trials randomized primary care clinics to Usual care, PDM alone, and both the PDM and the QDRS. Trials recruited diverse rural, suburban and urban primary care practices located in central Indiana and south Florida. The positive results are communicated via the EHR only to clinicians within the PDM and PDM + QDRS clinics during an ambulatory primary care visit. The primary outcome measure is the annual rate of new documented dementia diagnosis. In the first year, the Indiana trial enrolled 5960 older patients with a mean age of 71.9 years and SD of 6.50, 61% were female and 51% were African American. In the clinics that were randomized to PDM + QDRS, there were 827 patients who completed at least one question on the QDRS. The Indiana trial used a non-interruptive Best Practice Alert (BPA) for the first year of operation. For the second year of operation, the trial coupled the BPA with an InBasket message to primary care physicians to overcome the shortcoming of the Non-interruptive nature of the BPA. We have created an IT implementation manual to deploy the PDM with minimum expertise.

A meta-epidemiological analysis of post-hoc comparisons and primary endpoint interpretability among randomized noncomparative trials in clinical medicine

Randomized noncomparative trials (RNCTs) promise reduced accrual requirements vs randomized controlled comparative trials because RNCTs do not enroll a control group and instead compare outcomes to historical controls or prespecified estimates. We hypothesized that RNCTs often suffer from two methodological concerns: (1) lack of interpretability due to group-specific inferences in nonrandomly selected samples and (2) misinterpretation due to unlicensed between-group comparisons lacking prespecification. The purpose of this study was to characterize RNCTs and the incidence of these two methodological concerns. We queried PubMed and Web of Science on September 14, 2023, to conduct a meta-epidemiological analysis of published RNCTs in any field of medicine. Trial characteristics and the incidence of methodological concerns were manually recorded. We identified 70 RNCTs published from 2002 to 2023. RNCTs have been increasingly published over time (slope=0.28, 95% CI 0.17-0.39, P<.001). Sixty trials (60/70, 86%) had a lack of interpretability for the primary endpoint due to group-specific inferences. Unlicensed between-group comparisons were present in 36 trials (36/70, 51%), including in the primary conclusion of 31 trials (31/70, 44%), and were accompanied by significance testing in 20 trials (20/70, 29%). Only five (5/70, 7%) trials were found to have neither of these flaws. Although RNCTs are increasingly published over time, the primary analysis of nearly all published RNCTs in the medical literature was unsupported by their fundamental underlying methodological assumptions. RNCTs promise group-specific inference, which they are unable to deliver, and undermine the primary advantage of randomization, which is comparative inference. The ongoing use of the RNCT design in lieu of a traditional randomized controlled comparative trial should therefore be reconsidered.

Valgus Osteotomy versus Arthroplasty for Ununited Femoral Neck Fractures: A Systematic Review

Abstract Background Fractures of the neck of femur in young adults tend, unlike their counterparts in older people, to be a relatively higher energy injury and require timely and meticulous diagnosis and management. Anatomical reduction and stable internal fixation are essentials for achieving the goals of treatment in this young population allowing preservation of the femoral head while minimizing rates of non-union and osteonecrosis. Aim of the Work The aim of this systematic review is to collate evidence from comparative studies to look for significant differences between valgas osteotomy &amp;arthroplasty in non united femoral neck fractures in &amp;lt; 50yr old patients. Patients and Methods Only studies with Randomized controlled trials and comparative non controlled trials had been included. The study included Valgas osteotomy &amp; arthroplasty for ununited femoral neck fractures. Application of inclusion and exclusion criteria to study Abstracts yielded 11articles. The full-text articles for these 40 studies were then reviewed and subjected to our inclusion criteria. A total of 11 articles were eligible for final systematic review. Results There was improvement in Harris hip score in all included studies ranged from 79.8 to 95. In comparison between two groups, groups with THA had significantly higher Harris hip score than osteotomy score. In this review reoperation and infection were common among osteotomy group than total hip arthroplasty group. Conclusion Although non-union problems following femoral neck fractures are common, the primary objective is to preserve the hip, by seeking alternative methods, specifically in young patients, and considering that the femoral neck can usually remain viable. Therefore, alternatives such as valgus osteotomy, which enables union by solving mechanical issues and allows patients to live with their own bones, have long been in use and successful Valgus intertrochanteric osteotomy is the treatment of choice for active patients aged less than 50 years with a nonunion of a femoral neck fracture. This technique requires precise preoperative planning and intraoperative skill. Patients should be warned of the risk of avascular necrosis, as well as the difficulty in performing revision arthroplasty in this setting.

Program ACTIVE II: 6- and 12-month outcomes of a treatment approach for major depressive disorder in adults with type 2 diabetes

To evaluate the long-term effects of behavioral treatments on glycemic and psychological outcomes for patients with major depressive disorder (MDD) and type 2 diabetes (T2D). Program ACTIVE II was a multicenter randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), exercise (EXER), combination treatment (CBT+EXER) and usual care (UC) for adults with MDD and T2D. Primary outcomes: change in A1c and depressive symptoms at 6- (N=87) and 12-months (N=75) from baseline. In those with a baseline A1c ≥7.0%, CBT+EXER showed lasting A1c benefit at 6- (-1.2%; SE: 0.6; p=0.032) and 12-months (-1.4%; SE: 0.6; p=0.025) compared to UC. All groups had clinically significant improvements in depressive symptoms. At 6months, CBT+EXER had significant improvements in diabetes-related distress regimen burden (p=0.005); and social support (CIRS, p=0.043) compared to UC. The Program ACTIVE II CBT+EXER intervention demonstrated a sustained improvement in A1c for a subgroup of study participants with a baseline A1c ≥7.0%. However, this finding should be considered preliminary because of small sample size. All 3 behavioral intervention groups demonstrated improvements in psychosocial outcomes one-year post-intervention. These findings point to the enduring benefits of community-based interventions to extend the availability of depression treatment for T2D patients.

Comparing an Intermittent Fasting Intervention With a Continuous Energy Restriction Intervention On Weight Loss in Community-Based Black Adults

Introduction: Compared to other racial/ethnic groups, Blacks have the highest rates of obesity, a well-established risk factor for some cancers. Continuous caloric energy restriction (CER) interventions consist of small reductions in daily caloric intake and are recommended by government agencies to treat obesity. However, these interventions are difficult to adhere to and cause less weight loss in Blacks compared to Whites. Intermittent fasting (IF), which can consist of eating 25% of one's daily calorie intake per day on some days and ad libitum intake on other days, causes the same amount of weight loss as CER interventions. IF may be easier for participants to adhere to and may lower cancer risk and prognosis to a greater extent than can be attributed to weight loss alone. However, most IF studies have been conducted with White participants, and have provided participants with standardized meals and/or nutrition counseling not readily available in real-world situations. Thus, the purpose of our study is to test the effect of IF interventions in diverse groups outside of controlled settings. Methods: We are comparing a 6-month CER intervention with a 6-month IF intervention on weight loss in Black adults using a blinded randomized controlled comparative effectiveness trial. Trained community health workers are delivering the interventions. Six churches (anticipated n = 60) were randomized to either intervention. Staff blinded to treatment condition are collecting anthropometric, 3-day dietary food recall, and survey data at baseline and 6-month follow-up. Results: To date, four churches (n = 29) have completed baseline and follow-up assessments. Most participants were female (82.6%) with a mean age of 57.9 years. There were significant within group differences, with both IF and CER participants losing 3.2% (4.4) and 2.8% (4.5), respectively, of their body weight from baseline to 6-month follow-up. Conclusion: This is the first study to test an IF intervention designed for community-based Black adults in a 'real-world' setting. If proven effective, this IF intervention has the potential to serve as an alternative to CER interventions for weight loss and cancer risk reduction in minority populations.

Effect of growth hormone cotreatment in sub-fertile women ≥ 40 years: A Meta-analysis.

Treatment of sub-fertile women aged ≥ 40 years old (AMA) is challenging. Co-treatment with growth hormone (GH) is suggested to improve reproductive outcomes in poor responders. However, few studies, and with conflicting results, focused on women with AMA. A systematic review and meta-analysis of randomized controlled trials (RCTs) and comparative retrospective trials (CRTs) of GH cotreatment in AMA women undergoing in vitro fertilization or intracytoplasmic injection treatment using their autologous oocytes was performed. The search included studies published in English up to the end of 2021. The primary outcome was the clinical pregnancy rate per embryo transfer. Secondary outcomes were the number of mature and retrieved oocytes and the rate of live birth. 406 studies were found. The final analysis included three RCTs and four CRTs with 481 patients who used GH and 400 patients who did not. Clinical pregnancy and live birth rates were significantly higher in the GH cotreatment group compared to the placebo as well as the group without GH co-treatment, (OR 2.2; 95% CI 1.34 - 3.61 and OR 4.12; 95% CI 1.82 - 9.32, respectively). Intriguingly, the subgroup analysis showed that poor-responder patients did not benefit from co-treatment with GH. There were no statistically significant differences in the number of mature or retrieved oocytes. GH cotreatment in a subgroup of women with AMA improves clinical pregnancy and live birth per fresh embryo transfer. However, this conclusion must be taken with caution and further research is needed. The review is registered in PROSPERO database (CRD42021252618). www.crd.york.ac.uk/prospero/.

Minimally Invasive versus Open Repair for the Treatment of Acute Achilles Tendon Rupture in Adults: A Prospective Randomized Controlled Study

Abstract BACKGROUND The aim of this study is to compare open repair and minimally invasive repair in acute Achilles tendon rupture in adults regarding operative techniques, functional outcome and complications. DESIGN A prospective randomized controlled comparative trial. METHODS 40 consecutive cases with acute complete Achilles tendon rupture were divided randomly in 2 equal groups (20 treated by open Krackow repair and 20 treated by minimally invasive repair with the PARS device), average age 41 years, follow up time was average of 7 months. Patients were assessed clinically and functional scoring system of postoperative American Orthopaedic Foot &amp; Ankle Society ankle-hindfoot score (AOFAS) was used postoperatively. RESULTS Our results found that there were no significant differences between both groups in rates of postoperative complications (MIS group 10%, open repair group 15; P = 0.134). PARS group had greater postoperative AOFAS score, early rehabilitation, better cosmetic appearance and smaller scar length than open Krackow repair of acute Achilles tendon rupture. CONCLUSIONS We have found out that minimally invasive techniques such as the PARS are clinically and biomechanically suitable alternatives to open repair based on both clinical outcomes and repair strength.

Effect of capsular tension ring on optical and multifunctional lens position outcomes: a systematic review and a meta-analysis.

To evaluate the effect of capsular tension rings with multifunctional lens position and optical outcomes. We defined multifunctional lens as more than improving vision, but also to restore visual quality. PubMed, EMBASE, Cochrane Library and Scopus were searched for English-language articles published up to November 11, 2020. Randomized controlled trials and comparative prospective clinical trials were selected. Data extraction was completed by independent pairs of reviewers. The risk of bias was evaluated using the Cochrane Collaboration's risk-of-bias tool for RCTs and select items from the Newcastle-Ottawa Scale for comparative prospective clinical trials. A total of 5 randomized controlled trials and 6 prospective comparative clinical trials were included. One thousand nine hundred and ninety-nine eyes of implantation intraocular lens were evaluated. Capsular tension ring was helpful in un-corrected distance visual acuity (SMD: 0.54, 95% CI = 0.15 to 0.94, p = 0.829) in 1st month. Contrary to 1st month, no show positive effect in 3rd month un-corrected distance visual acuity (SMD: - 0.30, 95% CI = - 0.70 to - 0.10, p = 0.311), corrected distance visual acuity (SMD: 0.02, 95% CI = - 0.78 to 0.81, p < 0.001), sphere (SMD: 0.44, 95% CI = - 0.43 to 1.31, p < 0.001), cylinder (SMD: - 0.12, 95% CI = - 0.36 to 0.13, p = 0.262), and spherical equivalent (SMD: 0.41, 95% CI = 0.13 to 0.69, p = 0.084). Our study also revealed low correlation between capsular tension ring and postoperative optical outcome with un-corrected distance visual acuity (SMD: 0.43, 95% CI = - 0.69 to 1.56, p = 0.001), corrected distance visual acuity (SMD: - 0.11, 95%CI = - 0.43 to 0.20, p = 0.56), sphere (SMD: - 0.26, 95%CI = - 1.18 to 0.66, p = 0.005), cylinder (SMD: 0.10, 95% CI = - 0.39 to 0.59, p = 0.075), spherical equivalent (SMD: 0.22, 95%CI = - 0.10 to 0.54, p = 0.849) in 6th month. The position of intraocular lens co-implantation with capsular tension ring has no significant difference in 1st week with lens decentration (SMD: - 0.34, 95% CI = - 1.19 to 0.51, p = 0.038) and tilt (SMD: - 1.00, 95% CI = - 2.19 to 0.19, p = 0.007), but capsular tension ring is helpful to prevent lens tilt in 1st month (SMD: - 0.67, 95%CI = - 1.08 to 0.27, p = 0.323). In 3rd month, there was no significant difference between two groups in lens rotation (SMD: - 0.51, 95%CI = - 1.71 to 0.69, p < 0.001). The correlation is low between capsular tension ring and postoperative optical outcomes and lens position, based on small numbers of studies in a short range of follow-up.

Efficacy and safety of pharmacological, physical, and psychological interventions for the management of chronic pain in children: a WHO systematic review and meta-analysis.

Chronic pain in childhood is an international public health problem. We conducted a systematic review and meta-analysis to provide a summary of the published evidence of pharmacological, physical, and psychological therapies for children with chronic pain conditions. We searched CENTRAL, MEDLINE, EMBASE, and PsycINFO from inception to April 2020; clinical trial registries; and other sources for randomised controlled trials or comparative observational trials. We extracted critical outcomes of pain intensity, quality of life, physical functioning, role functioning, emotional functioning, sleep, and adverse events. We assessed studies for risk of bias and certainty of the evidence using GRADE. We included 34 pharmacological (4091 participants), 25 physical therapy (1470 participants), and 63 psychological trials (5025 participants). Participants reported a range of chronic pain conditions. Most studies were assessed to have unclear or high risk of bias across multiple domains. Pharmacological, physical, and psychological therapies showed some benefit for reducing pain, posttreatment, but only physical and psychological therapies improved physical functioning. We found no benefit of any treatment modality for health-related quality of life, role functioning, emotional functioning, or sleep. Adverse events were poorly reported, particularly for psychological and physical interventions. The largest evidence base for the management of chronic pain in children supports the use of psychological therapies, followed by pharmacological and physical therapies. However, we rated most outcomes as low or very low certainty, meaning further evidence is likely to change our confidence in the estimates of effects. This protocol was registered on PROSPERO (CRD42020172451).

Evaluation of Treatment of Tinea Corporis and Tinea Cruris with Oral Terbinafine Using Direct Microscopic Examination with Special Stains

Terbinafine is a fungicidal allylamine drug and was considered a drug of choice to treat dermatophyteinfection. However recently there wasan increase in the incidence of clinical failure and relapses withterbinafine.Aims and Objectives: This study was undertaken to assess the effectiveness and safety of oral terbinafine250 mg given in patients suffering from tinea cruris and tinea corporis for 6 weeks.Materials and Method: In a prospective, open-label randomized controlled comparative trial 40 patientssuffering from tinea cruris and tinea corporis were recruited. Only patients with tinea cruris and tineacorporis, confirmed through positive microscopy before the start of treatment were eligible for inclusionin the trial. The patients were distributed into two groups and randomly allocated into group A and groupB of 20 patients each. Both groups received the same treatment i.e., oral Terbinafine 250mg once daily for6 weeks. Patients of both groups were followed up at weeks 2, 4, 6 during treatment and at the end of 8weeks. Mycological control test for group A and group B patients were done by KOH mount at baselineand each visit. Patients of group B underwent mycological control testing in the form of KOH mount withthe concurrent use of DMSO and CSB at baseline and each visit. By the end of treatment clinical andmycological cure were evaluated.Results: In group A (mycological testing with only KOH was done), fungal elements were detected in100%, 40%, 20%, 0% and 0% of baseline patients, 2 weeks, 4 weeks, 6 weeks and 8 weeks respectively.In group B (mycological testing with KOH and DMSO+CSB was done), fungal elements were detected in100%, 75%, 50%, 10% and 15% of baseline patients, 2 weeks, 4 weeks, 6 weeks and 8 weeks respectively.Even after 2 weeks of completion of oral terbinafine 250 mg for 6 weeks,the clinical cure was not seen in40% and 35% patients in groupA and group B.Conclusion: Although mycological cure was achieved in more than 90% of patients in group A and group Bafter 8 weeks clinical cure was achieved in only 60% and 65 % patients in group A and group B respectively.Implying that we need to continue oral terbinafine for a longer period to achieve mycological as well as aclinical cure.

Modified Wilson’s versus scarf osteotomy for treatment of hallux valgus: a prospective clinical randomized controlled study

Background A prospective randomized controlled comparative trial formulated to compare modified Wilson’s osteotomy and scarf osteotomy in treatment of cases of hallux valgus deformity in terms of operative time, functional, radiological outcomes, and complications. Methods Forty cases with hallux valgus were divided randomly into 2 groups; 37 reached the final follow-up (18 underwent scarf and 19 underwent modified Wilson’s osteotomy), average age 37.34 years. Average follow-up period was 24.13 months. Patients were assessed clinically and radiologically, in addition to preoperative and postoperative functional scoring system of American College of Foot and Ankle Surgeons (ACFAS). Results Operative time was 64.91 min in the scarf group compared to 65.63 min in the modified Wilson’s group; x-ray evaluation showed no statistically significant difference between both groups. ACFAS score showed functional improvement in both groups but the improvement was superior in the modified Wilson group 71.17% compared to the scarf group 59.23%. Conclusions Both modified Wilson’s and scarf osteotomies showed nearly same efficacy regarding correction of deformity of the intermetatarsal angle and comparable results clinically but somewhat shorter operative time for the scarf group and personal impression of technical simplicity for the modified Wilson’s osteotomy

Immediate versus Delayed Implant placement in Diabetic Patients rehabilitated with Mandibular Overdentures – A Split mouth study

Purpose: This comparative controlled trial (CCT) evaluates the survival rate of implants placedinto fresh extraction sockets and compare it with implants placed in healed sites in type 2 diabetic,completely edentulous subjects rehabilitated with mandibular implant overdentures (MIODs) followinga delayed loading protocol and opposed with conventional complete dentures.Materials and Methods: Fourteen implants were placed in seven well-controlled diabeticsubjects as determined by Glycosylated hemoglobin (HbA1c) values before implant placement(baseline) and throughout the follow-up period. Each patient received two implants; one implant inhealed canine site and the other was immediately inserted following the extraction of an existingperiodontally hopeless canine. The implants were uncovered approximately 3 months after placementand restored with bar-retained overdenture. The patients were scheduled for regular follow-upappointments and for data collection. Kaplan-Meier analysis was used to calculate implant survivalfrom time of prosthesis placement through 24-month follow-up period.Results: No implant failed in the delayed placement group within the 2 years study period,whereas in the immediate group two implants failed in two patients following the prosthetic loadingat one-year follow-up period resulting in 71.2% implant survival rate. HbA1c levels ranging from7.4 to 8.0 percent were identified in two patients with implant failures. There was no statisticallysignificant difference in survival rate between immediate and delayed implants in type 2 Diabeticsubjects rehabilitated with MIOD s (P=0.141).Conclusions: Within the limitations of this study, insufficient evidence exists to recommendimmediate implant placement in type 2 diabetic subjects rehabilitated with MIODs.

A4214 The Rationale, Design, and Baseline Characteristics of BP-CONNECT

Objectives: Only 13.8% of 27 million hypertension patients controlled their BP in China. Although mhealth technology have been used in many health improvement context, rigorous evidence is still rarely seen. Practical and well-designed study is needed to evaluate the efficacy in patients with uncontrolled hypertension with modern mhealth technology. To determine whether an intervention that combines usual routine care, mHealth based home BP telemonitoring, patient case management with community health workers and virtual social media support improves BP control comparing with usual care plus normal BP telemonitoring at 6,12 and 18 months in patients with uncontrolled hypertension in primary care settings. Methods: The BP-CONNET study was designed as a community-based multi-center open-labeled randomized controlled comparative effectiveness trial conducted in Beijing China. Results: Between January 2017 and June 2017, BP-CONNET enrolled 601 hypertensive patients with uncontrolled BP from 19 community health centers. Three hundred and seven patients were randomized intervention group which provide mobile internet base home BP monitoring plus case management with community health worker and WeChat based virtual social media support. Two hundred and ninety-four were randomized to control group which provide usual care and normal BP telemonitoring. For the intervention group, physicians and community health workers collaborated through mobile internet based on the home BP data to provide BP case management services. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention. Conclusion: The results will provide important new evidence regarding effects of this intervention model in real world community clinic settings and primary care hypertensive population.

Program ACTIVE II—Glycemic Improvements Are Sustained over 12 Months with Combination Therapy for MDD in Adults with T2DM

Few studies have evaluated the long-term comparative effects of behavioral treatments for major depressive disorder (MDD) on glycemic and psychological outcomes. Program ACTIVE II was a multi-state randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), community-based exercise (EXER), combination treatment (CBT+EXER) or usual care (UC) for adults with MDD and type 2 diabetes (T2DM). CBT+EXER had a lasting A1c benefit at 6-months (-1.27%; SE: 0.6; p=0.04) and 12 months (-1.42%; SE: 0.6; p=0.03) compared to UC in those with baseline A1c ≥ 7.0%, after controlling for baseline covariates. At 6-month (N=74) and 12-month (N=64) follow-up assessments, all groups had high rates of MDD full remission (range: 63-93%; NS) and minimal depressive symptoms (BDI total score range: 10.7-15.6; NS). At 6 months, CBT+EXER had significant improvements in diabetes-related distress regimen burden (p=0.05); and personal support for health (p=0.05) compared to UC. EXER had improvements in negative thoughts (p=0.005), community social support (p=0.005), diabetes-specific quality of life (DQoL; p=0.04) and satisfaction with T2DM (p=0.01) compared to UC. CBT had improvements over UC in personal support for health (p=0.04) and DQoL (p=0.047). At 12 months, all 3 treatment groups reported improved support from health care providers (p=0.03 CBT, EXER and CBT+EXER) compared to UC. CBT+EXER had improved SF-12 Physical Component Scores (p=0.04) compared to UC. The Program ACTIVE II CBT+EXER intervention had a sustained benefit for A1c beyond the effect of MDD full remission. All 3 behavioral interventions sustained improvements in psychological well-being over 1 year. These findings highlight durable benefits of community-based depression interventions delivered by behavioral health and exercise professionals, which could allow expanded access to depression treatment for T2DM patients in rural and urban areas. Disclosure M. de Groot: Consultant; Self; Johnson &amp;Johnson Diabetes Institute, LLC., Eli Lilly and Company.W. Hornsby: None.C.K. Saha: None.Z. Yang: None.Y. Pillay: None.K.M. Fitzpatrick: None. K.J. Mather: Research Support; Self; Merck &amp;Co., Inc., Sanofi-Aventis, Novo Nordisk A/S, Abbott. Advisory Panel; Self; Merck &amp; Co., Inc.J.H. Shubrook: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc., Intarcia Therapeutics, Inc..

Scarf versus long chevron osteotomies for the treatment of hallux valgus: A prospective randomized controlled study

The aim of this study is to compare scarf osteotomy and long chevron osteotomy in treatment of hallux valgus deformity regarding operative time, power of correction and complications. A prospective randomized controlled comparative trial. 48 cases with hallux valgus were divided randomly in 2 groups (21 treated by scarf and 22 treated by long chevron osteotomy and 5 were missed during follow up), average age 36 years, follow up time was average of 25.9 months. Patients were assessed clinically, radiologically, and functional scoring system of American College of Foot and ankle Surgeons (ACFAS)was used both pre and postoperatively. Operative time was 69min in scarf group compared to 63min to long chevron group, radiological correction showed no statistically significant difference between both groups while functional improvement in ACFAS score was in favour of long chevron group 69.1% compared to scarf group 57.5% CONCLUSIONS: Both osteotomies possess almost identical corrective power of the IMA (intermetatarsal angle) and similar clinical outcomes with slightly shorter operative time and subjective technical simplicity for the long chevron osteotomy.

Effectiveness of educational program using printed educational material on care burden distress among staff of residential aged care facilities without medical specialists and/or registered nurses: Cluster quasi-randomization study.

Behavioral and psychological symptoms of dementia are an important source of distress for caregivers. The aim of the present study was to evaluate the effectiveness of educational intervention using printed educational material for reducing distress induced by behavioral and psychological symptoms of dementia among caregivers working at facilities without medical specialists and/or registered nurses. A cluster quasi-randomized, controlled comparative trial was carried out at 17 facilities in Japan. Our intervention was an educational program administered at baseline using printed educational material for the care staff. The primary outcome was evaluated using the Japanese version of the Neuropsychiatric Inventory Questionnaire. The secondary outcome measures were caregiver burnout evaluated using the Japanese version of the Maslach Burnout Inventory and the care dependency of residents measured using the Japanese version of the Care Dependency Scale. The total Neuropsychiatric Inventory Questionnaire score decreased significantly in the intervention group (F [1355] = 6.57, P = 0.01), and the difference between the intervention and control groups was also significant (F [1355] = 4.78, P = 0.03). There were no significant changes in the Maslach Burnout Inventory or Care Dependency Scale scores in the intervention group, while the Maslach Burnout Inventory subscale (personal accomplishment) score decreased significantly in the control group. Our intervention achieved a significant reduction of distress among caregivers working at care homes without medical specialists and/or registered nurses. The findings of this research show that educational intervention can make a valuable contribution to training programs for care staff. Geriatr Gerontol Int 2018; 18: 487-494.

Categorization and Analysis of Disaster Health Publications: An Inventory.

Disaster Medicine is a relatively new discipline. Understanding of the current status of its science is needed in order to develop a roadmap for the direction and structure of future studies that will contribute to building the science of the health aspects of disasters (HADs). The objective of this study was to examine the existing, peer-reviewed literature relevant to the HADs to determine the status of the currently available literature underlying the science of the HADs. A total of 709 consecutive, peer-reviewed articles published from 2009-2014 in two disaster-health-related medical journals, Prehospital and Disaster Medicine (PDM) and Disaster Medicine and Public Health Preparedness (DMPHP), were examined. Of these, 495 were disaster-related (PDM, 248; DMPHP, 247). Three major categories defined these disaster-related research articles: (1) Epidemiological studies comprised 50.5%; (2) Interventional, 20.3%; and (3) Syntheses, 26.9%. Interventional studies were sub-categorized into: (a) Relief Responses, 23.0%; (b) Recovery Responses, 2.0%; or (c) Risk-Reduction Interventions, 75.0%. Basically, the inventories were consistent within the two journals. Reported indicators of outcomes related to the responses were constrained to achievement indicators (numbers accomplished). Syntheses articles were sub-categorized into: (a) Literature Reviews, 17.6%; (b) Opinions, 25.2%; (c) Models, 24.4%; (d) Frameworks, 6.9%; (e) Guidelines, 13.0%; (f) Tools, 3.0%; (g) Protocols, Policies, or Criteria, 2.3%; or (h) Conference Summaries, 7.6%. Trend analyses indicated that the relative proportions of articles in each category and sub-category remained relatively constant over the five years. No randomized controlled trials (RTCs), non-randomized, comparative controlled trials (CCTs), or systematic reviews were published in these journals during the period examined. Each article also was examined qualitatively for objectives, study type, content, language, and structure. There was no common structure used for any category or sub-categories. In addition, the terminology used was inconsistent and often confusing. This categorization process should be applied to other peer-reviewed journals that publish research related to HADs. As evidenced in the current study, the evidence base for HADs is far from robust and is disorganized, making the development of scientific evidence on which to base best practices difficult. A stronger evidence base is needed to develop the science associated with the HADs. This will require a common structure and terminology to facilitate comparisons. Greater depth of reporting is needed in order to render the Epidemiological studies more useful in mitigating the negative health impacts of hazard-related events. Interventional studies must be structured and include outcomes, impacts, benefits, and costs with robust indicators. The outcomes and impacts of Risk-Reduction Interventions will require the evaluation of changes in the epidemiology documented in future events or exercises. Birnbaum ML , Adibhatla S , Dudek O , Ramsel-Miller J . Categorization and analysis of disaster health publications: an inventory. Prehosp Disaster Med. 2017;32(5):473-482 .

Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial

Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence-based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients.

Convalescence after laparoscopic inguinal hernia repair: a qualitative systematic review

Duration of convalescence after inguinal hernia repair is of major socio-economic interest and an often reported outcome measure. The primary aim was to perform a critical analysis of duration of convalescence from work and activity and secondary to identify risk factors for unexpected prolonged convalescence after laparoscopic inguinal hernia repair. A qualitative systematic review was conducted. PubMed, Embase and the Cochrane database were searched for trials reporting convalescence after laparoscopic inguinal hernia repair in the period from January 1990 to January 2016. Furthermore, snowball search was performed in reference lists of identified articles. Randomized controlled trials and prospective comparative or non-comparative trials of high quality were included. Trials with ≥100 patients, >18years of age and manuscripts in English were included. Scoring systems were used for assessment of quality. The literature search identified 1039 papers. Thirty-four trials were included in the final review including 14,273 patients. There was overall a large variation in duration of convalescence. Trials using non-restrictive recommendations of 1-2days or "as soon as possible to return to all activities" reported overall a shorter duration of convalescence compared with trials not using recommendations for convalescence. Strenuous physical activity at work, strenuous leisure activity and patients with expectations of a prolonged period of convalescence may be risk factors for prolonged convalescence extending more than a few days after laparoscopic inguinal hernia repair. Patients should be recommended a duration of 1-2days of convalescence after laparoscopic inguinal hernia repair. Short and non-restrictive recommendations may reduce duration of convalescence without increasing risk of pain, complications or recurrence rate.

Open and Laparo-Endoscopic Repair of Incarcerated Abdominal Wall Hernias by the Use of Biological and Biosynthetic Meshes.

Although recently published guidelines recommend against the use of synthetic non-absorbable materials in cases of potentially contaminated or contaminated surgical fields due to the increased risk of infection (1, 2), the use of bio-prosthetic meshes for abdominal wall or ventral hernia repair is still controversially discussed in such cases. Bio-prosthetic meshes have been recommended due to less susceptibility for infection and the decreased risk of subsequent mesh explantation. The purpose of this review is to elucidate if there are any indications for the use of biological and biosynthetic meshes in incarcerated abdominal wall hernias based on the recently published literature. A literature search of the Medline database using the PubMed search engine, using the keywords returned 486 articles up to June 2015. The full text of 486 articles was assessed and 13 relevant papers were identified including 5 retrospective case cohort studies, 2 case-controlled studies, and 6 case series. The results of Franklin et al. (3-5) included the highest number of biological mesh repairs (Surgisis(®)) by laparoscopic IPOM in infected fields, which demonstrated a very low incidence of infection and recurrence (0.7 and 5.2%). Han et al. (6) reported in his retrospective study, the highest number of treated patients due to incarcerated hernias by open approach using acellular dermal matrix (ADM(®)) with very low rate of infection as well as recurrences (1.6 and 15.9%). Both studies achieved acceptable outcome in a follow-up of at least 3.5 years compared to the use of synthetic mesh in this high-risk population (7). Currently, there is a very limited evidence for the use of biological and biosynthetic meshes in strangulated hernias in either open or laparo-endoscopic repair. Finally, there is an urgent need to start with randomized controlled comparative trials as well as to support registries with data to achieve more knowledge for tailored indication for the use of biological meshes.