scholarly journals Effectiveness and cost-effectiveness of primary arthrodesis versus open reduction and internal fixation in patients with Lisfranc fracture instability (The BFF Study) study protocol for a multicenter randomized controlled trial

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
N. A. C. van den Boom ◽  
G. A. N. L. Stollenwerck ◽  
S. M. A. A. Evers ◽  
M. Poeze
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Internal Fixation ◽  
Study Protocol ◽  
Functional Outcomes ◽  
Open Reduction ◽  
Controlled Trial ◽  
Optimal Treatment ◽  
Fracture Dislocation

Abstract Background The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness. Methods Study design: A prospective multicenter RCT. Study population: All patients of 18 years and older with an acute (< 6 weeks) traumatic fracture dislocation in the Lisfranc midfoot joints, displaced on static radiographic evaluation or unstable with dynamic evaluation, weight bearing radiographs or fluoroscopic stress testing under anesthesia, and eligible for either one of the surgical procedures. In total, this study will include n = 112 patients with Lisfranc fracture dislocation. Interventions: Patients with Lisfranc fracture dislocation will be randomly allocated to treatment in “The Better to Fix or Fuse Study” (The BFF Study) with either PA or ORIF. Main study parameters/endpoints: Primary outcome parameter: the quality of life. Secondary outcomes: complications, functional outcomes, secondary surgical interventions and cost effectiveness. Nature and extent of the burden: PA is expected to have a better outcome, however both treatments are accepted for this injury with a similar low risk of complications. Follow up is standardized and therefore this study will not add extra burden to the patient. Discussion This study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic. Trial registration Current controlled Trial: NCT04519242 with registration date: 08/13/2020. Retrospectively registered; Protocol date and version: Version 4 05/06/2020

scholarly journals Cost-Effectiveness and Effects of a Home-Based Exercise Intervention for Female Caregivers of Relatives with Dementia: Study Protocol for a Randomized Controlled Trial

Healthcare ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 54 ◽  
Author(s):  
Miguel Madruga ◽  
Josué Prieto ◽  
Paloma Rohlfs ◽  
Narcís Gusi
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Physical Exercise ◽  
Study Protocol ◽  
Rural Areas ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Home Based

Previous research has proposed a range of support interventions to mitigate the adverse impact of caregiving on the daily life of caregivers of relatives with dementia. However, the effectiveness of these interventions shows a high variability. Informal caregivers usually lack the time and/or live too far from conventional facilities to do physical exercise, especially those who live in rural areas. Thus, home-based interventions may be more efficacious due to their greater convenience for this population. The present work proposes and describes a study protocol for a randomized control trial that will analyze the efficacy and cost-effectiveness of a home-based, structured individual physical exercise intervention to improve the health-related quality of life and the mental health of female informal caregivers of relatives with dementia. The nine-month-long intervention will comprise participation in two supervised physical exercise sessions per week at the caregiver’s home. The proposed study outcomes will be: (1) feasibility of and adherence to the home-based provision of the intervention; (2) improvement in physical fitness and quality of life; and (3) reduction in subjective burden, psychological symptomatology and depression. Analyses will also be performed to determine the cost-effectiveness after the intervention. In conclusion, this intervention might thus represent a tailored and feasible strategy to help caregivers cope with the physical and psychological stress resulting from caregiving-related responsibilities, and it could represent a novel cost-effective support home-based intervention for caregivers.

scholarly journals Efficacy of a Web-Enabled, School-Based, Preventative Intervention to Reduce Bullying and Improve Mental Health in Children and Adolescents: Study Protocol for a Cluster Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Covadonga M. Díaz-Caneja ◽  
Javier Martín-Babarro ◽  
Renzo Abregú-Crespo ◽  
Miguel Á. Huete-Diego ◽  
Marta Giménez-Dasí ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Bullying Victimization ◽  
Randomized Controlled ◽  
School Based ◽  
Cluster Randomized

Introduction: Bullying is a major preventable risk factor for mental disorders. Available evidence suggests school-based interventions reduce bullying prevalence rates. This study aims to test the efficacy of a web-enabled, school-based, multicomponent anti-bullying intervention to prevent school bullying and to assess its effects on mental health and quality of life.Methods and analysis: Cluster randomized controlled trial conducted in 20 publicly funded primary and secondary schools in Madrid, Spain. Schools are randomly allocated to either the intervention arm (n = 10) or conventional practices arm (n = 10). The web-enabled intervention (LINKlusive) lasts ~12 weeks and consists of three main components: (i) an online training program for teachers and parents, (ii) a web-guided educational program for students, focusing on promoting respect for diversity, empathy, and social skill development, and (iii) a web-guided, teacher-delivered, targeted intervention program for bullying situations identified based on peer-support strategies and individual intervention for those involved (i.e., bullying victims and perpetrators). The primary objective is to compare differences between peer-reported bullying victimization in the intervention and control arms at the end of the intervention. Secondary outcome measures are additional measures of bullying victimization and perpetration, mental health symptoms, self-esteem, and quality of life. A follow-up assessment is conducted 1 year after the end of the intervention. Treatment effects will be tested using multilevel mixed models, adjusting for school-, classroom-, and student-related covariates. Considering the increased bullying rates in children with special educational needs, a specific subgroup analysis will test the efficacy of the intervention on bullying prevalence, mental health, and quality of life in this particularly vulnerable population.Ethics and Dissemination: The Deontology Commission of the School of Psychology, Universidad Complutense in Madrid, Spain reviewed the study protocol and granted ethical approval on 21st January 2019. The results of the trial will be disseminated in relevant peer-reviewed journals and at conferences in the field.Trial Registration Number: ISRCTN15719015.

scholarly journals Evaluation of open reduction and internal fixation of proximal humerus fractures using a locking plate with smooth pegs – A retrospective study

2018 ◽  
Vol 11 (6) ◽  
pp. 411-418
Author(s):  
Frida Hansson ◽  
Magdalena Riddar ◽  
Anders Ekelund
Keyword(s):  
Quality Of Life ◽  
Retrospective Study ◽  
Internal Fixation ◽  
Avascular Necrosis ◽  
Open Reduction ◽  
Locking Plate ◽  
Constant Score ◽  
Humeral Fracture ◽  
The Mean

Background Optimal treatment of displaced proximal humeral fractures is controversial. This retrospective study aims to identify complications and clinical outcomes using a locking plate with smooth pegs instead of screws (S3 plate). Method Eighty-two patients with displaced proximal humeral fracture classified with 2–4 fragments (Neer’s classification) treated with open reduction and internal fixation (ORIF) with S3 plate were studied retrospectively. Clinical outcome according to constant score; Single Shoulder Value; Disabilities of Arm, Shoulder and Hand; and European Quality of life-5 dimensions and complication rate defined radiologically including peg penetration, avascular necrosis, and loss of reduction was assessed minimum 2.5 years after surgery. Results A total of 11 peg penetrations were identified (13.6%). Avascular necrosis was seen in 8.5% (n = 7). Mean constant score at follow-up was 64.4 with a relative constant score of 87% (standard deviation 18%) compared to the contralateral uninjured side. The mean Disabilities of Arm, Shoulder and Hand score was 12.7 and mean European Quality of life-5 dimensions score 0.83. The mean Single Shoulder Value was 78.3. No cases of deep infection were seen. Conclusions Fixation with S3 plate shows a proper osteosynthesis and the functional outcome is good. Symptomatic peg penetrations are rare and the incidence is lower compared to what has been reported with locked screws.

scholarly journals (Cost-)effectiveness of lower extremity nerve decompression surgery in subjects with diabetes: the DeCompression (DECO) trial—study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035644
Author(s):  
Willem D Rinkel ◽  
Tirzah M Fakkel ◽  
Manuel Castro Cabezas ◽  
Erwin Birnie ◽  
J Henk Coert
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Lower Extremity ◽  
Controlled Trial ◽  
Surgical Care ◽  
Life Questionnaire ◽  
Productivity Cost ◽  
Nerve Decompression

IntroductionThe peripheral nerves of patients with diabetes are often pathologically swollen, which results in entrapment at places of anatomical narrowing. This results in nerve dysfunction. Surgical treatment of compression neuropathies in the lower extremities (lower extremity nerve decompression (LEND)) results in relief of symptoms and gain in peripheral nerve function, which may lead to less sensory loss (short term) and less associated detrimental effects including foot ulceration and amputations, and lower costs (long term). The aim of the DeCompression trial is to evaluate the effectiveness and (cost-)effectiveness of surgical decompression of compressed lower extremity nerves (LEND surgery) compared with patients treated with conventional (non-surgical) care.Methods and analysisA stratified randomised (1 to 1) controlled trial comparing LEND surgery (intervention) with conventional non-surgical care (control strategy) in subjects with diabetes with problems of neuropathy due to compression neuropathies in the lower extremity. Randomisation is stratified for participating hospital (n=11) and gender. Patients and controls have the same follow-up at 1.5, 3, 6, 9, 12, 18, 24 and 48 months. Participants (n=344) will be recruited in 12 months and enrolled in all affiliated hospitals in which they receive both the intervention or conventional non-surgical care and follow-up. Outcome assessors are blinded to group assignment. Primary outcome: disease-specific quality of life (Norfolk Quality of Life Questionnaire—Diabetic Neuropathy). Secondary outcomes: health-related quality of life (EuroQoL 5-dimension 5-level (EQ-5D5L), 36-item Short Form (SF-36)), plantar sensation (Rotterdam Diabetic Foot Test Battery), incidence of ulcerations/amputations, resource use and productivity loss (Medical Cost Questionnaire, Productivity Cost Questionnaire) during follow-up. The incremental cost-effectiveness ratio will be estimated on the basis of the collected empirical data and a cost-utility model.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Utrecht University Medical Center (reference: NL68312.041.19v5, protocol number: 19-335/M). Dissemination of results will be via journal articles and presentations at national and international conferences.Trial registration numberNetherlandsTrial Registry NL7664.

scholarly journals SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study

2020 ◽  
Vol 2020 (1) ◽  
Author(s):  
E van Barneveld ◽  
V B Veth ◽  
J M Sampat ◽  
A M F Schreurs ◽  
M van Wely ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Deep Endometriosis ◽  
Ovarian Endometrioma ◽  
Randomised Controlled

Abstract STUDY QUESTIONS The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (−30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN, SIZE, DURATION This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS, SETTING, METHODS Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTEREST(S) This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE 2 January 2019 DATE OF FIRST PATIENT’S ENROLMENT First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.

scholarly journals Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial

Trials ◽  
2012 ◽  
Vol 13 (1) ◽  
Author(s):  
Paulo de Tarso Camillo de Carvalho ◽  
Ernesto Cesar Pinto Leal-Junior ◽  
Ana Carolina Araruna Alves ◽  
Caroline Sobral de Melo Rambo ◽  
Luciana Maria Malosa Sampaio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Laser Therapy ◽  
Study Protocol ◽  
Controlled Trial ◽  
Low Level Laser Therapy ◽  
Randomized Controlled ◽  
Level Laser ◽  
Double Blinded
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