Randomised trial support for orthopaedic surgical procedures.
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ABSTRACT:
SUBMITTER: Lim HC
PROVIDER: S-EPMC4057075 | biostudies-literature | 2014
REPOSITORIES: biostudies-literature
Publications
Randomised trial support for orthopaedic surgical procedures.
Lim Hyeung C HC Adie Sam S Naylor Justine M JM Harris Ian A IA
PloS one 20140613 6
We investigated the proportion of orthopaedic procedures supported by evidence from randomised controlled trials comparing operative procedures to a non-operative alternative. Orthopaedic procedures conducted in 2009, 2010 and 2011 across three metropolitan teaching hospitals were identified, grouped and ranked according to frequency. Searches of the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Revie ...[more]
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Project description:IntroductionThe quantity and quality of surgical training in the UK has been negatively affected by reduced working hours and National Health Service (NHS) financial pressures. Traditionally surgical training has occurred by the master-apprentice model involving a process of graduated responsibility, but a modern alternative is to use simulation for the early stages of training. It is not known if simulation training for junior trainees can safeguard patients and improve clinical outcomes. This paper details the protocol for a multicentre randomised controlled educational trial of a cadaveric simulation training intervention versus standard training for junior postgraduate orthopaedic surgeons-in-training. This is the first study to assess the effect of cadaveric simulation training for open surgery on patient outcome. The feasibility of delivering cadaveric training, use of radiographic and clinical outcome measures to assess impact and the challenges of upscaling provision will be explored.Methods and analysisWe will recruit postgraduate orthopaedic surgeons-in-training in the first 3 years (of 8) of the specialist training programme. Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial. The procedures are (1) dynamic hip screw, (2) hemiarthroplasty and (3) ankle fracture fixation. These procedures have been selected as they are very common procedures which are routinely performed by junior surgeons-in-training. A pragmatic approach to sample size is taken in lieu of a formal power calculation as this is novel exploratory work with no a priori estimate of effect size to reference. The primary outcome measure is the technical success of the surgery performed on patients by the participating surgeons-in-training during the follow-up period for the three substudy procedures, as measured by the implant position on the postoperative radiograph. The secondary outcome measures are procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D-substudies 1 and 2 only).Ethics, registration and disseminationNational research ethics approval was granted for this study by the NHS Research Authority South Birmingham Research Ethics Committee (15/WM/0464). Confidentiality Advisory Group approval was granted for accessing radiographic and outcome data without patient consent on 27 February 2017 (16/CAG/0125). The results of this trial will be submitted to a peer-reviewed journal and will inform educational and clinical practice.Trial registration numberISRCTN20431944.
| S-EPMC7520841 | biostudies-literature
Project description:BackgroundColon cancer is one of the most common cancers in Finland and worldwide. Cancer-related malnutrition is a well-known risk factor for increased morbidity and mortality after surgery, and it is associated with complications and longer hospitalizations. There are no established recommendations on how to improve the nutritional status of colon cancer patients´ during the perioperative phase. Administration of simple oral nutritional supplements has been suggested to reduce complication rates, but evidence to support this practice is scarce.MethodsThe Peri-Nutri trial is a prospective, multicenter, randomized, controlled trial. Its primary endpoint is to evaluate whether perioperative oral nutritional support (ONS) decreases the number of complications during the 30-day follow-up after surgery. Secondary endpoints are to study the effect of ONS on quality of life after surgery, length of stay in institutional care, 90-day mortality rate, five-year disease-free survival and overall survival. The patients with a Nutritional risk screening 2002 (NRS-2002) questionnaire result between 2 and 5 (≥ 3 are classified at risk of malnutrition) will be randomized (1:1 ratio) into either the intervention or control group. The intervention group will receive preoperative ONS two weeks before the operation, and nutritional support will continue 10 days after the operation. The control group will not receive ONS. A total of 318 patients will be randomized into two groups and patients are followed five years.DiscussionPeri-Nutri study evaluate the impact of ONS to short-term and long-term postoperative morbidity and mortality rates of colon cancer patients undergoing curative surgery. If ONS will decrease patients´ morbidity and mortality, that has a huge impact on patients´ quality of life and also to financial cost.Trial registrationClinicalTrials.gov, NCT03863236 , Registered 25 February 2019.
| S-EPMC9438122 | biostudies-literature
Project description:BackgroundDecentralised services using outreach clinics or modern technology are methods to reduce both patient transports and costs to the healthcare system. Telemedicine consultations via videoconference are one such modality. Before new technologies are implemented, it is important to investigate both the quality of care given and the economic impact from the use of this new technology. The aim of this clinical trial was to study the quality of planned remote orthopaedic consultations by help of videoconference.MethodWe performed a randomised controlled trial (RCT) with two parallel groups: video-assisted remote consultations at a regional medical centre (RMC) as an intervention versus standard consultation in the orthopaedic outpatient clinic at the University Hospital of North Norway (UNN) as a control. The participants were patients referred to or scheduled for a consultation at the orthopaedic outpatient clinic. The orthopaedic surgeons evaluated each consultation they performed by completing a questionnaire. The primary outcome measurement was the difference in the sum score calculated from this questionnaire, which was evaluated by the non-inferiority of the intervention group. The study design was based on the intention to treat principle. Ancillary analyses regarding complications, the number of consultations per patient, operations, patients who were referred again and the duration of consultations were performed.ResultsFour-hundred patients were web-based randomised. Of these, 199 (98 %) underwent remote consultation and 190 (95 %) underwent standard consultation. The primary outcome, the sum score of the specialist evaluation, was significantly lower (i.e. 'better') at UNN compared to RMC (1.72 versus 1.82, p = 0.0030). The 90 % confidence interval (CI) for the difference in score (0.05, 0.17) was within the non-inferiority margin. The orthopaedic surgeons involved evaluated 98 % of the video-assisted consultations as 'good' or 'very good'. In the ancillary analyses, there was no significant difference between the two groups.ConclusionsThis study supports the argument that it is safe to offer video-assisted consultations for selected orthopaedic patients. We did not find any serious events related to the mode of consultation. Further assessments of the economic aspects and patient satisfaction are needed before we can recommend its wider application.Trial registrationClinicalTrials.gov identifier: NCT00616837.
| S-EPMC5017045 | biostudies-literature
Project description:BackgroundInappropriate staff behaviour during surgical procedures may disrupt the surgical performance and compromise patient safety. We developed an innovative monitoring and feedback system combined with an adaptive approach to optimise staff behaviour intraoperatively and prevent post-operative complications (POC) in orthopaedic surgery.Methods/designThis protocol describes a parallel-group, cluster randomised, controlled trial with orthopaedic centre as the unit of randomisation. The intervention period will last 6 months and will be based on the monitoring of two surrogates of staff behaviour: the frequency of doors opening and the level of noise. Both will be collected from incision to wound closure, using wireless sensors and sonometers, and recorded and analysed on a dedicated platform (Livepulse®). Staff from centres randomised to the intervention arm will be informed in real time on their own data through an interactive dashboard available in each operating room (OR), and a posteriori for hip and knee replacement POC. Aggregated data from all centres will also be displayed for benchmarking. A lean method will be applied in each centre by a local multidisciplinary team to analyse baseline situations, determine the target condition, analyse the root cause(s), and take countermeasures. The education and awareness of participants on the impact of their behaviour on patient safety will assist the quality improvement process. The control centres will be blinded to monitoring data and quality improvement approaches. The primary outcome will be any POC occurring during the 30 days post operation. We will evaluate this outcome using local and national routinely collected data from hospital discharge and disease databases. Thirty orthopaedic centres will be randomised for a total of 9945 hip and knee replacement surgical procedures.DiscussionThe field of human factors and behaviour in the OR seems to offer potential room for improvement. An intervention providing goal-setting, monitoring, feedback and action planning may reduce the traffic flow and interruptions/distractions of the surgical team during procedures, preventing subsequent POCs. The results of this trial will provide important data on the impact of OR staff behaviour on patient safety, and promote best practice during surgical procedures.Trial registrationClinicalTrials.gov, NCT03158181 .
| S-EPMC6528209 | biostudies-literature
Project description:We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families.Prospective, pragmatic, individually randomised controlled trial.3 Maternity Trusts in West Midlands, UK.Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded.POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms.Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8-12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8-12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems.Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) -0.00, 95% CI (95% CI -0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD -0.79 (95% CI -1.56 to -0.02) was significantly better, although for all women recruited, no significant differences were seen (MD -0.59 (95% CI -1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group for all women (MD -0.30 (95% CI -0.61 to -0.00) p=0.05), and there were no differences in other secondary outcomes.This trial demonstrates differences in depressive symptomatology with addition of the POW service in the powered subgroup of women with 2 or more social risk factors. Addition to existing evidence indicates benefit from lay interventions in preventing postnatal depression. This finding is important for women and their families given the known effect of maternal depression on longer term childhood outcomes.ISRCTN35027323; Results.
| S-EPMC4785315 | biostudies-other
Project description:Every surgical wound is colonized by bacteria, but only a small percentage displays symptoms of infection. The distribution of pathogens isolated in surgical site infections has not significantly changed over the last decades. Staph. Aureus, Coag(-) Staphylococci, Enterococcus spp and E. Coli are the main strains appearing. In addition, a continuously rising proportion of surgical site infections caused by resistant bacterial species (MRSA, C. Albicans) has been reported.This prospective and randomized clinical study was performed in the 1st Surgical Clinic of Sismanoglion General Hospital of Athens, from February 2009 to February 2015. Patients undergoing elective surgery in the upper or lower digestive system were randomized to receive antimicrobial treatment as chemoprophylaxis. Each patient filled a special monitoring form, recording epidemiological data, surgery related information, surgical site infections (deep and superficial), as well as postoperative morbidity (urinary and respiratory infections included). The monitoring of patients was carried by multiple visits on a daily basis during their hospitalization and continued after they were discharged via phone to postoperative day 30.Our overall SSI incidence was 4,3% (31patients out of a whole of 715 patients). Specifically, the incidence of SSIs for scheduled surgery of the upper GI tract was 2,2% (11 out of 500 patients) and for the lower GI tract was 9,3% (20 out of 215 patients). Seven main pathogens were isolated from patients with SSIs: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Pseudomonas aeruginosa, Bacteroides fragilis, Staphylococcus aureus and Enterococcus faecalis. Their growth rates were respectively: S. Aureus (17,3%), E. faecalis (19,5%), P. aeruginosa (10,5%), B. Fragilis (13,4%) E. coli (20,4%), Enterobacter cloacae (9,1%) and K. Pneumoniae (9,8%). In addition, all the SSIs were found to be multimicrobial. Several studies have already revealed that patient characteristics and coexisting morbidities such as obesity, smoking, heart or renal failure, pre-existing localized infections and patients' age (especially if age exceeds 65) seem to be independent prognostic factors for surgical field infections. Additionally, classification of the surgical wound, surgical operation complexity, preoperative hospitalization, prolongation of surgical time and need for transfusions have been proved to differentiate the incidence of SSIs.In conclusion, surgical site infections are important complications affecting the healthcare services, the cost of hospitalization and the patient himself. Future thorough studies are expected to reveal much more data, regarding predisposing and precautionary patient and hospital characteristics.
| S-EPMC5524225 | biostudies-other
Project description:BackgroundSurgical site infections (SSIs) after elective orthopaedic surgery are very stressful for patients due to frequent rehospitalizations with reoperations and poorer functional outcomes. Prevention of such events is therefore crucial. Although an evidence-based consensus is still lacking, preoperative decolonization could decrease SSI. Specifically, more information is needed about the effect of a preoperative decolonization procedure on SSI proportions in both Staphylococcus aureus carriers and non-S. aureus carriers after general orthopaedic surgery.Questions/purposesOur study addressed the following questions: (1) Does preoperative decolonization reduce the risk of SSI after general elective orthopaedic surgery in patients colonized with S. aureus? (2) Does preoperative decolonization reduce the risk of SSI among patients who are not colonized with S. aureus?MethodsIn this prospective, randomized, single-blinded trial, we recruited patients undergoing general elective orthopaedic surgery in one tertiary care center in Switzerland. Between November 2014 and September 2017, 1318 of 1897 screened patients were enrolled. Patients were allocated into either the S. aureus carrier group (35%, 465 of 1318 patients) or the noncarrier group (65%, 853 of 1318 patients) according to screening culture results. In the S. aureus group, 232 patients were allocated to the intervention arm and 233 were allocated to the control arm. Intervention was 5 days of daily chlorhexidine showers and mupirocin nasal ointment twice a day. Of the 853 noncarriers, 426 were allocated to the intervention arm and 427 were allocated to the control arm. All patients in both groups were analyzed in an intention-to-treat manner. The primary endpoint was SSI occurrence at 90 days postoperative and the secondary endpoint was SSI occurrence at 30 days postoperative.The initial sample size calculation was made for the S. aureus carrier group. Based on the literature review, a 4% proportion of SSI was expected in the control group. Thus, 726 carriers would have been needed to detect a relative risk reduction of 80% with a power of 80% at a two-sided α-error of 0.048 (adjusted for interim analysis). Assuming carrier prevalence of 27%, 2690 patients would have been needed in total. An interim analysis was performed after including half of the targeted S. aureus carriers (363 of 726). Based on the low infection rate in the control group (one of 179), a new sample size of 15,000 patients would have been needed. This was deemed not feasible and the trial was stopped prematurely.ResultsAmong carriers, there was no difference in the risk of SSI between the intervention and control arms (decolonized SSI risk: 0.4% [one of 232], control SSI risk: 0.4% [one of 233], risk difference: 0.0% [95% CI -1.2% to 1.2%], stratified for randomization stratification factors; p > 0.999). For noncarriers, there was no difference in risk between the intervention and control arms (decolonized SSI risk: 0.2% [one of 426], control SSI risk: 0.2% [one of 247], stratified risk difference: -0.0% [95% CI -0.7 to 0.6]; p = 0.973).ConclusionsWe found no difference in the risk of SSI between the decolonization and control groups, both in S. aureus carriers and noncarriers. Because of the low event numbers, no definite conclusion about efficacy of routine preoperative decolonization can be drawn. The results, however, may be helpful in future meta-analyses.Level of evidenceLevel II, therapeutic study.
| S-EPMC7371089 | biostudies-literature
Project description:ObjectiveTo synthesize evidence on physical activity interventions that used wearables, either alone or in combination with education or rehabilitation, in adults following orthopaedic surgical procedures.MethodsPubMed, CINAHL, PsycINFO and EMBASE were searched for randomized controlled trials of wearable-based interventions from each database's inception to August 2021 in patients undergoing orthopaedic surgery. Relevant outcomes included physical activity, physical function, pain, psychological distress, or general health. PEDro scale scoring ranges from 0 to 10 and was used to appraise studies as high (≥7), moderate (5-6), or poor (<5) quality.ResultsOf 335 articles identified, 6 articles met eligibility criteria. PEDro scores ranged from 2 to 6, with 3 studies of moderate quality and 3 of poor quality. Studies included patients undergoing total knee (number; n = 4) or total knee or hip (n = 1) arthroplasty and lumbar disc herniation surgery (n = 1). In addition to wearables, intervention components included step diary (n = 2), motivational interviewing (n = 1), goal setting (n = 2), tailored exercise program (n = 2), or financial incentives (n = 1). Interventions were delivered in-person (n = 2), remotely (n = 3) or in a hybrid format (n = 1). Intervention duration ranged from 6 weeks to 6 months. Compared to controls, 3 moderate quality studies reported greater improvement in steps/day; however, 1 moderate and 2 poor quality studies showed no between-group difference in physical function, pain, or quality of life. No serious adverse events related to the use of wearable were reported.ConclusionsThe effects of physical activity interventions using wearables, either delivered in-person or remotely, appear promising for increasing steps per day after joint arthroplasty; however, this finding should be viewed with caution since it is based on 3 moderate quality studies. Further research is needed to determine the therapeutic effects of using wearables as an intervention component in patients undergoing other orthopaedic surgical procedures.Trial registrationPROSPERO Registration Number: CRD42020186103.
| S-EPMC8846530 | biostudies-literature
Project description:IntroductionThere is controversy regarding the importance of air-transmitted infections for surgical site infections (SSIs) after orthopaedic surgery. Research has been hindered by both the inability in blinding the exposure, and by the need for recruiting large enough cohorts. The aim of this study is to investigate whether using a new form of air purifier using plasma air purification (PAP) in operating rooms (ORs) lowers the SSI rate or not.Methods and analysisMulticentre, double-blind, cluster-randomised, placebo-controlled trial conducted at seven hospitals in 2017-2022. All patients that undergo orthopaedic surgery for minimum 30 min are included. Intervention group: patients operated in OR with PAP devices turned on.Control grouppatients operated in OR with PAP devices turned off. Randomisation: each OR will be randomised in periods of 4 weeks, 6 weeks or 8 weeks to either have the devices on or off.Primary outcomeany SSI postoperatively defined as a composite endpoint of any of the following: use of isoxazolylpenicillin, clindamycin or rifampicin for 2 days or more, International Classification of Diseases codes or Nordic Medico-Statistical Committee codes indicating postoperative infection. In a second step, we will perform a chart review on those patients with positive indicators of SSI to further validate the outcome. Secondary outcomes are described in the Methods section. Power: we assume an SSI rate of 2%, an SSI reduction rate of 25% and we need approximately 45 000 patients to attain a power of 80% at a significance level of 0.05.Ethics and disseminationThe study is approved by the Swedish Ethical Review Authority. The interim analysis results from the study will be presented only to the researchers involved unless the study thereafter is interrupted for whatever reason. Publication in a medical journal will be presented after inclusion of the last patient.Trial registration numberNCT02695368.
| S-EPMC8814745 | biostudies-literature
Project description:BackgroundRecruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research.DesignTwo qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically.SettingNHS secondary care organisations throughout the UK. Interviews were undertaken via telephone.ParticipantsThirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed.ResultsWe used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient's circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients' treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated.ConclusionsA wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials.Trial registrationACTIVE: ( ISRCTN98152560 ). Registered on 06/03/2018. PRESTO: ( ISRCTN12094890 ). Registered on 22/02/2018.
| S-EPMC8285860 | biostudies-literature