Development of an online resource for recruitment research in clinical trials to organise and map current literature.

BACKGROUND: Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research. METHODS: MEDLINE (Ovid), Scopus, Cochrane Database of Systematic Reviews and Cochrane Methodology Register, Science Citation Index Expanded and Social Sciences Citation Index within the ISI Web of Science and Education Resources Information Center were searched in January 2015. Search strategy results were screened by title and abstract, and full text obtained for potentially eligible articles. Studies reporting or evaluating strategies, interventions or methods used to recruit patients were included along with case reports and studies exploring reasons for patient participation or non-participation. Eligible articles were categorised as systematic reviews, nested randomised controlled trials and other designs evaluating the effects of recruitment strategies (Level 1); studies that report the use of recruitment strategies without an evaluation of impact (Level 2); or articles reporting factors affecting recruitment without presenting a particular recruitment strategy (Level 3). Articles were also assigned to 1, or more, of 42 predefined recruitment domains grouped under 6 categories. RESULTS: More than 60,000 records were retrieved by the search, resulting in 56,030 unique titles and abstracts for screening, with a further 23 found through hand searches. A total of 4570 full text articles were checked; 2804 were eligible. Six percent of the included articles evaluated the effectiveness of a recruitment strategy (Level 1), with most of these assessing aspects of participant information, either its method of delivery (33%) or its content and format (28%). DISCUSSION: Recruitment to clinical trials remains a common challenge and an important area for future research. The online resource for Recruitment Research in Clinical triAls project provides a searchable, online database of research relevant to recruitment. The project has identified the need for researchers to evaluate their recruitment strategies to improve the evidence base and broaden the narrow focus of existing research to help meet the complex challenges faced by those recruiting to clinical trials.

Registration and publication of emergency and elective randomised controlled trials in surgery: a cohort study from trial registries.

OBJECTIVES: Emergency surgical practice constitutes 50% of the workload for surgeons, but there is a lack of high quality randomised controlled trials (RCTs) in emergency surgery. This study aims to establish the differences between the registration, completion and publication of emergency and elective surgical trials. DESIGN: The clinicaltrials.gov and ISRCTN.com trials registry databases were searched for RCTs between 12 July 2010 and 12 July 2012 using the keyword 'surgery'. Publications were systematically searched for in Pubmed, MEDLINE and EMBASE. PARTICIPANTS: Results with no surgical interventions were excluded. The remaining results were manually categorised into 'emergency' or 'elective' and 'surgical' or 'adjunct' by two reviewers. PRIMARY OUTCOME MEASURES: Number of RCTs registered in emergency versus elective surgery. SECONDARY OUTCOME MEASURES: Number of RCTs published in emergency versus elective surgery; reasons why trials remain unpublished; funding, sponsorship and impact of published articles; number of adjunct trials registered in emergency and elective surgery. RESULTS: 2700 randomised trials were registered. 1173 trials were on a surgical population and of these, 414 trials were studying surgery. Only 9.4% (39/414) of surgical trials were in emergency surgery. The proportion of trials successfully published did not significantly differ between emergency and elective surgery (0.46 vs 0.52; mean difference (MD) -0.06, 95% CI -0.24 to 0.12). Unpublished emergency surgical trials were statistically equally likely to be terminated early compared with elective trials (0.33 vs 0.16; MD -0.18, 95% CI -0.06 to 0.41). Low accrual accounted for a similar majority in both groups (0.43 vs 0.46; MD -0.04, 95% CI -0.48 to 0.41). Unpublished trials in both groups were statistically equally likely to still be planning publication (0.52 vs 0.71; MD -0.18, 95% CI -0.43 to 0.07). CONCLUSION: Fewer RCTs are registered in emergency than elective surgery. Once trials are registered both groups are equally likely to be published.

Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital.

OBJECTIVES: To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. DESIGN: Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. RESULTS: Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more 'real' RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. CONCLUSION: There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment.

Intracavity lavage and wound irrigation for prevention of surgical site infection.

BACKGROUND: Surgical site infections (SSIs) are wound infections that occur after an operative procedure. A preventable complication, they are costly and associated with poorer patient outcomes, increased mortality, morbidity and reoperation rates. Surgical wound irrigation is an intraoperative technique, which may reduce the rate of SSIs through removal of dead or damaged tissue, metabolic waste, and wound exudate. Irrigation can be undertaken prior to wound closure or postoperatively. Intracavity lavage is a similar technique used in operations that expose a bodily cavity; such as procedures on the abdominal cavity and during joint replacement surgery. OBJECTIVES: To assess the effects of wound irrigation and intracavity lavage on the prevention of surgical site infection (SSI). SEARCH METHODS: In February 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus. We also searched three clinical trials registries and references of included studies and relevant systematic reviews. There were no restrictions on language, date of publication or study setting. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) of participants undergoing surgical procedures in which the use of a particular type of intraoperative washout (irrigation or lavage) was the only systematic difference between groups, and in which wounds underwent primary closure. The primary outcomes were SSI and wound dehiscence. Secondary outcomes were mortality, use of systemic antibiotics, antibiotic resistance, adverse events, re-intervention, length of hospital stay, and readmissions. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion at each stage. Two review authors also undertook data extraction, assessment of risk of bias and GRADE assessment. We calculated risk ratios or differences in means with 95% confidence intervals where possible. MAIN RESULTS: We included 59 RCTs with 14,738 participants. Studies assessed comparisons between irrigation and no irrigation, between antibacterial and non-antibacterial irrigation, between different antibiotics, different antiseptics or different non-antibacterial agents, or between different methods of irrigation delivery. No studies compared antiseptic with antibiotic irrigation. Surgical site infectionIrrigation compared with no irrigation (20 studies; 7192 participants): there is no clear difference in risk of SSI between irrigation and no irrigation (RR 0.87, 95% CI 0.68 to 1.11; I2 = 28%; 14 studies, 6106 participants). This would represent an absolute difference of 13 fewer SSIs per 1000 people treated with irrigation compared with no irrigation; the 95% CI spanned from 31 fewer to 10 more SSIs. This was low-certainty evidence downgraded for risk of bias and imprecision.Antibacterial irrigation compared with non-antibacterial irrigation (36 studies, 6163 participants): there may be a lower incidence of SSI in participants treated with antibacterial irrigation compared with non-antibacterial irrigation (RR 0.57, 95% CI 0.44 to 0.75; I2 = 53%; 30 studies, 5141 participants). This would represent an absolute difference of 60 fewer SSIs per 1000 people treated with antibacterial irrigation than with non-antibacterial (95% CI 35 fewer to 78 fewer). This was low-certainty evidence downgraded for risk of bias and suspected publication bias.Comparison of irrigation of two agents of the same class (10 studies; 2118 participants): there may be a higher incidence of SSI in participants treated with povidone iodine compared with superoxidised water (Dermacyn) (RR 2.80, 95% CI 1.05 to 7.47; low-certainty evidence from one study, 190 participants). This would represent an absolute difference of 95 more SSIs per 1000 people treated with povidone iodine than with superoxidised water (95% CI 3 more to 341 more). All other comparisons found low- or very low-certainty evidence of no clear difference between groups.Comparison of two irrigation techniques: two studies compared standard (non-pulsed) methods with pulsatile methods. There may, on average, be fewer SSIs in participants treated with pulsatile methods compared with standard methods (RR 0.34, 95% CI 0.19 to 0.62; I2 = 0%; two studies, 484 participants). This would represent an absolute difference of 109 fewer SSIs occurring per 1000 with pulsatile irrigation compared with standard (95% CI 62 fewer to 134 fewer). This was low-certainty evidence downgraded twice for risks of bias across multiple domains. Wound dehiscenceFew studies reported wound dehiscence. No comparison had evidence for a difference between intervention groups. This included comparisons between irrigation and no irrigation (one study, low-certainty evidence); antibacterial and non-antibacterial irrigation (three studies, very low-certainty evidence) and pulsatile and standard irrigation (one study, low-certainty evidence). Secondary outcomesFew studies reported outcomes such as use of systemic antibiotics and antibiotic resistance and they were poorly and incompletely reported. There was limited reporting of mortality; this may have been partially due to failure to specify zero events in participants at low risk of death. Adverse event reporting was variable and often limited to individual event types. The evidence for the impact of interventions on length of hospital stay was low or moderate certainty; where differences were seen they were too small to be clinically important. AUTHORS' CONCLUSIONS: The evidence base for intracavity lavage and wound irrigation is generally of low certainty. Therefore where we identified a possible difference in the incidence of SSI (in comparisons of antibacterial and non-antibacterial interventions, and pulsatile versus standard methods) these should be considered in the context of uncertainty, particularly given the possibility of publication bias for the comparison of antibacterial and non-antibacterial interventions. Clinicians should also consider whether the evidence is relevant to the surgical populations under consideration, the varying reporting of other prophylactic antibiotics, and concerns about antibiotic resistance.We did not identify any trials that compared an antibiotic with an antiseptic. This gap in the direct evidence base may merit further investigation, potentially using network meta-analysis; to inform the direction of new primary research. Any new trial should be adequately powered to detect a difference in SSIs in eligible participants, should use robust research methodology to reduce the risks of bias and internationally recognised criteria for diagnosis of SSI, and should have adequate duration and follow-up.

Medium-Term Recurrence and Quality of Life Assessment Using the Hernia-Specific Carolinas Comfort Scale Following Laparoscopic Inguinal Hernia Repair.

OBJECTIVES: To determine the long-term outcomes and quality of life (QoL) following laparoscopic mesh repair of inguinal hernias using the hernia-specific Carolinas Comfort Scale(®) (CCS) questionnaire (Carolinas Laparoscopic and Advanced Surgery Program, Carolinas HealthCare System, Charlotte, NC). MATERIALS AND METHODS: All patients who underwent elective primary or recurrent laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair from January 2005 to May 2010 were identified from a prospectively maintained clinical database. Baseline patient characteristics were recorded, including occupation, in addition to mean operating time, hernia recurrence rates, and postoperative CSS. RESULTS: Four hundred fifty-nine patients underwent surgery during the study period. The median follow-up interval from the date of operation to the date the questionnaire sent was 23 months (interquartile range, 32 months), and the total number of valid responses was 250. The median age of patients was 58 years (interquartile range, 21 years). The median operating time was 42 minutes (interquartile range, 21 minutes). Thirty-five patients (15%) and 15 patients (12%) had bilateral and recurrent hernia repairs, respectively. Three patients (1.1%) were confirmed to have hernia recurrence. Analysis of the CSS scores revealed that 41 patients (16%) reported pain, 44 (18%) reported mesh sensation, and 25 (10%) reported movement limitation. However, severe or disabling mesh-related symptoms were present in 5 patients (2%) for the pain category, in 8 patients (3%) for the mesh sensation category, and in 9 patients (3%) for the movement limitation symptom. The number of patients who were completely asymptomatic in all three symptom categories was 190 (24%). The only significant risk factor for developing mesh-related symptoms was young age at the time of surgery. CONCLUSIONS: Patient-reported medium-term symptoms following laparoscopic inguinal hernia repair appear common; however, the prevalence of severe or disabling symptoms is low.

Surgical ward rounds in England: a trainee-led multi-centre study of current practice.

BACKGROUND: Recent guidance advocates daily consultant-led ward rounds, conducted in the morning with the presence of senior nursing staff and minimising patients on outlying wards. These recommendations aim to improve patient management through timely investigations, treatment and discharge. This study sought to evaluate the current surgical ward round practices in England. METHODS: Information regarding timing and staffing levels of surgical ward rounds was collected prospectively over a one-week period. The location of each patient was also documented. Two surgical trainee research collaboratives coordinated data collection from 19 hospitals and 13 surgical subspecialties. RESULTS: Data from 471 ward rounds involving 5622 patient encounters was obtained. 367 (77.9%) ward rounds commenced before 9am. Of 422 weekday rounds, 190 (45%) were consultant-led compared with 33 of the 49 (67%) weekend rounds. 2474 (44%) patients were seen with a nurse present. 1518 patients (27%) were classified as outliers, with 361 ward rounds (67%) reporting at least one outlying patient. CONCLUSION: Recommendations for daily consultant-led multi disciplinary ward rounds are poorly implemented in surgical practice, and patients continue to be managed on outlying wards. Although strategies may be employed to improve nursing attendance on ward rounds, substantial changes to workforce planning would be required to deliver daily consultant-led care. An increasing political focus on patient outcomes at weekends may prompt changes in these areas.