ABSTRACT
BACKGROUND: There has been an increase in the integration of qualitative studies in randomised controlled trials. The purpose of this article is to reflect on our experience of carrying out a rapid qualitative study during a feasibility trial of goal-directed fluid therapy (GDFT) in patients with acute pancreatitis, including our sharing of emerging findings and the use of these findings by the trial team. METHODS: The study was designed as a rapid feedback evaluation and combined interviews with staff and patients who took part in the trial. FINDINGS: The rapid qualitative study pointed to common problems in trial recruitment among multiple sites, where lack of engagement of clinical teams across sites might impact negatively on patient recruitment. The article describes how the use of rapid feedback loops can be used as the trial is ongoing to inform changes in implementation. It also covers the potential challenges of working rapidly and collaborative with the trial team. CONCLUSIONS: Rapid feedback evaluations can be used to generate findings across all stages of trial design and delivery. Additional research is required to explore the implementation of this research design in other settings and trial designs.
Subject(s)
Pancreatitis , Humans , Pancreatitis/diagnosis , Pancreatitis/therapy , Feasibility Studies , Acute Disease , Goals , Qualitative Research , Fluid Therapy/adverse effectsABSTRACT
OBJECTIVE: To analyse the current difference between dismembered robot-assisted pyeloplasty (RAP) and laparoscopic pyeloplasty (LP) in the treatment of pelvi-ureteric junction (PUJ) obstruction as of 26 June 2017, focusing on operating time, length of hospital stay, complication rate, and success rate. PATIENTS AND METHODS: We searched PubMed, Medline and Embase databases, consulted experts, reviewed reference lists, used the 'related articles' PubMed feature, and reviewed scientific meeting abstracts for eligible articles published between 1993 and 26 June 2017. A modified Newcastle-Ottawa scale was used to assess study quality. Subgroup analyses were performed regarding patient age, single or multisurgeon experience, presence of complex renal anatomy, study quality, Clavien-Dindo grades, and length of follow-up. RESULTS: From 4101 identified articles, 17 studies meeting our eligibility criteria were included for data extraction. All were observational studies, with 10 deemed to be of low quality. Meta-analysis showed that RAP resulted in a 27-min shorter operating time (weighted mean difference [WMD] -26.71 min, 95% confidence interval [CI] -44.42 to -9.00; P = 0.003) and a 1.2-day shorter length of hospital stay (WMD -1.21 days, 95% CI -1.84 to -0.57; P = 0.003). The quality of evidence for these outcomes was rated as very low. Significant heterogeneity was found when analysing operating time (P < 0.001) and length of hospital stay (P < 0.001), which could not be fully explained through subgroup analyses. We also identified other potentially significant sources of bias for which we could not adjust our analysis. RAP was also associated with a lower complication rate (odds ratio [OR] 0.56, 95% CI 0.37 to 0.84; P = 0.005) and higher success rate (OR 2.76, 95% CI 1.30 to 5.88; P = 0.008); however, whether statistical advantages for these two outcomes translated into clinically significant advantages was unclear. The quality of evidence for these outcomes was rated as low. CONCLUSION: For patients with PUJ obstruction, our meta-analyses show that RAP is advantageous concerning operating time, length of hospital stay, complication rate and success rate. Our conclusions, however, are weakened by poor quality of evidence and significant study heterogeneity. In addition, whether the statistical significance observed in the present meta-analysis translates into clinical significance is an important question. Further high-quality studies, particularly randomized controlled trials, are necessary to strengthen conclusions.
