A systematic review of reporting quality for anaesthetic interventions in randomised controlled trials

Interventions from randomised controlled trials can only be replicated if they are reported in sufficient detail. The results of trials can only be confidently interpreted if the delivery of the intervention was systematic and the protocol adhered to. We systematically reviewed trials of anaesthetic interventions published in 12 journals from January 2016 to September 2019. We assessed the detail with which interventions were reported, using the Consolidated Standards of Reporting Trials statement for non-pharmacological treatments. We analysed 162 interventions reported by 78 trials in 18,675 participants. Detail sufficiently precise to replicate the intervention was reported for 111 (69%) interventions. Intervention standardisation was reported for 135 (83%) out of the 162 interventions, and protocol adherence was reported for 20 (12%) interventions. Sixty (77%) out of the 78 trials reported the administrative context in which interventions were delivered and 36 (46%) trials detailed the expertise of the practitioners. We conclude that bespoke reporting tools should be developed for anaesthetic interventions and interventions in other areas such as critical care.     

A systematic review of the literature reporting on randomised controlled trials comparing treatments for faecal incontinence in adults

Aim: To perform a review of the literature reporting on randomised controlled trials (RCTs) comparing treatments for faecal incontinence (FI) in adults.

Methods: A literature search of MEDLINE, Embase, Science Citation Index Expanded and Cochrane was performed in order to identify RCTs reporting on treatments for FI.

Results: The review included 60 RCTs reporting on 4838 patients with a mean age ranging from 36.8 to 88 years. From the included RCTs, 32 did not identify a significant difference between the treatments compared. Contradictory results were identified in RCTs comparing percutaneous posterior tibial nerve stimulation and transcutaneous tibial nerve stimulation versus sham stimulation, biofeedback-pelvic floor muscle training (BF-PFMT) versus PFMT, and between bulking agents such as PTQ^TM versus Durasphere^®. In two separate RCTs, combination treatment of amplitude-modulated medium frequency stimulation and electromyography-biofeedback (EMG-BF), was noted to be superior to EMG-BF and low-frequency electrical stimulation alone. Combination of non-surgical treatments such as BF with sphincteroplasty significantly improved continence scores compared to sphincteroplasty alone. Surgical treatments were associated with higher rates of serious adverse events compared to non-surgical interventions.

Conclusions: The current evidence has not identified significant differences between treatments for FI, and where differences were identified, the results were contradictory between RCTs.     

Non-response for health-related quality of life outcomes in ICU patients: A systematic review of the reporting in randomised trials

Background

Health-related quality of life (HRQoL) is frequently assessed in randomised clinical trials (RCTs) in the intensive care unit (ICU), but data are limited regarding the proportions of patients without responses or not surviving to HRQoL follow-up and the handling of this. We aimed to describe the extent and pattern of missing HRQoL data in intensive care trials and describe how these data and deaths were handled statistically.

Methods

We conducted a systematic review and meta-analysis following a published protocol. We searched PubMed, EMBASE, CINAHL and Cochrane Library for RCTs involving adult ICU patients reporting HRQoL as an outcome and excluded RCTs unobtainable in full text. We performed risk of bias assessment independently and in duplicate.

Results

We included 196 outcomes from 88 RCTs published in the years 2002–2022; the numbers of patients alive and eligible to respond HRQoL were reported in 76% of trials. At follow-up, median 27% (interquartile range 14%–39%) of patients had died, and median 20% (9%–38%) of survivors did not respond across outcomes. Analyses of 80% of outcomes were restricted to complete cases only. The handling of non-survivors in analyses were reported for 46% of outcomes, with 26% of all outcomes reported as including non-survivors (using the value zero or the worst possible score).

Conclusion

For HRQoL outcomes in ICU trials, we found that mortality at time of follow-up was high and non-response among survivors frequent. The reporting and statistical handling of these issues were insufficient, which may have biased results.     

Enrollment and reporting practices in pediatric general surgical randomized clinical trials: A systematic review and observational analysis

Background

Pediatric surgical randomized clinical trials (RCTs) are labor-intensive and costly. This systematic review investigated patient accrual and estimates of study duration in RCTs by interrogating enrollment and registration practices.

Heterogeneity in reporting on urinary outcome and cure after surgical interventions for stress urinary incontinence in adult neuro‐urological patients: A systematic review

Aims

To describe all outcome parameters and definitions of cure used to report on outcome of surgical interventions for stress urinary incontinence (SUI) in neuro‐urological (NU) patients.

Methods

This systematic review was performed and reported according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) statement. The study protocol was registered and published (CRD42016033303; http://www.crd.york.ac.uk/PROSPERO ). Medline, Embase, Cochrane controlled trials databases, and clinicaltrial.gov were systematically searched for relevant publications until February 2017.

Results

A total of 3168 abstracts were screened. Seventeen studies reporting on SUI surgeries in NU patients were included. Sixteen different outcome parameters and nine definitions of cure were used. Six studies reported on objective outcome parameters mainly derived from urodynamic investigations. All studies reported on one or more subjective outcome parameters. Patient‐reported pad use (reported during interview) was the most commonly used outcome parameter. Only three of 17 studies used standardized questionnaires (two on impact of incontinence and one on quality of life). Overall, a high risk of bias was found.

Conclusions

We found a considerable heterogeneity in outcome parameters and definitions of cure used to report on outcome of surgical interventions for SUI in NU patients. The results of this systematic review may begin the dialogue to a future consensus on this topic. Standardization of outcome parameters and definitions of cure would enable researchers and clinicians to consistently compare outcomes of different studies and therapies.     

Dilation and surgical management in vaginal agenesis: a systematic review

Introduction

The management of vaginal agenesis is currently determined by geographical location and surgeon preference. The optimal treatment is unknown and the majority of articles on technique and outcome focus on personal case series with little standardisation of reporting and follow-up.

Methods

Six thousand six hundred and ninety-one articles concerning the management of vaginal agenesis were systematically reviewed, with 162 fitting the inclusion criteria.

Results

Only one randomised control trial was included with the remaining articles made up of case series or case reports. The bowel vaginoplasty method was most commonly reported historically with 945 patients and 45 articles included. The Vecchietti procedure had the shortest operative time, but the highest number of urological injuries (2.1 %). The split thickness procedure had the highest infection rate (4.2 %) and re-operation rate (7.84 %).

Conclusion

Overall, the conservative method using dilation had the fewest complications, with an average vaginal length of 6.65 cm (± 1.39 cm). However, with an operative procedure full consent is imperative, as is an understanding of the need for postoperative dilation with the majority of techniques.     

Laparoscopic rectopexy for full-thickness rectal prolapse: a single-institution retrospective study evaluating surgical outcome

Background The laparoscopic approach promises to become the gold standard for the transabdominal management of full-thickness rectal prolapse. The aim of this study was to review our experience and to highlight the functional results achieved with this new technique.Methods Forty-eight patients with full-thickness external prolapse underwent laparoscopic repair between February 1997 and February 2003. All patients underwent preoperative evaluation of their rectal function. Patients with isolated rectal ulcer without prolapse or with internal prolapse and patients deemed by the anesthesiologist to be unfit for general anesthesia were excluded from the study. The laparoscopic technique was either a mesh rectopexy without resection (n = 35) or a suture rectopexy with sigmoid resection (n = 13). Patients with intractable constipation preceding the development of the rectal prolapse were advised to have a resection–rectopexy. In the postoperative follow-up, attention was paid to mortality, morbidity, recurrent prolapse, incontinence, and constipation. Follow-up was done by clinical review and postal questionnaire.Results There were no deaths and no septic or anastomotic complications. The postoperative morbidity rate was 5%. Oral intake was started on postoperative day 1. Discharge from the hospital was on postoperative day 4 in patients without sigmoid resection and on postoperative day 7 in patients with sigmoid resection. Two patients (4%) developed recurrent total prolapse during a median follow-up period of 36 ± 15 months (range, 7–77). The functional results were good or excellent in 72% of the cases, without digitations or dyschesia. Continence was improved in 31% of the patients and remains unchanged in 64% of them. In 11 patients (23%), constipation was worsened by the procedure.Conclusion Laparoscopic rectopexy with or without resection is both safe and effective. Advantages include low-morbidity, improved cosmesis, the rapid return of intestinal function, early discharge from hospital, and a low recurrence rate. The fecal continence score is improved; however, constipation is frequently worsened.This work is dedicated to the memory of Gerard Trebuchet, a highly influential French surgeon remembered for his implementation of several techniques for laparoscopic colon resection. Gerard Trebuchet died in Rennes, Frence, on 1 September 2003, at the age of 59 years.     

The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis

Introduction and hypothesis

The treatment of post-hysterectomy vaginal vault prolapse (VVP) has been investigated in several randomized clinical trials (RCTs), but a systematic review of the topic is still lacking. The aim of this study is to compare the effectiveness of treatments for VVP.

Methods

We performed a systematic review and meta-analysis of the literature on the treatment of VVP found in PubMed and Embase. Reference lists of identified relevant articles were checked for additional articles. A network plot was constructed to illustrate the geometry of the network of the treatments included. Only RCTs reporting on the treatment of VVP were eligible, conditional on a minimum of 30 participants with VVP and a follow-up of at least 6 months.

Results

Nine RCTs reporting 846 women (ranging from 95 to 168 women) met the inclusion criteria. All surgical techniques were associated with good subjective results, and without differences between the compared technique, with the exception of the comparison of vaginal mesh (VM) vs laparoscopic sacrocolpopexy (LSC). LSC is associated with a higher satisfaction rate. The anatomical results of the sacrocolpopexy (laparoscopic, robotic [RSC]. and abdominal [ASC]) are the best (62–91%), followed by the VM. However, the ranges of the anatomical outcome of VM were wide (43–97%). The poorest results are described for the sacrospinal fixation (SSF; 35–81%), which also correlates with the higher reoperation rate for pelvic organ prolapse (POP; 5–9%). The highest percentage of complications were reported after ASC (2–19%), VM (6–29%), and RSC (54%). Mesh exposure was seen most often after VM (8–21%). The rate of reoperations carried out because of complications, recurrence prolapse, and incontinence of VM was 13–22%. Overall, sacrocolpopexy reported the best results at follow-up, with an outlier of one trial reporting the highest reoperation rate for POP (11%). The results of the RSC are too small to make any conclusion, but LSC seems to be preferable to ASC.

Conclusions

A comparison of techniques was difficult because of heterogeneity; therefore, a network meta-analysis was not possible. All techniques have proved to be effective. The reported differences between the techniques were negligible. Therefore, a standard treatment for VVP could not be given according to this review.

     

Indirect comparison of interventions using published randomised trials: systematic review of PDE-5 inhibitors for erectile dysfunction

Background

There are no randomised and properly blinded trials directly comparing one PDE-5 inhibitor with another in a normal home setting. Valid indirect comparisons with a common comparator must examine equivalent doses, similar duration, similar populations, with the same outcomes reported in the same way.

Methods

Published randomised, double-blind trials of oral PDE-5 inhibitors for erectile dysfunction were sought from reference lists in previous reviews and electronic searching. Analyses of efficacy and harm were carried out for each treatment, and results compared where there was a common comparator and consistency of outcome reporting, using equivalent doses.

Results

Analysis was limited by differential reporting of outcomes. Sildenafil trials were clinically and geographically more diverse. Tadalafil and vardenafil trials tended to use enriched enrolment. Using all trials, the three interventions were similar for consistently reported efficacy outcomes. Rates of successful intercourse for sildenafil, tadalafil and vardenafil were 65%, 62%, and 59%, with placebo rates of 23–28%. The rates of improved erections were 76%, 75% and 71%, respectively, with placebo rates of 22–24%, and NNTs of 1.9 or 2.0. Reporting of withdrawals was less consistent, but all-cause withdrawals for sildenafil, tadalafil and vardenafil were 8% 13% and 20%. All three drugs were well tolerated, with headache being the most commonly reported event at 13–17%. There were few serious adverse events.

Conclusion

There were differences between trials in outcomes reported, limiting comparisons, and the most useful outcomes were not reported. For common outcomes there was similar efficacy between PDE-5 inhibitors.     

Short-term efficacy of physical interventions in osteoarthritic knee pain. A systematic review and meta-analysis of randomised placebo-controlled trials

Background  

Treatment efficacy of physical agents in osteoarthritis of the knee (OAK) pain has been largely unknown, and this systematic review was aimed at assessing their short-term efficacies for pain relief.     

A systematic review of outcomes in postoperative pain studies in paediatric and adolescent patients: towards development of a core outcome set

Systematic reviews of postoperative pain in children have called into question the consistency of outcomes measured by clinical triallists as well as the measurement instruments used for assessment. Core outcome set methodology may be a solution to improve standardisation. This study provides an evidence‐based foundation for the development of a core outcome set for paediatric postoperative pain studies. We searched ClinicalTrials.gov to identify relevant postoperative pain studies in children. The search yielded 300 registered trials. The following data were then extracted from each of the trials: phase of trial; study type; study design; sample size; all outcomes; whether the outcome was listed as primary, secondary, or tertiary; the measurement instrument for each reported outcome; the specific metric for each outcome; and the type of clinical procedure. Following screening, 134 studies were included in our study. Pain measurement was the most commonly reported outcome (n = 123), followed by total postoperative analgesic dosage (n = 83) and side‐effects (n = 25). Temporal trends indicated that pain assessment and unexpected events increased in use between 2000 and 2016, whereas postoperative analgesia measurement decreased. We found a lack of standardisation among outcomes and measurement instruments in paediatric postoperative pain studies. Development of a core outcome set may improve the quality of future trials and allow for more accurate study‐to‐study comparisons.     

Randomised controlled trials in plastic surgery: a systematic review of reporting quality

Background

We recently conducted a systematic review of the methodological quality of randomised controlled trials (RCTs) in plastic surgery. In accordance with convention, we are here separately reporting a systematic review of the reporting quality of the same RCTs.

Methods

MEDLINE® and the Cochrane Database of Systematic Reviews were searched by an information specialist from 1 January 2009 to 30 June 2011 for the MESH heading ‘Surgery, Plastic’. Limitations were entered for English language, human studies and randomised controlled trials. Manual searching for RCTs involving surgical techniques was performed within the results. Scoring of the eligible papers was performed against the 23-item CONSORT Statement checklist. Independent secondary scoring was then performed and discrepancies resolved through consensus.

Results

Fifty-seven papers met the inclusion criteria. The median CONSORT score was 11.5 out of 23 items (range 5.3–21.0). Items where compliance was poorest included intervention/comparator details (7 %), randomisation implementation (11 %) and blinding (26 %). Journal 2010 impact factor or number of authors did not significantly correlate with CONSORT score (Spearman rho?=?0.25 and 0.12, respectively). Only 61 % declared conflicts of interest, 75 % permission from an ethics review committee, 47 % declared sources of funding and 16 % stated a trial registry number. There was no correlation between the volume of RCTs performed in a particular country and reporting quality.

Conclusions

The reporting quality of RCTs in plastic surgery needs improvement. Better education, awareness amongst all stakeholders and hard-wiring compliance through electronic journal submission systems could be the way forward. We call for the international plastic surgical community to work together on these long-standing problems.     

Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials

The number of publications on the peri‐operative use of auricular acupuncture has rapidly increased within the last decade. The aim was to evaluate clinical evidence on the efficacy of auricular acupuncture for postoperative pain control. Electronic databases: Medline, MedPilot, DARE, Clinical Resource, Scopus and Biological Abstracts were searched from their inception to September 2007. All randomised clinical trials on the treatment of postoperative pain with auricular acupuncture were considered and their quality was evaluated using the Jadad scale. Pain intensity and analgesic requirements were defined as the primary outcome measures. Of 23 articles, nine fulfilled the inclusion criteria. Meta‐analytic approach was not possible because of the heterogeneity of the primary studies. In eight of the trials, auricular acupuncture was superior to control conditions. Seven randomised clinical trials scored three or more points on the Jadad scale but none of them reached the maximum of 5 points. The evidence that auricular acupuncture reduces postoperative pain is promising but not compelling.