Integration of clinical and patient‐reported outcomes in surgical oncology

Background:

Patient‐reported outcomes (PROs) provide information about the patient perspective and experience of undergoing surgery for cancer, but evidence suggests that they are not used widely to influence practice. This review considers key challenges and opportunities for using PROs effectively in gastrointestinal surgical oncology, drawing on principles learnt from surgical oncology in general.

Methods:

Systematic reviews of randomized controlled trials (RCTs) in surgical oncology reporting PROs as primary or secondary outcomes, and studies examining methods to communicate PRO information, were identified. Common themes are summarized and the future of PRO studies considered.

Results:

Reviews highlighted the need for improved design, conduct and reporting of PROs in RCTs in surgical oncology. Main issues related to the multiplicity of PRO measures hindering data synthesis and clinical understanding, problems with missing data risking bias, and limited integration of clinical and PRO data undermining the role of PRO data in practice. Reviews indicated that patients want PRO data to meet information needs and early work shows that graphically displayed PROs are understood by patients.

Conclusion:

PROs have a role in the evaluation of surgical oncology, but increased consensus and collaboration between surgeons and methodologists is needed to improve the design, conduct and reporting of PROs with clinical outcomes in trials. Possible solutions include investing more effort and systematic thought into the PRO rationale in RCTs, the development and use of ‘core outcome sets’ with PROs, and implementation of the extension to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting PROs in RCTs. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.     

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality

Aims

Overactive bladder (OAB) disproportionately affects older‐aged adults, yet most randomized controlled trials (RCTs) underrepresent patients ≥65. This systematic literature review (SLR) identified RCTs evaluating β‐3 adrenergic agonists or muscarinic antagonists in elderly patients with OAB, and compared study quality across trials.

Methods

MEDLINE^®, Embase^®, and Cochrane Collaboration Central Register of Clinical Trials databases were searched from inception through April 28, 2015 to identify published, peer‐reviewed RCT reports evaluating β‐3 adrenergic agonists or muscarinic antagonists in elderly OAB patients (either ≥65 years or study‐described as “elderly”). To assess study quality of RCT reports, we focused on internal/external validity, assessed via two scales: the validated Effective Public Health Practice Project [EPHPP]): Quality Assessment Tool for Quantitative Studies, and a tool commissioned by the Agency for Healthcare Research and Quality (AHRQ).

Results

Database searches yielded 1380 records that were then screened according to predefined inclusion/exclusion criteria. We included eight papers meeting study criteria. Despite scientific community efforts to improve RCT reporting standards, published reports still include incomplete and inconsistent reporting—of subject attrition, baseline patient characteristics, inclusion/exclusion criteria, and other important details. Only three of the eight OAB RCTs in this review received quality ratings of Strong (EPHPP) or Fair (AHRQ) and were multicenter with large samples.

Conclusions

Despite the prevalence of OAB among older age individuals, relatively few RCTs evaluate OAB treatments explicitly among elderly subjects. The findings from this quality assessment suggest some areas for improvement in both conduct and reporting of future RCTs assessing OAB treatment in elderly.     

Randomized controlled trials in neurosurgery—how good are we?

Summary Background  The strongest evidence in medical clinical literature is represented by randomized controlled trials (RCTs). This study was designed to evaluate neurosurgically relevant RCTs published recently by neurosurgeons. Method  A literature search in MEDLINE and EMBASE included all clinical studies published up to 30 June 2006. RCTs with neurosurgical relevance published by at least one author with affiliation to a neurosurgical department were selected. The number and characteristics of individual trials were recorded, and the quality of the trials with regard to study design, quality of reporting, and relevance for clinical practice was assessed by two different investigators using a modification of the Scottish Intercollegiate Guidelines Network methodology checklist. Changes of RCT quality over time as well as factors influencing the quality were analyzed. Findings  From the initial search results (MEDLINE n = 3,860, EMBASE n = 3,113 articles), 159 RCTs published by neurosurgeons were extracted for final evaluation. Of the RCTs, 62% have been published since 1995; 52% came from the USA, UK, and Germany. The median RCT sample size was 78 patients and the median follow-up 35.7 weeks. Fifty-two percent of all RCTs were of good, 37% of moderate, and 11% of bad quality, with an improvement over time. RCTs with financial funding and RCTs with a sample size of >78 patients were of significantly better quality. There were no major differences in the rating of the studies between the two investigators. Conclusions  Only a fraction of neurosurgically relevant literature consists of RCTs, but the quality is satisfying and has significantly improved over the last years. An adequate sample size and sufficient financial support seem to be of substantial importance with regard to the quality of the study. Our data also show that by using a standardized checklist, the quality of trials can be reliably assessed by observers of different experience and educational levels.     

Systematic review of back schools,brief education,and fear-avoidance training for chronic low back pain

BackgroundSeven previous systematic reviews (SRs) have evaluated back schools, and one has evaluated brief education, with the latest SR including studies until November 2004.The effectiveness of fear-avoidance training has not been assessed.PurposeTo assess the effectiveness of back schools, brief education, and fear-avoidance training for chronic low back pain (CLBP).Study designA SR.MethodsWe searched the MEDLINE database of randomized controlled trials (RCT) until August 2006 for relevant trials reported in English. Assessment of effectiveness was based on pain, disability, and sick leave. RCTs that reported back schools, or brief education as the main intervention, were included. For fear-avoidance training, evaluation of domain-specific outcome was required. Two reviewers independently reviewed the studies.ResultsEight RCTs including 1,002 patients evaluated back schools, three studies were of high quality. We found conflicting evidence for back schools compared with waiting list, placebo, usual care, and exercises, and a cognitive behavioral back school. Twelve trials including 3,583 patients evaluated brief education. Seven trials, six of high quality, evaluated brief education in the clinical setting. We found strong evidence of effectiveness on sick leave and short-term disability compared with usual care. We found conflicting or limited evidence for back book or Internet discussion (five trials, two of high quality) compared with waiting list, no intervention, massage, yoga, or exercises. Three RCTs of high quality, including 364 patients, evaluated fear-avoidance training. We found moderate evidence that there is no difference between rehabilitation including fear-avoidance training and spinal fusion.ConclusionsConsistent recommendations are given for brief education in the clinical setting, and fear-avoidance training should be considered as an alternative to spinal fusion, and back schools may be considered in the occupational setting. The discordance between reviews can be attributed differences in inclusion criteria and application of evidence rules.     

Assurance of surgical quality within multicenter randomized controlled trials for bariatric and metabolic surgery: a systematic review

BackgroundSurgical quality assurance methods aim to ensure standardization and high quality of surgical techniques within multicenter randomized controlled trials (RCTs), thereby diminishing the heterogeneity of surgery and reducing biases due to surgical variation. This study aimed to establish the measures undertaken to ensure surgical quality within multicenter RCTs investigating bariatric and metabolic surgery, and their influence upon clinical outcomes.MethodsAn electronic literature search was performed from the Embase, Medline, and Web of Science databases to identify multicenter RCTs investigating bariatric and metabolic surgery. Each RCT was evaluated against a checklist of surgical quality measures within 3 domain: (1) standardization of surgical techniques; (2) credentialing of surgical experience; and (3) monitoring of performance. Outcome measures were postoperative weight change and complications.ResultsNineteen multicenter RCTs were included in the analysis. Three studies undertook pretrial education of surgical standard. Fourteen studies described complete standardization of surgical techniques. Four studies credentialed surgeons by case volume prior to enrollment. Two studies used intraoperative or video evaluation of surgical technique prior to enrollment. Only two studies monitored performance during the study. Although there were limited quality assurance methods undertaken, utilization of these techniques was associated with reduced overall complications. Standardization of surgery was associated with reduced re-operation rates but did not influence postoperative weight loss.ConclusionThe utilization of methods for surgical quality assurance are very limited within multicenter RCTs of bariatric and metabolic surgery. Future studies must implement surgical quality assurance methods to reduce variability of surgical performance and potential bias within RCTs.     

Evaluation of spin in the abstracts of orthopedic trauma literature: A cross-sectional review

ObjectivesA cross-sectional analysis of orthopedic trauma randomized controlled trial (RCT) abstracts to assess the frequency and manifestations of spin, the misrepresentation or distortion of research findings, in orthopedic trauma clinical trials.MethodsThe top 5 orthopedic trauma journals were searched from January 1, 2012, to December 31, 2017. RCTs with nonsignificant endpoints (p > .05) were analyzed for spin in the abstract. The primary endpoint of our investigation was the frequency and type of spin. The secondary endpoint was to assess whether funding source was associated with the presence of spin. Due to the low reporting of funding sources no statistics were able to be computed for this outcome.ResultsOur PubMed search yielded 517 articles. Primary screening excluded 303 articles, and full text evaluation excluded an additional 161. Overall, 53 articles were included. Spin was identified in 35 of the 53 (66.0%) abstracts analyzed. Evidence of spin was found in 21 (39.6%) abstract results sections and 22 (41.5%) abstract conclusion sections. Of the 21 RCTs reporting a clinical trial registry, 3 (14.3%) had evidence of selective reporting bias.ConclusionsOrthopedic trauma RCTs from highly ranked journals with nonsignificant endpoints published from 2012 to 2017 frequently have spin in their abstracts. Abstracts with evidence of spin may influence a reader's perception of new drugs or procedures. In orthopedic trauma, the implications of spin may affect the treatment of patients with orthopedic trauma, so efforts to mitigate spin in RCT abstracts must be prioritized.     

Feasibility and delivery of patient-reported outcomes in clinical practice among racially diverse bladder and prostate cancer patients

ObjectiveTo assess the feasibility of enrollment and collecting patient-reported outcome (PRO) data as part of routine clinical urologic care for bladder and prostate cancer patients and examine overall patterns and racial variations in PRO use and symptom reports over time.Subjects/Patients and MethodsWe recruited 76 patients (n = 29 Black and n = 47 White) with prostate or bladder cancer at a single, comprehensive cancer center. The majority of prostate cancer patients had intermediate risk (57%) disease and underwent either radiation or prostatectomy. Over half (58%) of bladder cancer patients had muscle invasive disease and underwent cystectomy.Patients were asked to complete PRO symptom surveys using their preferred mode [web- or phone-based interactive voice response (IVR)]. Symptom summary reports were shared with providers during visits. Surveys were completed at 3 time points and assessed urinary, sexual, gastrointestinal, anxiety/depression, and sleep symptoms. Feasibility of enrollment and survey completion were calculated, and linear mixed effects models estimated differences in outcomes by race and time.ResultsSixty three percent of study participants completed all PRO measures at all 3 time points. Black patients were more likely to select IVR as their survey mode (40% vs. 13%, P < 0.05), and less likely to complete all surveys (55% vs. 74%, P = 0.13). Patients using IVR were also less likely to complete all surveys (41% vs. 69%, P = 0.046).ConclusionsReported preferences for survey mode and completion rates differ by race, which may influence survey completion rates and highlight potential obstacles for equitable implementation of PROs into clinical care.     

Methodological and Ethical Quality of Randomized Controlled Clinical Trials in Gastrointestinal Surgery

Background

The randomized controlled trial (RCT) is the gold standard tool used to evaluate therapeutic interventions. Methodological and ethical aspects should be adequately reported to enable readers to make informed and justified judgments regarding the validity of a trial and the treatment effectiveness.

Objective

The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in gastrointestinal surgery and to assess the relationship between these two qualities.

Study Design

All of the articles chosen for review reported on phase III randomized controlled gastrointestinal surgical trials were published in 12 international journals during 2006 and 2007. The eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. The methodological quality was evaluated using the Jadad scale, and the ethical quality was evaluated using the Berdeu score.

Results

The mean Jadad score was 9.7?±?1.78. The methodological quality was insufficient in 64 RCTs (37.4?%; Jadad score <9). The mean Berdeu score was 0.36?±?0.08. The journal impact factor, number of randomized patients, and number of centers correlated with the outcome of the Jadad score, and the journal impact factor, industry funding, and year in which the trial began correlated with the outcome of the Berdeu score. Informed consent from patients was not obtained in 7?% (n?=?12) of the RCTs, and research ethics committee approval was not mentioned in 14.6?% (n?=?25) of the RCTs.

Conclusions

The reporting of gastrointestinal surgery RCTs is less than optimal. In our study, the trials of higher methodological quality were more likely to provide information about their ethical aspects. These results suggest the need for more attention to be paid to the conduct of clinical research and the reporting of ethical aspects. The appropriation of the ethical rules by surgeons involved in human clinical trials could improve the methodology and reporting of RCTs in gastrointestinal surgery.     

Race,ethnicity, and gender reporting in North American clinical trials for BCG-unresponsive non-muscle invasive bladder cancer

IntroductionThe National Institutes of Health (NIH) Revitalization Act of 1993 established guidelines for the inclusion of racial/ethnic minorities and women in clinical research. However, the reporting rate of such patient demographic data in clinical trials for BCG-unresponsive non-muscle invasive bladder cancer is not well characterized.MethodsWe identified published clinical trials of all phases (I –III) for BCG-unresponsive non-muscle invasive bladder cancer conducted in the US and/or Canada. We calculated the proportion of studies reporting patient gender and race/ethnicity, tabulating these data when present. We compared reported trial participant race, ethnicity and gender with the number of new bladder cancer cases and deaths using the Centers for Disease Control and Prevention (CDC) and National Cancer Institute (NCI) U.S. Cancer Statistics data from 2013 –2017.ResultsWe identified 27 trials published from 1998 –2021 enrolling a total of 1673 patients. While all trials included data on patient gender (22% women overall), only 40.7% included any data on patient race/ethnicity. Among those that did, trial participants were reported as white (94%), Black (2.1%), Hispanic (0.6%), Asian (0.9%), and Other (2.3%). Racial/ethnic minorities were underrepresented in clinical trials relative to their proportion of new bladder cancer cases and deaths.ConclusionMost clinical trials that have been conducted for BCG-unresponsive non-muscle invasive bladder cancer do not report data on patient race or ethnicity despite NIH guidelines advocating for inclusion of such data. Racial/ethnic minorities remain underrepresented in these trials relative to the burden of bladder cancer prevalence and mortality faced by these groups.     

Reporting results in manual therapy clinical trials: A need for improvement

BackgroundThe number of randomized clinical trials (RCTs) for manual therapy (MT) has increased exponentially in recent years but the quality of reporting is heterogeneous.ObjectiveTo assess the quality of the reporting of results in RCTs manual therapy, both in the text and in the graphs.Study designMethodological review.MethodsWe reviewed a random sample of 120 RCTs in MT published between 2000 and 2020 in indexed journals. We identified the primary outcome for each trial, and evaluated the completeness and correctness of reporting of results in the text and in the graphs.ResultsForty per cent of the RCTs explicitly identified the primary outcome and 47.5% reported a sample size calculation. In 46.7% of the trials, the reporting of between groups comparisons was complete (including effect size and precision). Only 29.2% used the confidence interval as a measure of precision. Fifty-eight per cent of the trials reported significant differences in the results, and 30.8% reported a value of clinical relevance for at least one variable of the study. Forty-seven per cent reported the primary outcome graphically but only 19.6% of the graphs were self explanatory and 66.1% had problems of visual clarity.ConclusionsOur findings suggest that the reporting of the results in MT trials is generally incomplete and graphics are often poor. These shortcomings could affect the interpretation of the results and their application in clinical practice. Improvements are needed in the reporting of results in order to advance clinical practice and research in manual therapy.     

Characterization and Potential Relevance of Randomized Controlled Trial Patient Populations in Total Joint Arthroplasty in the United States: A Systematic Review

BackgroundA substantial number of randomized controlled trial (RCT) studies in total joint arthroplasty (TJA) are published each year in the United States (US). However, it is unknown how closely the demographic and clinical characteristics of these cohorts resemble that of the US patient population undergoing TJA. Thus, the purpose of this systematic review was to evaluate the patient characteristics of published RCTs in TJA in the US and to compare these characteristics against patient cohorts from national patient databases.MethodsRCT studies regarding primary TJA conducted in the US were selected. Key patient demographics were aggregated and compared against demographics characteristics of the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality National Inpatient Sample (NIS) and American College of Surgeons National Surgical Quality Improvement Program patient cohorts.ResultsOne hundred and fifty-three RCTs fulfilled the inclusion criteria and were included. The total number of patients in the 153 RCTs was 24,135 patients. The average age of patients in the TJA RCT cohort was 65 years (53-80) while the NIS cohort was 67 years (18-90) (d = 0.21, effect size = small). The average body mass index of the TJA RCT cohort was 30.8 (18.2-37.6) while the National Surgical Quality Improvement Program cohort was 31.9 (14.1-59.6) (d = 0.18, effect size = small). For TJA, effect sizes for age, body mass index BMI, sex, ethnicity, smoking, and diabetes were all small or very small.ConclusionOverall, the US RCT patient cohort for TJA does not differ substantially from the general patient population undergoing TJA in the United States. Differences in demographic and clinical characteristics between the TJA RCT cohort and database cohorts ranged from minimal to small, suggesting that these differences are unlikely to impact clinical outcomes.     

Pelvic radiotherapy and sexual function in women

Background

During the past decade there has been considerable progress in developing new radiation methods for cancer treatment. Pelvic radiotherapy constitutes the primary or (neo) adjuvant treatment of many pelvic cancers e.g., locally advanced cervical and rectal cancer. There is an increasing focus on late effects and an increasing awareness that patient reported outcomes (PROs) i.e., patient assessment of physical, social, psychological, and sexual functioning provides the most valid information on the effects of cancer treatment. Following cure of cancer allow survivors focus on quality of life (QOL) issues; sexual functioning has proved to be one of the most important aspects of concern in long-term survivors.

Methods

An updated literature search in PubMed was performed on pelvic radiotherapy and female sexual functioning/dysfunction. Studies on gynaecological, urological and gastrointestinal cancers were included. The focus was on the period from 2010 to 2014, on studies using PROs, on potential randomized controlled trials (RCTs) where female sexual dysfunction (FSD) at least constituted a secondary outcome, and on studies reporting from modern radiotherapy modalities.

Results

The literature search revealed a few RCTs with FSD evaluated as a PRO and being a secondary outcome measure in endometrial and in rectal cancer patients. Very limited information could be extracted regarding FSD in bladder, vulva, and anal cancer patients. The literature before and after 2010 confirms that pelvic radiotherapy, independent on modality, increases the risk significantly for FSD both compared to data from age-matched healthy control women and compared to data on patients treated by surgery only. There was only very limited data available on modern radiotherapy modalities. These are awaited during the next five years. Several newer studies confirm that health care professionals are still reluctant to discuss treatment induced sexual dysfunction with patients.

Conclusions

Pelvic radiotherapy has a persistent deteriorating effect on the vaginal mucosa impacting negatively on the sexual functioning in female cancer patients. Hopefully, modern radiotherapy modalities will cause less vaginal morbidity but results are awaited to confirm this assumption. Health care professionals are encouraged to address potential sexual dysfunction both before and after radiotherapy and to focus more on quality than on quantity.     

Methodological quality of randomised controlled trials in burns care. A systematic review

Objective

To evaluate the methodological quality of published randomised controlled trials (RCTs) in burn care treatment and management.

Methods

Using a predetermined search strategy we searched Ovid MEDLINE (1950 to January 2008) database to identify all English RCTs related to burn care. Full text studies identified were reviewed for key demographic and methodological characteristics. Methodological trial quality was assessed using the Jadad scale.

Results

A total of 257 studies involving 14,535 patients met the inclusion criteria. The median Jadad score was 2 (out of a best possible score of 5). Information was given in the introduction and discussion sections of most RCTs, although insufficient detail was provided on randomisation, allocation concealment, and blinding. The number of RCTs increased between 1950 and 2008 (Spearman's rho = 0.6129, P < 0.001), although the reporting quality did not improve over the same time period (P = 0.1896) and was better in RCTs with larger sample sizes (median Jadad score, 4 vs. 2 points, P < 0.0001). Methodological quality did not correlate with journal impact factor (P = 0.2371).

Conclusions

The reporting standards of RCTs are highly variable and less than optimal in most cases. The advent of evidence-based medicine heralds a new approach to burns care and systematic steps are needed to improve the quality of RCTs in this field. Identifying and reviewing the existing number of RCTs not only highlights the need for burn clinicians to conduct more trials, but may also encourage burn health clinicians to consider the importance of conducting trials that follow appropriate, evidence-based standards.     

Immune checkpoints inhibitors in the management of high-risk non-muscle-invasive bladder cancer. A scoping review

PurposeProvide the current state of trials investigating the effectiveness and safety of checkpoint inhibitors in patients with non-muscle invasive bladder cancer.MethodsWe conducted this scoping review following the recommendations of the Joanna Briggs Institute. We searched for MEDLINE, EMBASE, CENTRAL databases, and clinical trials in search engines such as clinicaltrials.gov and clinicaltrialsregister.eu. We included clinical trials in patients over 18 years of age diagnosed with high-risk non-muscle-invasive bladder cancer who suffer treatment failure with Bacillus Calmette-Guérin (BCG). Even those who have not received prior therapy. Those clinical trials also evaluated intravenous- or intravesical-administered immune checkpoint inhibitors and those associated with BCG.ResultsThirteen clinical trials are currently being developed with immune checkpoint inhibitors as a therapeutic alternative in patients diagnosed with non-muscle-invasive urothelial carcinoma of the bladder. Five of these have not received prior therapy with bacillus Calmette-Guérin. The remaining eight studies in patients who received BCG immunotherapy with a poor response are classified as persistent, refractory, or non-responders to BCG therapy. Also, in patients who do not accept surgical management with radical cystectomy. Preliminary results from studies such as SWOG S1605 (NCT02844816) show encouraging antitumor activity and long-lasting response patients with carcinoma in situ with or without papillary disease in terms of disease-free survival and rate free of adverse events. Recently, Keynote-057 (NCT02625961) evidenced that after 36 months of follow-up, Pembrolizumab as monotherapy was tolerable and showed promising antitumor activity in patients with BCG-unresponsive non-muscle-invasive bladder cancer.ConclusionThe checkpoint inhibitor response may offer a therapeutic alternative for patients diagnosed with high-risk non-muscle-invasive bladder cancer. However, the complete response rate documented in this scoping review is limited to patients with carcinoma in situ, with mild adverse effects, without reporting severity or death from the intervention.     

Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge

Background contextAfter decades of clinical research, the role of surgery for chronic nonspecific low back pain (CNLBP) remains equivocal. Despite significant intellectual, human, and economic investments into randomized controlled trials (RCTs) in the past two decades, the role of surgery in the treatment for CNLBP has not been clarified.PurposeTo delineate the historical research agenda of surgical RCTs for CNLBP performed between 1993 and 2012 investigating whether conclusions from earlier published trials influenced the choice of research questions of subsequent RCTs on elucidating the role of surgery in the management of CNLBP.Study designLiterature review.MethodsWe searched the literature for all RCTs involving surgery for CNLBP. We reviewed relevant studies to identify the study question, comparator arms, and sample size. Randomized controlled trials were classified as “indication” trials if they evaluated the effectiveness of surgical therapy versus nonoperative care or as “technical” if they compared different surgical techniques, adjuncts, or procedures. We used citation analysis to determine the impact of trials on subsequent research in the field.ResultsAltogether 33 technical RCTs (3,790 patients) and 6 indication RCTs (981 patients) have been performed. Since 2007, despite the unclear benefits of surgery reported by the first four indication trials published in 2001 to 2006, technical trials have continued to predominate (16 vs. 2). Of the technical trials, types of instrumentation (13 trials, 1,332 patients), bone graft materials and substitutes (11 trials, 833 patients), and disc arthroplasty versus fusion (5 trials, 1,337 patients) were the most common comparisons made. Surgeon authors have predominantly cited one of the indication trials that reported more favorable results for surgery, despite a lack of superior methodology or sample size. Trials evaluating bone morphogenic protein, instrumentation, and disc arthroplasty were all cited more frequently than the largest trial of surgical versus nonsurgical therapy.ConclusionsThe research agenda of RCTs for surgery of CNLBP has not changed substantially in the last 20 years. Technical trials evaluating nuances of surgical techniques significantly predominate. Despite the publication of four RCTs reporting equivocal benefits of surgery for CNLBP between 2001 and 2006, there was no change in the research agenda of subsequent RCTs, and technical trials continued to outnumber indication trials. Rather than clarifying what, if any, indications for surgery exist, investigators in the field continue to analyze variations in surgical technique, which will probably have relatively little impact on patient outcomes. As a result, clinicians unfortunately have little evidence to advise patients regarding surgical intervention for CNLBP.     

Challenging issues in randomised controlled trials

What this topic is aboutRandomised controlled trials (RCTs) are the most rigorous way of determining whether a cause–effect relation exists between treatment and outcome and are an integral component in the hierarchy of evidence which guide current clinical practice. Whether ensuring the success of a RCT or interpreting the medical literature, it is important to understand the key components of RCT design to assess their quality and therefore the weight which should be attributed to its findings. This article will highlight some of these key components by using a number of ongoing trauma studies being co-ordinated by the Australian and New Zealand Intensive Care Research Centre, Monash University.Common problems and challengesThe quality of many RCTs could be improved by avoiding some common pitfalls, such as (i) unclear hypotheses and multiple objectives, (ii) poor selection of endpoints, (iii) inappropriate subject selection criteria, (iv) non-clinically relevant or feasible treatment/intervention regimens, (v) inadequate randomisation, stratification, blinding, (vi) lack of stratification in small RCTs (vii) inadequate blinding of trials, (viii) insufficient sample size/power, (ix) failure to use intention to treat analysis and (x) failure to anticipate common practical problems encountered during the conduct of a RCT.Tips for researchersThe RCTs most likely to be funded and/or be of high quality always address these issues.     

Examination of Randomized Trials and Corresponding Trial Registry Entries: Registration Timing and Primary Outcome Analysis in the Journal of Arthroplasty

BackgroundProspective trial registration enhances transparency and rigor of trial reporting. We conducted an in-depth examination of randomized clinical trials (RCTs) published in The Journal of Arthroplasty (JOA) from 2010 to 2020 and their associated trial registries.MethodsWe examined all RCTs published in the JOA during the even years between 2010 and 2020. We determined the proportion of trials that were registered and prospectively registered as well as the extent of consistency between primary outcome characteristics in the trials vs the registries. Trial characteristics published between 2010 and 2014 were compared to trials published between 2016 and 2020.ResultsA total of 57 (33.7%) of 169 primary RCTs over the study period reported being registered and of these, 20 (11.8%) were prospectively registered. For the registered primary RCTs, 75% reported primary outcome findings that were inconsistent with the corresponding registry. Trial registration proportion substantially improved from 13.6% between 2010 and 2014 to 53% between 2016 and 2020 (z-test = ?5.315, P < .001).ConclusionHigh proportions of retrospectively registered or unregistered trials and a very high proportion of inconsistencies in reporting of primary outcomes compared to the trial registries were found. These data argue for a well-developed strategy by JOA to enhance editorial policies, reviewer and editorial board member training and oversight, and improved arthroplasty researcher awareness to improve the current state of RCT reporting in JOA.