Carol M. Ashton

Do Surgical Trials Meet the Scientific Standards for Clinical Trials

Unlike medications, the dissemination of surgical procedures into practice is not regulated. Before marketing, pharmaceutical products are required to be shown safe and efficacious in comparative clinical trials which utilize bias-reducing strategies designed to reduce the distortion of estimates of treatment effect by predispositions towards the investigational intervention or control. Unless an investigational device is involved, the corresponding process for surgical innovations is usually unregulated and therefore may not be based upon adequate evidence. Given these differences, we sought to evaluate the state of clinical research on invasive procedures. n nWe conducted a systematic review of publications from 1999–2008 that reported the results of studies evaluating the effects of invasive therapeutic procedures, focusing on trials which appeared to influence practice. Our objective was to determine what proportion of studies evaluating surgical procedures use a comparative clinical trial design and methods to control bias. This paper reports our results and raises concerns about the methodological, and therefore the ethical, quality of clinical research used to justify the implementation of surgical procedures into practice.

Surgeon-Specific Performance Reports in General Surgery: An Observational Study of Initial Implementation and Adoption

BACKGROUNDnAs national quality initiatives are increasing requirements for individual physician data, our department of surgery initiated a surgeon-specific reporting (SSR) program to assess the value of personal knowledge on individual performance quality. We sought to evaluate the use of SSR as a tool to enable surgeons to assess and improve their clinical performance, and to identify barriers to use of their reports.nnnSTUDY DESIGNnQualitative research design involving semistructured interviews of surgeons who received performance reports derived from National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), and the Centers for Medicare and Medicaid Services (CMS) core measures and hospital administrative data. Transcripts were analyzed by the constant comparative method.nnnRESULTSnTwenty-four of 39 surgeons (61.5%) who received their SSRs agreed to be interviewed and 23 were interviewed. About half (11 of 23) demonstrated comprehension of the data validity, accuracy, or complexity. Of these, 6 took steps to validate data or improve performance. Most respondents believed SSR would lead to performance improvement through knowledge of personal outcomes and peer comparison; however, they perceived SSR had limitations, such as small sample size and potential coding errors, and could lead to unintended consequences, such as inaccurate interpretation by others and surgeons aversion to selecting high-risk patients. Respondents also suggested logistical improvements to reporting methods, such as report format and definitions of metrics.nnnCONCLUSIONSnSurgeon-specific reporting has the potential to empower surgeons to improve their practice; however, more surgeons need efficient guidelines to understand the metrics. Our findings can be used to guide development of more SSR programs. Whether SSR programs lead to improvements in surgical outcomes is a matter for future research.

A stories-based interactive DVD intended to help people with hypertension achieve blood pressure control through improved communication with their doctors

OBJECTIVEnOur goal was to develop an interactive DVD to help African American and Caucasian American adults with hypertension learn how to become better communicators during medical interactions. Material was to be presented in several formats, including patients narratives (stories).nnnMETHODSnTo develop the narratives we recruited members of the target audience and elicited stories and story units in focus groups, interviews, and seminars. Story units were ranked-ordered based on conformance with the theory of planned behavior and narrative qualities and then melded into cohesive stories. The stories were recounted by actors on the DVD.nnnRESULTSn55 adults (84% women; 93% African American) participated in a focus group, interview, or seminar; transcripts yielded 120 story units. The most highly rated units were woven into 11 stories. The six highest rated stories/actor-storytellers were selected for presentation on the DVD.nnnCONCLUSIONnWe achieved our goal of developing an easy-to-use, story-driven product that may teach adults how to talk effectively with their doctors about hypertension. The DVDs effectiveness should be tested in a randomized trial.nnnPRACTICE IMPLICATIONSnBehavioral interventions aimed at improving patients ability to communicate during doctor visits may be useful adjuncts in the achievement of BP goals.

Surgeon-Specific Reports in General Surgery: Establishing Benchmarks for Peer Comparison Within a Single Hospital.

BACKGROUNDnMethods to assess a surgeons individual performance based on clinically meaningful outcomes have not been fully developed, due to small numbers of adverse outcomes and wide variation in case volumes. The Achievable Benchmark of Care (ABC) method addresses these issues by identifying benchmark-setting surgeons with high levels of performance and greater case volumes. This method was used to help surgeons compare their surgical practice to that of their peers by using merged National Surgical Quality Improvement Program (NSQIP) and Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) data to generate surgeon-specific reports.nnnSTUDY DESIGNnA retrospective cohort study at a single institutions department of surgery was conducted involving 107 surgeons (8,660 cases) over 5.5 years. Stratification of more than 32,000 CPT codes into 16 CPT clusters served as the risk adjustment. Thirty-day outcomes of interest included surgical site infection (SSI), acute kidney injury (AKI), and mortality. Performance characteristics of the ABC method were explored by examining how many surgeons were identified as benchmark-setters in view of volume and outcome rates within CPT clusters.nnnRESULTSnFor the data captured, most surgeons performed cases spanning a median of 5 CPT clusters (range 1 to 15 clusters), with a median of 26 cases (range 1 to 776 cases) and a median of 2.8 years (range 0 to 5.5 years). The highest volume surgeon for that CPT cluster set the benchmark for 6 of 16 CPT clusters for SSIs, 8 of 16 CPT clusters for AKIs, and 9 of 16 CPT clusters for mortality.nnnCONCLUSIONSnThe ABC method appears to be a sound and useful approach to identifying benchmark-setting surgeons within a single institution. Such surgeons may be able to help their peers improve their performance.

Optimizing Evaluation of Patients with Low-to-Intermediate-Risk Acute Chest Pain: A Randomized Study Comparing Stress Myocardial Perfusion Tomography Incorporating Stress-Only Imaging Versus Cardiac CT

The purpose of this study was to determine whether stress myocardial perfusion (SPECT) optimized with stress-only (SO) imaging is comparable to cardiac CT angiography (CTA) for evaluating patients with acute chest pain (ACP). Methods: This was a prospective randomized observational study in 598 ACP patients who underwent CTA versus SPECT. The primary endpoint was length of hospital stay, and secondary endpoints were test feasibility, time to diagnosis, diagnostic accuracy, radiation exposure, and overall cost. Median follow-up was 6.5 mo, with a 3.8% cardiac event rate defined as death or an acute coronary syndrome. Results: Of 2,994 patients screened, 1,703 (56.9%) were not candidates for CTA because of prior cardiac disease (41%) or imaging contraindications (16%). Time to diagnosis (8.1 ± 8.5 vs. 9.4 ± 7.4 h) and length of hospital stay (19.7 ± 27.8 vs. 23.5 ± 34.4 h) were significantly shorter with CTA than with SPECT (P = 0.002). However, time to diagnosis (7.0 ± 6.2 vs. 6.8 ± 5.9 h, P = 0.20), length of stay (15.5 ± 17.2 vs. 16.7 ± 15.3 h, P = 0.36), and hospital costs (

Systematic review of observational studies reveals no association between low back pain and lumbar spondylolysis with or without isthmic spondylolisthesis

4,242 ±

Are Surgical Trials with Negative Results Being Interpreted Correctly

3,871 vs.

A patient self-assessment tool to measure communication behaviors during doctor visits about hypertension

4,364 ± 1781, P = 0.86) were comparable with CTA versus SO SPECT, respectively. SO was also superior to conventional SPECT regarding all of the above metrics and significantly reduced radiation exposure (5.5 ± 4.4 vs. 12.5 ± 2.7 mSv, P < 0.0001). Conclusion: Stress SPECT when optimized with SO imaging is similar to CTA in time to diagnosis, length of hospital stay, and cost, with improved prognostic accuracy and less radiation exposure. Our results emphasize the importance of SO imaging, particularly in low-intermediate-risk emergency room patients who are a population likely to have a normal test result.

Optimizing Evaluation of Patients with Low to Intermediate Risk Acute Chest Pain: A Randomized Study Comparing Stress Myocardial Perfusion Tomography Incorporating Stress-only Imaging to Cardiac Computed Tomography

PurposeThe hypothesis that spondylolysis (SL) and/or isthmic spondylolisthesis (IS) cause low back pain (LBP) is widely accepted representing surgical indication in symptomatic cases. If SL/IS cause LBP, individuals with these conditions should be more prone to LBP than those without SL/IS. Therefore, the goal of the study was to assess whether the published primary data demonstrate an association between SL/IS and LBP in the general adult population.MethodsSystematic review of published observational studies to identify any association between SL/IS and LBP in adults. The methodological quality of the cohort and case–control studies was evaluated using the Newcastle-Ottawa scale.ResultsFifteen studies met inclusion criteria (one cohort, seven case–control, seven cross-sectional). Neither the cohort study nor the two highest-quality case–control studies detected an association between SL/IS and LBP; the same is true for the remaining studies.ConclusionsThere is no strong or consistent association between SL/IS and LBP in epidemiological studies of the general adult population that would support a hypothesis of causation. It is possible that SL/IS coexist with LBP, and observed effects of surgery and other treatment modalities are primarily due to benign natural history and nonspecific treatment effects. We conclude that traditional surgical practice for the adult general population, in which SL/IS is assumed to be the cause of non-radicular LBP whenever the two coexist, should be reconsidered in light of epidemiological data accumulated in recent decades.

The Role of the USA Food and Drug Administration in Clinical Research

BACKGROUNDnMany published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings.nnnSTUDY DESIGNnWe examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies.nnnRESULTSnThree of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year.nnnCONCLUSIONSnNegative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.