Outcomes research in pediatric surgery. Part 1: overview and resources

Outcomes research in pediatric surgery can be defined as the analysis of pediatric surgical outcomes and their predictors at different levels in the health care delivery system. The objectives of this article are to understand the differences between outcomes research and clinical trials as well as to gain familiarity with public multispecialty and specialty-specific databases. The utility of outcomes research extends to benchmarking the quality of care, refinement of management strategies, patient education, and marketing. Assessment of the integration of a new surgical technique into the health care system is best determined by examining a population-based registry, whereas comparative efficacy of surgical procedures is best assessed by randomized clinical trials. In the first part of this 2-part series, an overview and brief outline of available resources for outcomes research in pediatric surgery are reviewed. In part 2, a template is presented on how to structure and design an outcomes research question.     

Outcomes research in pediatric surgery. Part 2: how to structure a research question

Innovative treatments and procedures are essential to the advancement of surgery. Outcomes research provides the mechanism to analyze these new treatments as they enter clinical practice and evaluate them against established therapies. Information gained through this methodology is essential because new techniques and innovations often gain rapid acceptance before clinical trials can be conducted to assess them. Increasing national emphasis is placed on comparative effectiveness as health care costs rise. Surgeons must take the lead in surgical outcomes and comparative effectiveness research, with the goal of identifying the most efficient and effective treatment for our patients. The authors show how to structure and design a research project involving pediatric surgical outcomes. The model consists of the following 3 phases: (1) study design, (2) data preparation, and (3) data analysis. The model we present provides the reader with a basic format and research structure to serve as a guide to performing high-quality surgical outcomes research.     

The utility of routine trauma laboratories in pediatric trauma resuscitations

BACKGROUND: Because of the difficulties in evaluating injured children, screening blood tests are recommended. METHODS: Resuscitation blood tests (complete blood count, chem12, coagulation panel, urinalysis) were reviewed for abnormality frequency, injury correlation, managements, and outcome. RESULTS: Panels were obtained on 240 children (age < 16 years) meeting trauma system criteria. Abnormalities were identified as follows: white blood cell/hematocrit/platelets (41%, 27%, 1%), Na/K/Cl/CO(2) (3%, 30%, 23%, 14%), blood ureal nitrogen/creatinine (6%, 0%), prothrombin time/international normalized ratio/partial thromboplastin time (22%, 16%, 6%), aspartate aminotransferase/alanine transferase (43%, 35%), amylase (2%), glucose (77%), and urinalysis (31%). Organ-specific chemistries predicted injury poorly. Transaminasemia correlated with liver injury when levels exceeded 400 U/L. Two children (1%) with hyperamylasemia had abdominal injuries. Coagulation abnormalities correlated with intracranial injury (43%) and Glasgow Coma Scale (GCS 3 to 8; 56%, GCS 9 to 14; 20%, GCS 15; 14%, P <0.05). Only 25 (10%) had interventions for test abnormalities (11 transfusions, 8 fresh frozen plasma, 3 tests repeated, 3 KCl). CONCLUSIONS: Routine laboratory panels are little value in the management of injured children.     

Recent trends in National Institutes of Health funding for surgery: 2003 to 2013

Background

The purpose of this study is to compare the compositions of federally funded surgical research between 2003 and 2013, and to assess differences in funding trends between surgery and other medical specialties.

Data Sources

The National Institutes of Health (NIH) Research Portfolio Online Reporting Tool database was queried for grants within core surgical disciplines during 2003 and 2013. Funding was categorized by award type, methodology, and discipline. Application success rates for surgery and 5 nonsurgical departments were trended over time.

Conclusions

Inflation-adjusted NIH funding for surgical research decreased 19% from $270M in 2003 to $219M in 2013, with a shift from R-awards to U-awards. Proportional funding to outcomes research almost tripled, while translational research diminished. Nonsurgical departments have increased NIH application volume over the last 10 years; however, surgery’s application volume has been stagnant. To preserve surgery’s role in innovative research, new efforts are needed to incentivize an increase in application volume.     

Gender matters in renal research: a National Institutes of Health perspective

The National Institutes of Health (NIH) currently anticipates a period of growth in budgets, making renal community input into research planning and prioritizing particularly important. In considering which women's health issues should be given high priority for research study, the questions of both public health impact and scientific opportunity should be considered. A series of health topics in which there is some evidence for particular impact on women's health are briefly reviewed, and the process the NIH uses for community input and priority setting are discussed.     

Research interests and funding of members of the American Pediatric Surgical Association: report from 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee

Objective

There is lack of data relating to the research interests and funding of pediatric surgeons within the United States and Canada. These data may be helpful in promoting basic and clinical research among pediatric surgeons.

Methods

The American Pediatric Surgical Association (APSA) Outcomes and Clinical Trials Committee developed and administered an online survey via e-mail to the APSA membership to help characterize research activities and funding. The survey was available for completion during December of 2009. The survey contained 10 items with a drop-down menu for multiple choice answers and required 5 to 10 minutes to complete. Results based on research interests as well as funding sources were compiled and analyzed.

Results

A total of 275 members, which comprises 27.4% of the APSA membership, completed the survey. Of the respondents, 177 (64%) described being in an academic practice, 44 (16%) in an academically associated private practice, 9 (3.3%) in a private solo practice, 17 (6.2%) in private group practice, and 3 (1%) in the military. A total of 189 (68.7%) respondents stated that they participated in formal research. Respondents also categorized their research interests, and the following were the most common subjects of study (decreasing order of frequency): appendicitis, trauma and critical care, outcomes, minimally invasive surgery, and congenital diaphragmatic hernia. Of those participating in research, 64.5% stated that they have no formal financial support. Of those supported through the National Institutes of Health, funding grants achieved were as follows: R01 (n = 29), K08 (n = 9), K23 (n = 2), and U01 (n = 8).

Conclusions

Research activities are common among APSA members and encompass a wide range of pediatric surgery topics. Strikingly, the overall financial support of these efforts is limited, predominantly supported by the surgeons themselves. Funded respondents attained grants through Public Health Service grants, departmental grants, or private institutions.     

Single-incision laparoscopic surgery: feasibility for pediatric appendectomies

Introduction

Single-incision laparoscopic surgery (SILS) is a novel area of minimally invasive surgery using a single incision. The end result is a lone incision at the umbilicus for a perceived scarless abdomen. We report our early experience using the SILS technique for appendectomies in the pediatric population.

Methods

A retrospective chart review was performed on our first patients to undergo SILS appendectomy (SILS-A) or laparoscopic appendectomy (LAP-A) during the same period at a freestanding children's hospital.

Results

Thirty-nine patients were reviewed. Nineteen patients underwent SILS-A (8.7 ± 0.76 [SEM] years old), and 20 patients underwent LAP-A (10.5 ± 0.87 years old, 2-17). Ages were 19 months to 14 years in the SILS-A group, with 21% (4 patients) not older than 6 years. Median weight for SILS-A was 32 kg (14.5-80.3). Twelve patients had acute nonperforated appendicitis (62%). Mean duration of operation was 58 ± 5.6 (30-135) minutes vs 43 ± 3.6 (30-85) minutes for standard LAP-A. Two patients were converted to a transumbilical appendectomy, one for inability to maintain a pneumoperitoneum and one for extensive adhesions. Postoperative complications consisted of one wound seroma. No wound infections, hernias, readmissions, or difference in length of stay were noted.

Conclusion

The SILS approach for acute appendicitis is feasible in the pediatric population even in patients as young as 19 months. Operating room times are somewhat longer than with LAP-A, but should decrease with improved instrumentation and experience. Larger studies and further technical refinements are needed before its widespread implementation.     

The Canadian pediatric surgery workforce: A 5-year prospective study

BackgroundIn 2014, a survey study of the Canadian pediatric surgery workforce predicted a need for 2 new pediatric surgeons/yr. in Canada. We sought to assess these predictions and evaluate the status of the workforce.MethodsWith IRB approval, a web-based survey was sent to pediatric surgery division chiefs in Canada each year (2013–2017). The survey data included: number of practicing pediatric surgeons, full time equivalent (FTE) positions, and fellowship graduates.ResultsThere was a 100% response rate (18 divisions). From 2013 to 2017, the number of practicing pediatric surgeons and FTE positions increased (73 to 78, and 64.6 to 67.5, respectively). Eleven positions were vacated (4 retirement, 7 new practice), and 18 were filled. Eight were filled by new Canadian graduates, 7 by Canadians previously working in Canada or abroad, and 3 by European surgeons. Thirty-eight fellows completed training in Canada, including 24 non-Canadians who all left Canada. Nine Canadians who started practicing immediately after fellowship took positions in Canada (5) and the US (4).ConclusionsPredictions made in 2014 were largely accurate. There has been modest growth in the Canadian pediatric surgery workforce over the last 5 years. A significant mismatch continues to exist between Canadian pediatric surgery graduates and attending staff positions.Type of studySurvey.Level of evidenceV     

Giovanni Battista Morgagni and his contribution to pediatric surgery

Pediatric surgery is a less than a century old surgical specialty. However, early knowledge of human malformations and pediatric surgical conditions dates back to centuries before. One of the main contributors to progress in these fields was Giovanni Battista Morgagni (1682-1771), who also had a substantial weight in the development of future pediatric surgery. With his masterpiece De Sedibus et Causis Morborum per Anatomen Indagatis (On the Seats and Causes of Diseases Investigated by Anatomy) (1761), he set the basis for modern pathology.In this textbook, Morgagni was the first to describe anatomical elements like the trigonum sternocostale dextrum (the Morgagni's foramen), the appendix testis (the Morgagni's hydatid), and the vertical folds of distal rectum (the Morgagni's columns). He was also the first to describe pediatric pathological conditions like epispadia, meconium peritonitis, Crohn's disease, and coarctation of the aorta. Finally, he substantially contributed to the understanding of the pathophysiology of conditions like the vesico-ureteral reflux, the anterior wall defects (gastroschisis/omphalocele), and the spina bifida. For this, it was said of him: “If all the anatomical findings made by Morgagni should bear his name, probably one third of human body would be called Morgagni's.”     

The spectrum and management of noniatrogenic vascular trauma in the pediatric population

Background

To describe the spectrum of noniatrogenic pediatric vascular injuries and their outcomes at a large tertiary pediatric hospital.

National prevalence of urogenital pain and prostatitis‐like symptoms in Australian men using the National Institutes of Health Chronic Prostatitis Symptoms Index

Study Type – Prognosis (cohort)
Level of Evidence 2a

OBJECTIVE

To provide a summary, using the National Institutes of Health Chronic Prostatitis Symptoms Index (NIH‐CPSI), of the prevalence of prostatitis‐like symptoms in a population‐based sample of Australian men.

SUBJECTS AND METHODS

Participants were Australian men aged 16–64 years recruited as part of the Australian Longitudinal Study of Health and Relationships: a nationally representative study. In all, 1346 men completed an extensive questionnaire which included the NIH‐CPSI. The index identifies six types of urogenital pain, the presence of urinary problems, and effects on quality of life. Men who reported perineal and/or ejaculatory pain or discomfort and a total NIH‐CPSI pain score of ≥4 were considered as having prostatitis‐like symptoms.

RESULTS

Based on a weighted population of 1373 men, some form of urogenital pain was reported by 105 (7.6%) men; with 2.8% of men reporting more than one type of urogenital pain. The mean (range) NIH‐CPSI pain score for men reporting pain was 6.2 (5.6–6.8); for all men the mean score was 0.5 (0.4–0.6). About 20% of men (284) were considered to have urinary problems. The mean urinary symptom score for all men was 0.9 (0.9–1.0). The mean total NIH‐CPSI score for men reporting pain was 13.3 (12.0–14.7) and for all men it was 2.6 (2.3–2.8). The estimated prevalence of prostatitis‐like symptoms was ≈2%.

CONCLUSIONS

Using the NIH‐CPSI the estimated prevalence for urogenital pain in Australian men is 8%; an estimated 3% of men experience pain from more than one urogenital location. The estimated prevalence of prostatitis‐like symptoms in Australian men is 2%. Almost a third of Australian men experiencing urogenital pain or prostatitis‐like symptoms would be less than satisfied if this was to be ongoing for the rest of their life.     

The Finnish version of The National Institutes Of Health Chronic Prostatitis Symptom Index correlates well with the visual pain scale: translation and results of a modified linguistic validation study

Authors from Finland have assessed a version in their language of the National Institutes of Health-Chronic Prostatitis Symptom Index; they found that their translated version was valid and easily understandable in the management of the symptoms of chronic pelvic pain syndrome. They felt it should be used as a primary outcome measure in studies with these patients. There are three papers in this issue relating to the effect of drugs on LUTS; the first of these is a pooled analysis of three double-blind placebo-controlled studies into the safety and efficacy of the 10 mg dose of alfuzosin. The second evaluates the effect on quality-of-life issues of treatment with dutasteride. Finally, authors from Australia compare the effect of a Serenoa repens extract with placebo for LUTS. OBJECTIVES: To provide a fluent and easily comprehensible Finnish version of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and to study its linguistic validity and correlation with a visual pain scale (VAS). PATIENTS AND METHODS: The double-back translation method with two interim modifications was used to produce the Finnish version of the NIH-CPSI. The validity was tested by presenting the questionnaire to 155 men with clinically confirmed chronic pelvic pain syndrome (CPPS) and 12 controls with no previous urological symptoms. Convergent validity of the NIH-CPSI was tested by determining the correlation between the Finnish NIH-CPSI and VAS. Patients' and urologists' opinions about the utility of the Finnish NIH-CPSI were also reviewed. RESULTS: The total Finnish NIH-CPSI scores and the pain domain and voiding symptom domain scores differed significantly (P < 0.001) between the groups, suggesting good discriminant validity of the symptom index. The NIH-CPSI scores correlated well with the VAS (Pearson's correlation 0.76). The preciseness and comprehensibility of the questionnaire were consistently evaluated to be 'good' or 'excellent' both by patients and urologists. CONCLUSIONS: The Finnish version of the NIH-CPSI is valid and easily comprehensible for measuring CPPS symptoms. In addition, it provides good discriminant and convergent validity in distinguishing CPPS symptoms and should be used as primary outcome measure in CPPS studies.