Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials.

INTRODUCTION: Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients. METHODS AND ANALYSIS: Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention. ETHICS AND DISSEMINATION: The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website. TRIAL REGISTRATION NUMBERS: NCT05575128, NCT05685511, NCT05697835, pre-results.

The CCJR® Gerard A. Engh Excellence in Knee Research Award: Remote Monitoring of Sleep Disturbance Following Total Knee Arthroplasty: A Cautionary Note.

BACKGROUND: Sleep disturbances are common after total knee arthroplasty (TKA). Despite the rising popularity of wearables to track sleep, little evidence exists in the arthroplasty literature regarding their efficacy. We aimed to correlate validated wearable sleep metrics with patient-reported sleep quality following TKA. METHODS: Patients undergoing primary TKA were consecutively enrolled. Patients used a wearable device preoperatively and 90 days postoperatively to track five previously-validated measures of sleep. Each month, they rated their sleep quality. Wearable sleep data was correlated with patient-reported sleep quality using a point biserial correlation test. Categorical data were compared using Chi-square tests. A total of 110 patients were included. RESULTS: Preoperatively, 20.8% of patients reported "fairly bad" or "very bad" sleep; this increased to 44.4% 30 days postoperatively, then decreased to 26.5% 60 days postoperatively, and to 20.2% 90 days postoperatively. At 30 days postoperatively, time in bed, time asleep, and minutes of rapid eye movement sleep weakly correlated with patient-reported sleep quality (correlations 0.356, 0.345, and 0.345, respectively; P < .001). Sleep quality did not correlate with any wearable metric collected 60 or 90 days postoperatively. CONCLUSIONS: Patient-reported sleep quality following TKA initially worsened postoperatively, then improved to preoperative levels by 90 days. Time in bed, time asleep, and rapid eye movement sleep minutes only weakly correlated with patient-reported sleep quality at 30 days; no other correlations were detected. Surgeons that utilize remote monitoring following TKA should be aware that surrogate measures generated from these devices may correlate weakly, if at all, with the patient-reported outcome of the parameter being studied.

Ten Year Outcomes of Contemporary Total Hip Arthroplasty in Adolescent and Young Adult Patients are Favorable.

BACKGROUND: The purpose of this study was to assess 10-year patient-reported outcome measures, complications, polyethylene wear-rates, and implant survivorships in patients ≤30 years of age treated with contemporary total hip arthroplasty (THA). METHODS: We retrospectively assessed 121 patients (144 hips) who underwent THA at age ≤30 years (mean 23 [range, 11 to 30]) at an average follow-up duration of 10.7 years (range, 8 to 17). Highly-crosslinked polyethylene acetabular liners were used in all cases. Femoral heads were ceramic (74%) or cobalt-chrome (26%). There were 52 hips (36%) that had previous surgery and 31 hips (22%) were in patients who had associated major systemic comorbidities. We analyzed the modified Harris Hip scores, University of California Los Angeles Activity Scores, major complications, polyethylene wear-rates, and implant survivorships. RESULTS: At final follow-up, the average modified Harris Hip scores improved from 47 (±15.1) to 81 (±19.5) with an average 34-point improvement. The University of California Los Angeles scores improved from 4.0 (±2.3) to 6.0 (±2.4). The major complication rate was 5.6%. There were 6 hips (4.2%) that were revised. Indications for revision included instability (3, 2.1%), late infection (1, 0.7%), liner dissociation (1, 0.7%), and acetabular loosening (1, 0.7%). Mean linear (0.0438 mm/y) and volumetric (29.07 mm3/y) wear rates were low. No periprosthetic osteolysis was detected in any hip. Survivorship free from revision for any reason was 97.2, 95.8, and 95.8% at 5, 10, and 15 years. CONCLUSIONS: Contemporary THA in patients ≤30 years of age is associated with marked clinical improvements at 10-year follow-up and encouraging survivorship estimates at 15 years.

2023 American College of Rheumatology and American Association of Hip and Knee Surgeons Clinical Practice Guideline for the Optimal Timing of Elective Hip or Knee Arthroplasty for Patients With Symptomatic Moderate-to-Severe Osteoarthritis or Advanced Symptomatic Osteonecrosis With Secondary Arthritis for Whom Nonoperative Therapy Is Ineffective.

OBJECTIVE: To develop evidence-based consensus recommendations for the optimal timing of hip and knee arthroplasty to improve patient-important outcomes including, but not limited to, pain, function, infection, hospitalization, and death at 1 year for patients with symptomatic and radiographic moderate-to-severe osteoarthritis or advanced symptomatic osteonecrosis with secondary arthritis of the hip or knee who have previously attempted nonoperative therapy, and for whom nonoperative therapy was ineffective, and who have chosen to undergo elective hip or knee arthroplasty (collectively referred to as TJA). METHODS: We developed 13 clinically relevant population, intervention, comparator, outcomes (PICO) questions. After a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the quality of evidence (high, moderate, low, or very low), and evidence tables were created. A Voting Panel, including 13 physicians and patients, discussed the PICO questions until consensus was achieved on the direction (for/against) and strength (strong/conditional) of the recommendations. RESULTS: The panel conditionally recommended against delaying TJA to pursue additional nonoperative treatment including physical therapy, nonsteroidal antiinflammatory drugs, ambulatory aids, and intraarticular injections. It conditionally recommended delaying TJA for nicotine reduction or cessation. The panel conditionally recommended delay for better glycemic control for patients who have diabetes mellitus, although no specific measure or level was identified. There was consensus that obesity by itself was not a reason for delay, but that weight loss should be strongly encouraged, and the increase in operative risk should be discussed. The panel conditionally recommended against delay in patients who have severe deformity or bone loss, or in patients who have a neuropathic joint. Evidence for all recommendations was graded as low or very low quality. CONCLUSION: This guideline provides evidence-based recommendations regarding the optimal timing of TJA in patients who have symptomatic and radiographic moderate-to-severe osteoarthritis or advanced symptomatic osteonecrosis with secondary arthritis for whom nonoperative therapy was ineffective to improve patient-important outcomes, including pain, function, infection, hospitalization, and death at 1 year. We acknowledge that the evidence is of low quality primarily due to indirectness and hope future research will allow for further refinement of the recommendations.

2023 American College of Rheumatology and American Association of Hip and Knee Surgeons Clinical Practice Guideline for the Optimal Timing of Elective Hip or Knee Arthroplasty for Patients With Symptomatic Moderate-to-Severe Osteoarthritis or Advanced Symptomatic Osteonecrosis With Secondary Arthritis for Whom Nonoperative Therapy Is Ineffective.

OBJECTIVE: To develop evidence-based consensus recommendations for the optimal timing of hip and knee arthroplasty to improve patient-important outcomes including, but not limited to, pain, function, infection, hospitalization, and death at 1 year for patients with symptomatic and radiographic moderate-to-severe osteoarthritis or advanced symptomatic osteonecrosis with secondary arthritis of the hip or knee who have previously attempted nonoperative therapy, and for whom nonoperative therapy was ineffective, and who have chosen to undergo elective hip or knee arthroplasty (collectively referred to as TJA). METHODS: We developed 13 clinically relevant population, intervention, comparator, outcomes (PICO) questions. After a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the quality of evidence (high, moderate, low, or very low), and evidence tables were created. A Voting Panel, including 13 physicians and patients, discussed the PICO questions until consensus was achieved on the direction (for/against) and strength (strong/conditional) of the recommendations. RESULTS: The panel conditionally recommended against delaying TJA to pursue additional nonoperative treatment including physical therapy, nonsteroidal antiinflammatory drugs, ambulatory aids, and intraarticular injections. It conditionally recommended delaying TJA for nicotine reduction or cessation. The panel conditionally recommended delay for better glycemic control for patients who have diabetes mellitus, although no specific measure or level was identified. There was consensus that obesity by itself was not a reason for delay, but that weight loss should be strongly encouraged, and the increase in operative risk should be discussed. The panel conditionally recommended against delay in patients who have severe deformity or bone loss, or in patients who have a neuropathic joint. Evidence for all recommendations was graded as low or very low quality. CONCLUSION: This guideline provides evidence-based recommendations regarding the optimal timing of TJA in patients who have symptomatic and radiographic moderate-to-severe osteoarthritis or advanced symptomatic osteonecrosis with secondary arthritis for whom nonoperative therapy was ineffective to improve patient-important outcomes, including pain, function, infection, hospitalization, and death at 1 year. We acknowledge that the evidence is of low quality primarily due to indirectness and hope future research will allow for further refinement of the recommendations.

2023 American College of Rheumatology and American Association of Hip and Knee Surgeons Clinical Practice Guideline for the Optimal Timing of Elective Hip or Knee Arthroplasty for Patients With Symptomatic Moderate-to-Severe Osteoarthritis or Advanced Symptomatic Osteonecrosis With Secondary Arthritis for Whom Nonoperative Therapy Is Ineffective.

OBJECTIVE: To develop evidence-based consensus recommendations for the optimal timing of hip and knee arthroplasty to improve patient-important outcomes including, but not limited to, pain, function, infection, hospitalization, and death at 1 year for patients with symptomatic and radiographic moderate-to-severe osteoarthritis or advanced symptomatic osteonecrosis with secondary arthritis of the hip or knee who have previously attempted nonoperative therapy, and for whom nonoperative therapy was ineffective, and who have chosen to undergo elective hip or knee arthroplasty (collectively referred to as TJA). METHODS: We developed 13 clinically relevant population, intervention, comparator, outcomes (PICO) questions. After a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the quality of evidence (high, moderate, low, or very low), and evidence tables were created. A Voting Panel, including 13 physicians and patients, discussed the PICO questions until consensus was achieved on the direction (for/against) and strength (strong/conditional) of the recommendations. RESULTS: The panel conditionally recommended against delaying TJA to pursue additional nonoperative treatment including physical therapy, nonsteroidal antiinflammatory drugs, ambulatory aids, and intraarticular injections. It conditionally recommended delaying TJA for nicotine reduction or cessation. The panel conditionally recommended delay for better glycemic control for patients who have diabetes mellitus, although no specific measure or level was identified. There was consensus that obesity by itself was not a reason for delay, but that weight loss should be strongly encouraged, and the increase in operative risk should be discussed. The panel conditionally recommended against delay in patients who have severe deformity or bone loss, or in patients who have a neuropathic joint. Evidence for all recommendations was graded as low or very low quality. CONCLUSION: This guideline provides evidence-based recommendations regarding the optimal timing of TJA in patients who have symptomatic and radiographic moderate-to-severe osteoarthritis or advanced symptomatic osteonecrosis with secondary arthritis for whom nonoperative therapy was ineffective to improve patient-important outcomes, including pain, function, infection, hospitalization, and death at 1 year. We acknowledge that the evidence is of low quality primarily due to indirectness and hope future research will allow for further refinement of the recommendations.

Sleep Disturbances Following Total Knee Arthroplasty.

BACKGROUND: Sleep disturbances are common after total knee arthroplasty (TKA), yet literature examining sleep and postoperative pain remains sparse. With the use of wearable devices, convenient objective remote sleep monitoring is now possible. We aimed to measure patient sleep following TKA using validated questionnaires and wearable devices to compare sleep patterns to pain scores 90 days postoperatively. METHODS: Adult patients with body mass index < 45 undergoing unilateral primary TKA were enrolled. Patients wore a monitor, which tracked sleep duration and disturbances (getting up at least once during the night). They completed weekly Pittsburgh Sleep Quality Index (PSQI) questionnaires and visual analog scale (VAS) pain scores. Sleep patterns were compared with pain scores and sleep duration was compared with PSQI responses. RESULTS: There were 110 patients included with 54.5% women; average age was 64 years (range, 43-80). VAS scores decreased postoperatively. PSQI overall sleep scores, sleep quantity, and sleep quality worsened for the first 30 days then improved past baseline levels by 90 days. Recorded sleep duration did not change, and recordings did not correlate at any point with VAS scores. PSQI overall score and sleep quantity did not correlate with VAS. At 30 days postoperatively, patients reporting "very bad" sleep had significantly worse VAS scores than those reporting "bad" sleep. CONCLUSION: Patient-reported sleep quality (very bad sleep) correlated well with VAS pain score at 30 days, while sleep duration (monitored or patient-reported) did not correlate with any clinical measure and does not seem to be a useful metric in assessing TKA outcome.

Sleep Disturbances and Disorders in Patients with Knee Osteoarthritis and Total Knee Arthroplasty.

➤: There is increasing evidence that patient-reported outcomes following total knee arthroplasty (TKA) are associated with psychosocial factors and pain catastrophizing. Sleep disturbance, pain, and mental health have a complex interaction, which, if unrecognized, can be associated with impaired patient-reported outcomes and dissatisfaction following TKA. ➤: The gold standard of objective sleep assessment is polysomnography, which is not feasible to use routinely for TKA patients. Wearable devices are a validated and less costly alternative. ➤: Subjective sleep measures, such as the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, or Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive test sleep domains, are simple to administer and provide additional insight into sleep disturbance. Although objective and subjective measures do not correlate precisely, they can be informative together. ➤: Sleep disturbances in the elderly population are common and multifactorial in etiology, stemming from the interplay of sleep disorders, medication side effects, and pain. Commonly prescribed medications following TKA as well as postoperative pain can exacerbate underlying sleep disturbances. ➤: Obstructive sleep apnea (OSA) is prevalent in patients seeking TKA. In the setting of OSA, postoperative opioids can cause respiratory depression, resulting in consequences as severe as death. A standardized multimodal pain protocol including anti-inflammatories and gamma-aminobutyric acid (GABA) analogues may allow for decreased reliance on opioids for pain control. ➤: Surgeons should reassure patients that postoperative sleep disturbance is common and transient, collaborate with the patient's primary care doctor to address sleep disturbance, and avoid prescription of pharmaceutical sleep aids.

Radiographic and clinical analysis of a Porous-coated metaphyseal cone for revision total Knee arthroplasty.

BACKGROUND: The aim of this study was to evaluate the radiographic and clinical outcomes of a recently introduced metaphyseal cone system for revision TKA. METHODS: 73 revision TKAs in 72 patients were retrospectively reviewed. All patients had a minimum of 2-year clinical follow-up (mean 34.1 months; range 24.0 to 50.3 months). 114 Metaphyseal cones (64 tibial and 50 femoral) of a single manufacturer were implanted. The most common indications for revision were aseptic loosening (56.9%), second stage reimplantation for periprosthetic joint infection (PJI; 26.4%), and instability (12.5%). All femoral and tibial stems were press-fit cementless stems. RESULTS: Ten of 72 patients underwent re-revision: six for infection (8.3%), two for instability (2.8%), one (1.4%) for patellar tendon rupture and one (1.4%) for femoral component loosening (a cone was not utilized at index revision). Two patients had loose cones (one with an isolated tibial cone and one with both femoral and tibial cones) associated with loose implants but declined re-revision. Aseptic survivorship of our patient cohort free from any re-revision surgery was 95.9% at 2 years (95% CI 87.4-98.7%) and 96.5% of cones demonstrated radiographic evidence of osseointegration. At 2-years, the Knee Society Score (KSS) improved from a mean of 17.2 points preoperatively to 57.8 points (p <.0001). CONCLUSIONS: Porous-coated metaphyseal cones from this manufacturer demonstrate excellent aseptic survivorship and radiographic evidence of osseointegration similar to prior designs when used with cementless stems.

James A. Rand Young Investigator's Award: Questioning the "Nickel Free" Total Knee Arthroplasty.

BACKGROUND: A study was performed to measure metal ions present in the knee joint after performing a total knee arthroplasty (TKA) with standard cobalt chromium (CoCr) components as well as with "nickel-free" oxidized zirconium femoral and titanium tibial (OxZr/Ti) components. METHODS: Knee joint fluid was collected prior to arthrotomy, and on postoperative day one to determine the amount of metal debris generated when performing a TKA with standard instrumentation from consecutive cases with CoCr components (n = 24) and OxZr/Ti components (n = 16). RESULTS: CoCr implant patients had statistically higher levels of nickel (Ni) (29.7%, P = .033), cobalt (Co), (1,100.7%, P < .0001) and chromium (Cr) (118.9%, P < .0001) postoperatively. The cutting blocks and sawblades do not contain Co, which therefore must have come from the components. The metal ions generated from the sawblades and cutting blocks, therefore, could be discerned from the OxZr/Ti whose components don't contain Co, Cr, or Ni. The OxZr patients had significantly higher Cr (9.5×, P < .001) and Ni (5.1×, P < .001) post-TKA vs pre-TKA; Co levels were not significantly different as expected with the absence of Co in the components (P = .60). The Ni levels generated in performing an Oxinium TKA was 3.3 times higher than when performing a CoCr TKA (1.37 vs. 41 ppb, P < .001). CONCLUSIONS: The substantial degree of Ni generation resulting from performing a hypoallergenic "nickel-free" TKA calls into questions the rationale of utilizing more expensive lower Ni components on the basis of known or suspected Ni or Cr allergy.

Is Previous Periacetabular Osteotomy Associated with Pregnancy, Delivery, and Peripartum Complications?

BACKGROUND: Surgical candidates for periacetabular osteotomy are commonly women of reproductive age with symptomatic acetabular dysplasia. However, little is known about how this surgical intervention contributes to the decision to become pregnant, obstetrical counseling regarding delivery, mode of delivery, or pregnancy-related complications. QUESTIONS/PURPOSES: (1) Does a history of periacetabular osteotomy affect a patient's decision to become pregnant or does it affect obstetrical counseling regarding the safety of pregnancy and childbirth? (2) Is history of periacetabular osteotomy associated with in an increased risk of undergoing cesarean section compared with the national average? (3) Is a history of periacetabular osteotomy associated with increased complications, decreased infant birth weight, preterm delivery? METHODS: In conjunction with obstetrician colleagues, we created a survey to investigate patient attitudes toward pregnancy, mode of delivery, pregnancy-related complications, and obstetrical counseling among female patients who previously underwent periacetabular osteotomy. A retrospective cohort of reproductive-age women who underwent periacetabular osteotomy between 2008 and 2015 completed a mailed survey or telephone interview. All 96 patients who were contacted were asked if the history of periacetabular osteotomy affected their decision to become pregnant. Our cohort included 31 patients who had undergone periacetabular osteotomy and had a subsequent pregnancy and delivery with a total of 38 pregnancies resulting in 41 births. A binomial test was used to determine if the rates of cesarean section, low birth weight, or preterm delivery were different from the documented US national average as published by the National Vital Statistics Report and CDC. RESULTS: One patient of 31 felt her periacetabular osteotomy negatively affected the appearance of her child; this surgical history affected 6.5% of patients (2 of 31) positively. Fifty-five percent (17 of 31) patients reported that their obstetrician expressed concern that their history of periacetabular osteotomy could affect their ability to carry to term or deliver vaginally. With a history of periacetabular osteotomy, 53% of deliveries (20 of 38) underwent cesarean section. This is higher than the national average of 32% (odds ratio 0.424 [95% confidence interval 0.214 to 0.837]; p = 0.006). Only one patient with a periacetabular osteotomy suffered a pregnancy-related complication. In singleton pregnancy after periacetabular osteotomy the preterm delivery rate was 14% (5 of 35) and the percentage of low-birth-weight infants was 2.9% (1 of 35). These percentages are not different from US data published by the National Vital Statistics Report, which reports an 8% preterm delivery rate (OR 0.523 [95% CI 0.154 to 1.772]; p = 0.1723) and 6.4% low birth weight (OR 2.34 [95% CI 0.607 to 9.025]; p = 0.3878) in singleton pregnancies. CONCLUSIONS: In this small survey study, we found no differences in terms of complications, preterm delivery or low birth weight infants between patients who had a history of periacetabular osteotomy and normative national data regarding complications of pregnancy and delivery. However, we did note that patients with a history of periacetabular osteotomy were more likely to deliver future children by cesarean section, which could be attributable to obstetrician preference as most obstetricians in another small survey study have expressed concern about patients with a history of periacetabular osteotomy. Future studies should aim to increase the knowledge of the association of periacetabular osteotomy and delivery method, specifically with transition to cesarean for failure to progress during labor. Future consideration of using the Academic Network of Conservational Hip Outcomes Research repository to develop National Surgical Quality Improvement Program data may help to elucidate this relationship more clearly and help guide appropriate indications for scheduled cesarean sections in the setting of prior pelvic osteotomy. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Avascular Necrosis of the Sesamoids.

Avascular necrosis (AVN) of the sesamoid is pathology of the medial or lateral hallucal sesamoid resulting in pain under the first metatarsophalangeal joint often presenting in young female athletes. There is overlap of stress fracture, nonunion, and AVN that makes defining the diagnosis difficult but the treatment and outcomes are similar. The most reliable operative treatment used for AVN of the sesamoid is an accumulation of anatomic and mechanical factors with repetitive microtrauma. Nonoperative modalities are designed to offload the sesamoid. The only operative treatment used for AVN of the sesamoid is excision of the involved bone, which results most commonly in complete patient satisfaction.

Transhumeral Portal for Arthroscopic Glenohumeral Resurfacing Procedures: A Cadaveric Study of the Safety and Accuracy.

PURPOSE: To evaluate the safety and accuracy of a transhumeral portal to arthroscopically access and prepare the glenohumeral articular surface without subscapularis transection or glenohumeral dislocation. METHODS: In 10 fresh-frozen cadaveric shoulders, we used a transhumeral portal and an anterior mini-open rotator interval exposure to arthroscopically prepare the humeral and glenoid articular surfaces. To evaluate our technique, we measured the distance from the portal to the branches of the axillary nerve and the biceps groove on the humeral extra-articular surface, the angle of trajectory of the portal through the humerus, and the accuracy of targeting the center-center of the humeral and glenoid surfaces. RESULTS: The transhumeral portal allows perpendicular access to the humeral and glenoid articular surfaces without damage to the subscapularis, supraspinatus, or axillary nerve. The transhumeral portal courses an average of 20.7 ± 15.0 mm from the closest terminal branch of the anterior branch of the axillary nerve, enters the humerus 8.8 ± 2.7 mm lateral to the biceps groove, and traverses the humerus at an angle of 46.0° ± 4.3° relative to the humeral intramedullary axis. Arthroscopic guidance resulted in an average distance of 8.1 ± 5.6 mm from the humeral center and 3.9 ± 1.0 mm from the glenoid center. CONCLUSIONS: Creating an arthroscopic transhumeral portal allows perpendicular access to the humeral and glenoid articular surfaces without injury to the axillary nerve, subscapularis transection, or dislocation of the glenohumeral joint. However, this transhumeral portal did traverse within 5 mm of a terminal branch of the anterior branch of the axillary nerve in 20% of our specimens. CLINICAL RELEVANCE: These findings describe an arthroscopic transhumeral portal that achieves perpendicular access to the glenohumeral joint surfaces without transection of the subscapularis or dislocation of the glenohumeral joint. This transhumeral portal may assist in articular cartilage repair and resurfacing of the glenohumeral joint.

Are our publications failing the inspection?: a review of the publications in rectal cancer surgery between 2002 and 2012.

BACKGROUND: Quality of publications is considered a subjective measurement, and more weight is placed on prospective studies, especially randomized clinical trials and meta-analyses. OBJECTIVE: This study describes the type of publications and evaluates the quality of randomized clinical trials and review articles using an objective measurement. DATA SOURCES: Medline (PubMed) is the data source for this work. STUDY SELECTION: We used the terms "rectal neoplasms/surgery" and the filters "10 years," "humans," and "English." MAIN OUTCOME MEASURES: We measured compliance with checklist items. Randomized clinical trials were reviewed using the Consolidates Standards of Reporting Trials statement; systematic reviews/meta-analyses were reviewed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. RESULTS: A total of 3603 articles were identified: 20.8% were case report/series, 20.5% were retrospective cohorts, 14.0% were reviews or meta-analyses, 16.4% were prospective cohorts, 14.0% were other types of articles (comments, letters, or editorials), 5.5% were clinical trials (phase I/II), 4.2% were randomized clinical trials, and 4.4% were cross-sectional studies. We reviewed 108 randomized clinical trials; the maximum score possible was 74.0, the average score was 44.6 (range, 20.0-64.0), 4 (3.7%) were graded as "excellent," 21 (19.4%) were "good," 44 (40.7%) were "deficient," and 39 (36.1%) were graded as "fail." The predictors of higher scores for randomized clinical trials were year of publication after 2007 (p = 0.00), higher impact factor (p = 0.03), and declared funding (p = 0.01). Twenty-nine meta-analyses were reviewed; the average score was 19.64 (range, 12.0-25.0); 5 articles (17.2%) were graded as "excellent," 12 (41.4%) were "good," 10 (34.5%) were "deficient," and 2 (6.9%) were "fail." LIMITATIONS: Only 1 electronic database was used, so we lacked a validated score. In addition, the search terms did not include "colorectal." CONCLUSIONS: A total of 20.8% of the articles published were case reports and 25.0% of the articles were prospective or clinical trials. Although randomized clinical trials and systematic reviews provide the highest level of evidence, publications with missing data limit replication of the study and affect the generalizability of results to other populations. To improve the quality of our publications, authors, reviewers, and journal editors should consider the endorsement of standardize checklists.