Patient-centred outcomes in clinical research: does it really matter?

‘It does not matter whether the degree of patients’satisfaction reflects the competence of the physician or thequality of care. The important thing is that if patients aredissatisfied, health care has not achieved its goal’.¹ This statement, which was published 16 yr ago, reflects the(growing) importance of the technical and non-technical dimensionof outcome.² The technical aspect attempts to assess the skilland competence of professionals, and the ability of diagnosticor therapeutic procedures to accomplish what they are meantto, or, from the patients’ perspective: do they reallyget what they need? Patients quite rightly expect that the carethey receive is methodologically     

Obesity in total hip arthroplasty—does it really matter?: A meta-analysis

Background and purpose

Discussion persists as to whether obesity negatively influences the outcome of hip arthroplasty. We performed a meta-analysis with the primary research question of whether obesity has a negative effect on short- and long-term outcome of total hip arthroplasty.

Methods

We searched the literature and included studies comparing the outcome of hip arthroplasty in different weight groups. The methodology of the studies included was scored according to the Cochrane guidelines. We extracted and pooled the data. For continuous data, we calculated a weighted mean difference and for dichotomous variables we calculated a weighted odds ratio (OR). Heterogeneity was calculated using I₂ statistics.

Results

15 studies were eligible for data extraction. In obese patients, dislocation of the hip (OR = 0.54, 95% CI: 0.38–0.75) (10 studies, n = 8,634), aseptic loosening (OR = 0.64, CI: 0.43–0.96) (6 studies, n = 5,137), infection (OR = 0.3, CI: 0.19–0.49) (10 studies, n = 7,500), and venous thromboembolism (OR = 0.56, CI: 0.32–0.98) (7 studies, n = 3,716) occurred more often. Concerning septic loosening and intraoperative fractures, no statistically significant differences were found, possibly due to low power. Subjective outcome measurements did not allow pooling because of high heterogeneity (I₂ = 68%).

Interpretation

Obesity appears to have a negative influence on the outcome of total hip replacement.Obesity has reached epidemic proportions in the USA, and the rest of the well-developed world is expected to follow. Since obesity is a well-documented risk factor for the development of osteoarthritis (Sturmer et al. 2000, Flugsrud et al. 2006), an increased need for joint arthroplasty in obese people can be expected. Surgery on obese patients can lead to longer duration of the operative procedures themselves, with higher complication rates and longer hospital stays, and some authors have even suggested refusal of elective surgery in obese patients (Fehring et al. 2007).A controversy that has flared up during the last decennium is whether obesity might also influence the functional results and survival of total hip arthroplasty (THA), with studies showing either different or similar outcome compared to normal-weight patients. For both outcomes, different explanations have been postulated. McClung et al. (2000), for example, found that a higher BMI was associated with lower activity, resulting in less polyethylene wear in these patients, since wear is a function of use and not time. On the other hand, higher forces acting on the prosthesis in obese patients may lead to early loosening.Generally, a person with a BMI between 25 and 30 is categorized as overweight, and someone with a BMI of greater than 30 is obese. In this meta-analysis, we evaluated the results of all published trials comparing outcome and survival of primary THA between different BMI groups (BMI of < 30 and of > 30). Our main research question was whether obesity has a negative effect on the short- and long-term outcome of total hip arthroplasty.     

Partial or non-union after triple arthrodesis in children: does it really matter?

Purpose

Triple arthrodesis is a commonly performed salvage procedure to correct hindfoot deformity. Non-union is considered an undesirable radiographic outcome; however, the clinical ramifications of this are not as well defined. The purpose of this study was to determine the incidence of partial or complete radiographic non-union after triple arthrodesis in children and characterize the clinical consequences.

Methods

An IRB-approved retrospective review of triple arthrodesis surgeries in patients less than 16 years of age performed by a single surgeon (DSW) identified 159 cases meeting the inclusion criteria. Plain radiographs were reviewed for bony fusion (defined as over 80 % radiographic bony union of the subtalar, calcaneocuboid, and talonavicular bones) and charts for clinical outcomes (pain, return to activity, and subsequent hindfoot surgeries). Statistics were used to compare the fused and unfused cases, with p < 0.05 considered to be significant.

Results

Of the 159 cases included in the study, 9 % did not achieve at least 80 % plain film radiographic union. The fused and unfused groups had similar clinical outcomes. Only one patient required surgery for sequelae of symptoms arising from a pseudoarthrosis related to the triple arthrodesis. The fused and unfused groups were similar in terms of gender and pin removal time, but differed significantly in surgical age and underlying diagnosis.

Conclusions

This is one of the largest case series of pediatric triple arthrodesis surgery presented in the literature. This study demonstrated that good clinical outcomes can be achieved despite the lack of radiographic union after triple arthrodesis surgery in children.

Level of evidence

IV.

     

Difficult mask ventilation: does it matter?

We discuss the relevance of finding a patient's lungs difficult to ventilate by facemask during the course of anaesthetic induction. In particular, we discuss the issue of whether it is advisable or unnecessary to check the ability to ventilate by facemask before administering a neuromuscular blocking agent. In the light of advances in supraglottic airway technology it has become possible to insert these devices very soon after induction and in a wider variety of patients. Similarly, the development of videolaryngoscopes and rapidly acting drugs such as rocuronium have raised the possibility of earlier, and possibly more successful, tracheal intubation, with the potential result that mask ventilation becomes redundant. However, we conclude by reaffirming its value in airway management strategies.     

Sevoflurane versus isoflurane: does it matter in renal transplantation?

Different inhalational anesthetics have various hemodynamic effects, either on the global circulation or on kidney perfusion. These drugs are also different concerning their potential for renal toxicity. The potential influence of the choice of the halogenated anesthetion in the outcome of kidney transplantation has not been previously studied, which was the purpose of this observational study. METHODS: We examined the hospital records and anesthesiology charts of 200 patients undergoing renal transplantation using general anesthesia. We divided these patients in two groups according to the inhalational anesthetic used during the kidney transplant: Isoflurane (n = 103) or sevoflurane (n = 97). The evaluated outcomes were creatinine values at 1, 3, and 6 months after transplantation, the start of diuresis (immediate, before the postoperative hour 4, or after hour 4), the need for postoperative dialysis and the incidence of graft rejection. RESULTS: The groups were not different concerning age, gender, or weight. We did not observe significant differences in the postoperative creatinine levels: P = .44, P = .91, and P = .88, respectively, at 1, 3, or 6 months. The immediate start of diuresis (77.7% in the isoflurane group and 70.1% in the sevoflurane group; P = .14), the need for postoperative dialysis (8.7% vs. 13.4%; P = .37), and the incidence of rejection (4.9% vs 9.3%, P = .22) were similar. CONCLUSION: Our study did not detect any effect of the choice of the inhalational anesthetic on the outcome of kidney transplantation.     

Blood product storage: does age really matter?

Red blood cell transfusion therapy has been used with the ultimate goal of enhancing oxygen delivery to vital organs and tissue beds, thus enhancing cellular function. Red blood cell transfusion therapy is also a long-standing practice, and since the 1950s it has only grown in utilization, especially within the United States. Recently, transfusion therapy has come under increased scrutiny with a desire to develop evidence-based therapeutic guidelines that not only decrease undue risk to the patient but also decrease the overutilization of this high-cost, low-availability product. Despite the development and implementation of these guidelines, significant complications associated with red cell therapy persist and may be related to storage of blood products. Recently, within the transfusion literature, there has been a renewed focus on red cell storage lesions and their contributions to perioperative outcomes. Several meta-analyses, and now a recently launched, multinational randomized controlled trial, have been initiated to help bring clarity to whether or not the length of product storage has any effect on patient outcomes. This review will focus on the nature of storage lesions, complications associated with storage, as well as a brief review of some of the more provocative literature surrounding this controversial topic.     

Fall from heights: does height really matter?

Introduction

Fall from heights is high energy injuries and constitutes a fraction of all fall-related trauma evaluations while bearing an increase in morbidity and mortality. We hypothesize that despite advancements in trauma care, the overall survivability has not improved in this subset of trauma patients.

Methods

All adult trauma patients treated after sustaining a fall from heights during a 40-month period were retrospectively reviewed. Admission demographics, clinical data, fall height (ft), injury patterns, ISS, GCS, length of stay, and mortality were reviewed.

Results

116 patients sustained a fall from heights, 90.4% accidental. A mean age of 37± 14.7 years, 86% male, and a fall height of 19 ± 10 ft were encountered. Admission GCS was 13 ± 2 with ISS 10 ± 11. Overall LOS was 6.6 ± 14.9 days and an ICU LOS of 2.8 ± 8.9 days. Falls ≥ 25 ft.(16%) had lower GCS 10.4 ± 5.8, increased ISS 22.6 ± 13.8, a fall height 37.9 ± 13.1 ft and associated increased mortality (p < 0.001). Mortality was 5.2%, a mean distance fallen of 39 ± 22 ft. and an ISS of 31.5 ±16.5. Brain injury was the leading cause of death, 50% with open skull fractures.

Conclusion

Level of height fallen is a good predictor of overall outcome and survival. Despite advances in trauma care, death rates remain unchanged. Safety awareness and injury prevention programs are needed to reduce the risk of high-level falls.

     

Trochanteric non-union in revision total hip arthroplasty: does it matter?

The aims of this study were to assess whether trochanteric non-union is an important factor in revision total hip arthroplasty in terms of postoperative morbidity. We studied prospectively 97 consecutive patients undergoing revision total hip arthroplasty in the years 1992-1996. All operations were performed by one surgeon through a Charnley trans-trochanteric approach. The patients were followed-up over a period of 1-4 years and at 12 months postsurgery were assessed using a modified scoring system devised by D'Aubigne. Anatomical union of the greater trochanter was assessed by an anterior-posterior pelvic radiograph at 12 months to decide if the greater trochanter was united in the correct anatomical position. The trochanteric non-union rate was 18.5% (18 out of 97 patients). There was no significant difference between the patients in terms of pain, function and satisfaction scores at one year between those with trochanteric union and those without. This study suggests that trochanteric non-union post revision total hip arthroplasty is not a cause of increased morbidity.     

Aortopulmonary collateral flow in the Fontan patient: does it matter?

BACKGROUND: The effects of aortopulmonary collaterals (APCs) on the outcome of a Fontan procedure are unclear. We undertook this study to define the incidence and extent of APC flow, identify risk factors for APC flow, and determine if APC flow has a measurable effect on the outcome of a Fontan procedure. METHODS: The APC flow was directly measured in 32 patients undergoing Fontan procedures from July 1997 to September 2000. The APC flow was measured in the operating room during total cardiopulmonary bypass, and was expressed as a percentage of total bypass pump flow. RESULTS: The APC flow ranged from 9% to 49% of total pump flow (median, 18%). Higher preoperative systemic oxygen saturation, pulmonary artery oxygen saturation, pulmonary to systemic flow ratio, and angiographic APC grade correlated with higher APC flow. There were no operative deaths; there was one Fontan takedown (APC flow = 14%). The APC flow had no significant effects on postoperative Fontan pressure, common atrial pressure, transpulmonary gradient, duration of effusions, or resource utilization after the Fontan procedures. CONCLUSIONS: In patients undergoing a Fontan procedure, APC flow is omnipresent, although its extent varies widely. Increased APC flow has no significant effect on the outcome of a Fontan procedure. This conclusion applies to patients who are well prepared for a Fontan procedure, but may not extend to patients at higher risk.     

Preoperative tracheobronchoscopy in newborns with esophageal atresia: does it matter?

Background/Purpose

Despite surgical refinements, perioperative use of tracheobronchoscopy (TBS) as part of surgical approach to esophageal atresia (EA) is still controversial. The purpose of this study was to evaluate the influence of preoperative TBS in newborns with EA in preventing complications and improving diagnosis and surgical treatment.

Methods

In the period ranging from 1997 to 2003, 62 patients with EA underwent preoperative TBS. The procedure was carried out with flexible bronchoscope maintaining spontaneous breathing. When a wide carinal fistula was found, this was mechanically occluded by Fogarty catheter and cannulated with rigid bronchoscopy. Type of EA, surgical procedure variations caused by TBS, and associated anomalies not easily detectable were recorded.

Results

Before TBS, the Gross classification of the 62 patients was as follows: type A, 9 patients; type B, none; type C, 51 patients. At TBS, however, 3 of 9 type A patients had an unsuspected proximal fistula (type B). These 3 patients, plus the 2 with H-type fistula, were repaired through a cervical approach. In 4 patients, previously undetected malformations of the respiratory tree (2 aberrant right upper bronchus and 2 hypoplastic bronchi) were found at TBS. Carinal fistulas in 14 type C patients were occluded by Fogarty catheter to improve ventilation during repair. No complications were observed. Overall, TBS was clinically useful in 28 (45.2%) of 62 patients, including 15 (24.2%) of 62 infants in whom it was crucial in modifying the surgical approach.

Conclusion

Tracheobronchoscopy is a useful and safe procedure and should be recommended in tertiary centers for babies with EA before surgical repair.     

Adequacy of dialysis in children: does small solute clearance really matter?

Measurement of dialysis adequacy relies on an assessment of small molecule clearance during the dialysis procedure. However, recent adult studies (HEMO and ADEMEX) that pushed clearance to maximally achievable levels within practical constraints of thrice-weekly hemodialysis or four times daily continuous ambulatory peritoneal dialysis failed to demonstrate improvements in patient outcome above current guidelines. The relatively low incidence of pediatric compared with adult end-stage renal disease limits large-scale study of pediatric dialysis. Several single-center pediatric studies demonstrate a lack of association between small solute clearance alone and patient growth. The aim of the current article is to review the relevant pediatric and adult studies of small solute clearance and put them in the context of optimal dialysis provision. While small solute clearances do indeed matter, clearance is not all that matters. Our quest to provide optimal dialysis requires that we also focus our attention on patient nutritional status, increased dialysis delivery (daily/nocturnal hemodialysis), and adjunctive dialysis modalities (hemofiltration and renal tubular replacement therapy).     

Establishing hand preference: why does it matter?

Hand preference has been associated with psychological and physical well-being, risk of injury, pathological irregularities, longevity, and cognitive function. To determine hand preference, individuals are often asked what hand they use to write with, or what hand is used more frequently in activities of daily living. However, relying only on one source of information may be misleading, given the strong evidence to support a disassociation between self-reported hand preference and outcomes of hand performance assessments. This brief communication is intended to highlight the various methods used to determine hand preference, to discuss the relationship between hand preference inventories and performance measures and to present some recent findings associated with hand preference and musculoskeletal disorders.     

Gender and carotid endarterectomy: does it matter?

Objective: Multiple large series have retrospectively identified female gender as a risk factor for perioperative stroke and death after carotid endarterectomy (CEA).Methods: Data for all patients who underwent CEA at a single institution from January 1990 to December 1998 were entered into a computerized vascular registry and form the basis of this report.Results: A total of 1298 CEA procedures were performed, of which 520 (40%) were in women and 778 (60%) in men. The mean age was 69.8 ± 8.7 years for men and 71.2 ± 8.5 years for women (P < .001). Cardiac risk factors significantly varied among the two groups, with women more likely to have diabetes (42% vs 36%) and hypertension (77% vs 66%), whereas tobacco history was higher among men (85% vs 71%) (P < .05 for all). Female patients were more likely to be asymptomatic at presentation (men, 44% vs women, 51%; P = .022). Postoperative myocardial infarction occurred in eight patients (0.6%) with no differences between men (0.4%) and women (1.0%) (P = not significant). For all adverse postoperative cardiac events (myocardial infarction, congestive heart failure, or arrhythmia), the incidence was 1.9% (25 patients), again with no differences between men (1.5%) and women (2.5%) (P = not significant). There were 25 postoperative neurologic events (19 strokes, six transient ischemic attacks) among the entire cohort (1.9%), of which 16 were in men (2.1%) and nine in women (1.6%; P = not significant). The overall postoperative stroke rate was 1.5% (13 [1.7%] of 778 men; 6 [1.2%;] of 520 women; P = not significant). Total operative mortality was 0.3% (3 [0.4%] of 778 men; 1 [0.2%] of 778 women; P = not significant). Late recurrent stenosis requiring operation developed in 14 patients (1.1%) during follow-up (6 [0.8%] of 778 men; 8 [1.5%] of 520 women; P = .19).Conclusions: Although there is significant variability in cardiac risk factors and presentation, female gender is not a risk factor for stroke, death, or cardiac morbidity after CEA. Women are not at higher risk for reoperation for recurrent stenosis.