Does partnership status affect the quality of life of men having robotic-assisted radical prostatectomy (RARP) for localised prostate cancer?

OBJECTIVE: To investigate whether there are any differences in prostate cancer-specific QoL measures at baseline and at 12-months post-surgery between partnered and unpartnered men having robot-assisted radical prostatectomy (RARP) for localised prostate cancer. METHODS: We investigated differences in patient-reported outcomes using the Expanded Prostate cancer Index Composite-26 (EPIC-26) and the Clark et al. Prostate Cancer Quality of Life Scales. RESULTS: Five hundred and forty patients were eligible for this study, 56 of whom were unpartnered. We found few differences between partnered and unpartnered men in terms of patient-reported quality of life outcomes following RARP. In our sample of patients with a high socio-economic status, partnered men had lower 12-month postoperative EPIC sexual domain scores and clinical T-stage and were more likely to be sexually active preoperatively. Overall, our data show that men having RARP for prostate cancer have low sexual confidence, high PSA concern and a low outlook at 12-months post-RARP, irrespective of partnership status. CONCLUSION: The findings of this study suggest that the RARP patient could benefit from a healthcare system that assesses patient sexual outcome following prostatectomy beyond potency and ability to penetrate a partner. By remaining cognisant of other domains such as sexual intimacy, sexual confidence, masculine self-esteem, health worry, PSA concern, outlook and treatment regret, nursing staff may be able to benefit the prostatectomy patient. Where deficits in these domains are observed by the nurse, referral for specialist psychological review could be made. Whether this could work to improve sexual outcomes in men following RARP deserves further investigation.

A prospective study of the short-term quality-of-life outcomes of patients undergoing transperineal prostate biopsy.

OBJECTIVE: To investigate in a prospective, observational study whether transperineal prostate biopsy (TPbx) results in patient-reported quality-of-life (QoL) changes from baseline in the first 3-months after TPbx. PATIENTS AND METHODS: Consenting patients completed the 26-item Expanded Prostate cancer Index Composite (EPIC-26), the Sexual Health Inventory for Men, the International Prostate Symptom Score, the Generalised Anxiety Disorder seven-item scale, the Patient Health Questionnaire nine-item scale, and a global question about willingness to have a repeat TPbx in a years' time. The instruments were scored using published scoring methods. Wilcoxon signed-rank tests and Mann-Whitney U-tests were used to investigate statistically significant differences. Clinically significant differences were also investigated defined by published minimal important differences for the EPIC-26 and changes in established categorical groups for the other instruments. RESULTS: In all, 53 patients consented to participate and completed the baseline questionnaire, in addition to at least one of the 1- or 3-month follow-up questionnaires. We found that most patients having a TPbx had no clinically significant change in QoL in the first 3 months after TPbx. However, 24% had clinically worse urinary function and 18% had worse sexual function at 1 month. At 3 months, 3% of patients had clinically worse urinary function and 25% continued to have worse sexual function compared with baseline. Patients who were subsequently diagnosed with cancer based on the results of the TPbx, had statistically significantly reduced QoL for the EPIC-26 urinary scales and reduced improvements in scores on the psychological scales at the 1-month follow-up compared with those who were not diagnosed with cancer. CONCLUSIONS: Most patients having a TPbx had no clinically significant change in QoL in the first 3 months after TPbx. However, patients should be advised that a quarter may have clinically worse urinary function and nearly 20% have clinically worse sexual function in the first month, and that sexual function deficits may continue up to 3 months. The results of this study provide a resource that the clinician can use when discussing TPbx with patients.

Practical research methods for orthopaedic surgeons.

Inherent to understanding an orthopaedic study is a fundamental knowledge of the study's design principles and statistics. Statistics, in part, allow a researcher to sample a portion of the population and use probability to decide whether the findings from the sample are likely to apply to the whole population. Although statistical jargon can be confusing, several simple principles guide the approach to research design. It is helpful for orthopaedic surgeons to review different study designs and their levels of evidence, to understand statistical jargon and the selection of the statistical test that is appropriate for given types of data, and to be familiar with the process of sample size calculations. Knowledge gained from statistical principles and research design is used to interpret study results. Such knowledge is invaluable for judging the value of new clinical evidence and for designing future studies.

Measuring diaphragm movement and respiratory frequency using a novel ultrasound device in healthy volunteers.

PURPOSE: To evaluate the ability of a novel ultrasound (US) device, DiaMon, to monitor diaphragm movement via its proxy liver movement, and compare it with the respired flow measured with a flowmeter, in awake and healthy volunteers. We wanted to (1) establish the optimal anatomical position for attaching the DiaMon device to the abdominal wall, and (2) evaluate the accuracy of continuous monitoring of respiratory frequency. METHODS: Thirty healthy subjects were recruited. The DiaMon probe was applied subcostally in four different positions with the subjects in five different postures. The subjects breathed tidal volumes into a spirometer for 30-60 s with the DiaMon recording simultaneously. RESULTS: The device detected a readable signal in 83-100% of the position/posture-combinations. The technical correlation between the two signals was highest in the anterior axillary-supine position (mean ± SD: 0.95 ± 0.03), followed by paramidline-supine (0.90 ± 0.09) and midclavicular-supine (0.89 ± 0.12). The frequency measurements yielded a mean difference of 0.03 (95% limits of agreement - 0.11, 0.16) breaths per minute in the anterior axillary-supine position. CONCLUSION: The DiaMon device is able to detect liver movement in most subjects, and it measures breathing frequency accurately.

Novel measures of cardiovascular health and its association with prevalence and progression of age-related macular degeneration: the CHARM Study.

BACKGROUND: To determine if novel measures of cardiovascular health are associated with prevalence or progression of age-related macular degeneration (AMD). METHODS: Measures of the cardiovascular system: included intima media thickness (IMT), pulse wave velocity (PWV), systemic arterial compliance (SAC), carotid augmentation index (AI). For the prevalence study, hospital-based AMD cases and population-based age- and gender-matched controls with no signs of AMD in either eye were enrolled. For the progression component, participants with early AMD were recruited from two previous studies; cases were defined as progression in one or both eyes and controls were defined as no progression in either eye. RESULTS: 160 cases and 160 controls were included in the prevalence component. The upper two quartiles of SAC, implying good cardiovascular health, were significantly associated with increased risk of AMD (OR = 2.54, 95% CL = 1.29, 4.99). High PWV was associated with increased prevalent AMD. Progression was observed in 82 (32.3%) of the 254 subjects recruited for the progression component. Higher AI (worse cardiovascular function) was protective for AMD progression (OR = 0.30, 95%CL = 0.13, 0.69). Higher aortic PWV was associated with increased risk of AMD progression; the highest risk was seen with the second lowest velocity (OR = 6.22, 95% CL = 2.35, 16.46). CONCLUSION: The results were unexpected in that better cardiovascular health was associated with increased risk of prevalent AMD and progression. Inconsistent findings between the prevalence and progression components could be due to truly different disease etiologies or to spurious findings, as can occur with inherent biases in case control studies of prevalence. Further investigation of these non-invasive methods of characterizing the cardiovascular system should be undertaken as they may help to further elucidate the role of the cardiovascular system in the etiology of prevalent AMD and progression.

"We Used a Validated Questionnaire": What Does This Mean and Is It an Accurate Statement in Urologic Research?

OBJECTIVE: To educate a clinical audience of what the specific meaning of the term "validated questionnaire" means from a research methodology perspective when used in a journal article or a conference presentation. METHODS: To emphasize what is meant by the term "validated questionnaire," we reviewed the most commonly used prostate-specific, patient-reported, outcome assessment instruments and discuss which have been appropriately validated for use in patients having surgery for localized prostate cancer. RESULTS: Not all the prostate-specific instruments used to assess outcomes after surgical treatment for localized prostate cancer have been validated for use in this population. In particular, the Sexual Health Inventory for Men and the International Prostate Symptom Score-American Urological Association-7, which are commonly used by clinicians to measure potency and urinary function, respectively, have not been validated for use in a population of patients having surgery for localized prostate cancer. CONCLUSION: Although patient-reported outcome assessment instruments are frequently used in the urologic literature, little consideration has been given to ensure that users understand why a questionnaire must be validated and what the term "validated" actually means from a research methodology perspective when used in this context. Whether an instrument displays appropriate measurement properties is not a fixed attribute but is dependent on the context and population being studied. Studies using questionnaires that have not been validated in the population of interest may be subject to measurement error, and any conclusions drawn cannot be made with total confidence. Clinicians should consider this when reading journal articles and designing study protocols.

A description of the severity of equestrian-related injuries (ERIs) using clinical parameters and patient-reported outcomes.

INTRODUCTION: Despite a number of injury prevention campaigns and interventions, horse riding continues to be a dangerous activity, resulting in more accidents per hour than motorcycling, skiing and football. Injuries are often serious, with one in four patients requiring admission to hospital. This study aims to describe the severity of equestrian-related injuries (ERIs) using both clinical parameters and patient-reported outcomes. PATIENTS AND METHODS: A retrospective study of all patients aged ≥18 years admitted to The Alfred Hospital between January 2003 and January 2008 with an ERI was performed. Specific clinical data were extracted from the medical record. In addition, a questionnaire was conducted identifying the details of the accident, the required recovery time and levels of ongoing pain and physical disability. RESULTS: During the study period 172 patients met the inclusion criteria. There were three deaths (2%). Eighty-two patients (48%) suffered head injuries. Forty-one patients (24%) were admitted to the ICU and 31 patients (18%) required mechanical ventilation. On discharge, 41 patients (24%) required transfer to a sub-acute rehabilitation facility. One-hundred-and-twenty-four patients (72%) completed the questionnaire. Thirty-nine respondents (31%) were not wearing a helmet. Among patients injured for more than 6 months, 38 (35%) still experienced moderate or severe pain or disability. Ninety-five patients had returned to work at the time of review, among which 47(50%) required longer than 6 months to recover, and 40 (42%) returned at a reduced capacity. CONCLUSIONS: The clinical and patient-reported outcomes of ERIs requiring hospital admission are poor. Persistent pain and disability are common, even up to 5 years post-injury. A large proportion of patients required longer than 6 months to return to work and many return at a reduced capacity.

Surgical strategies in polytraumatized patients with femoral shaft fractures - comparing a German and an Australian level I trauma centre.

BACKGROUND: Femoral shaft fractures are one of the most common injuries in multiple trauma patients. Due to their prognostic relevance, there is an ongoing controversial discussion as to the optimal treatment strategy in terms of Damage Control Orthopaedics (DCO) and Early Total Care (ETC). We aimed to describe the differences in fracture management and clinical outcome of multiple trauma patients with concomitant femoral shaft fractures treated at a German and an Australian level I trauma centre using the same inclusion criteria. METHODS: Polytraumatized patients (ISS ≥ 16) with a femoral shaft fracture aged ≥ 16 years treated at a German and an Australian trauma centre between 2003 and 2007 were included. According to ETC and DCO management principles, we evaluated demographic parameters as well as posttraumatic complications and clinical outcome. RESULTS: Seventy-three patients were treated at the German and 134 patients at the Australian trauma centre. DCO was performed in case of increased injury severity in both hospitals. Prolonged mechanical ventilation time, and length of ICU and hospital stay were demonstrated in DCO treatment regardless of the trauma centre. No differences concerning posttraumatic complications and survival were found between both centres. Survival of patients after DCO was similar to those managed using ETC despite a greater severity of injury and lower probability of survival. There was no difference in the incidence of ARDS. DCO was, however, associated with a greatly increased length of time on mechanical ventilation and length of stay in the ICU. CONCLUSION: We found no differences concerning patient demographics or clinical outcomes in terms of incidence of ARDS, MODS, or mortality. As such, we propose that comparability between German and Australian trauma populations is justified. Despite a higher ISS in the DCO group, there were no differences in posttraumatic complications and survival depending on ETC or DCO treatment. Further research is required to confirm whether this is the case with other countries, too.

Ethical issues in the design of randomized trials: to sham or not to sham.

The placebo effect is based on the expectations of the patient regarding the effectiveness of the treatment. The high levels of stress and rituals involved with surgery can lead to a strong placebo effect. However, the ethical principles of performing sham surgery to measure any placebo effect have been questioned, and sham-controlled surgical trials are rarely conducted. While there are a number of ethical principles that must be considered to justify the implementation of a sham-controlled surgical clinical trial, four areas deserve particular attention: equipoise, risk minimization, informed consent, and deception. Particularly in orthopaedics, where equipoise is common, sham-controlled trials may be important to ensure that inferior or ineffective treatments do not become standard practice.

Nutritional status and short-term outcome of hip arthroplasty.

PURPOSE: To review nutritional status and outcome of 90 patients who underwent total hip arthroplasty (THA) or hemiarthroplasty. METHODS: Records of 51 women and 39 men aged 26 to 96 (median, 71) years who underwent elective THA (n=48) for osteoarthritis, or trauma-related THA (n=10) or hemiarthroplasty (n=32) for subcapital femoral neck fractures using an uncemented femoral stem were retrospectively reviewed. Patient demographics and intra- and post-operative complications were recorded. Patient co-morbidities were assessed according to the Charlson grading system. Nutritional status was assessed using haematological markers of serum albumin (ALB) level and total lymphocyte count (TLC). Samples were taken on the day of the operation and within 24 hours of operation. Suboptimal nutrition was defined as a serum ALB level of <3.5 g/dl and a TLC of <1.50 cells/mm. RESULTS: 86% of trauma patients and 30% of elective patients were malnourished preoperatively (p<0.001). Preoperatively, more males than females had suboptimal ALB levels (28% vs. 8%, p=0.033) and TLC (82% vs. 31%, p<0.001). Age was inversely proportional to preoperative ALB and TLC values; patients older than 75 years had significantly lower values. Of those staying >7 days in hospital, 67% were aged >75 years as opposed to 31% were aged ≤ 75 years (p=0.001). Male gender, old age, and presentation with trauma were risk factors for suboptimal nutritional parameters (p<0.001 for all). Patients with suboptimal ALB and TLC values had a significantly longer stay in hospital (p=0.032 and p=0.021, respectively). CONCLUSION: The rate of malnourishment was significantly higher in patients having trauma-related surgery than in those having elective surgery. Malnourished patients are at greater risk of prolonged hospital stay. Preoperative nutritional assessment may be useful in predicting patients at high surgical risk.

Pulmonary embolism and the use of vena cava filters after major trauma.

BACKGROUND: Major trauma patients are at significant risk of developing pulmonary embolism (PE). We aimed to (i) analyse the current incidence and timing of PE after injury; (ii) identify risk factors that predispose major trauma patients to the occurrence of PE; and (iii) describe the use of vena cava filters (VCFs) following major trauma. METHODS: Prospectively collected data from The Alfred Hospital's Trauma Registry were used to identify all major trauma patients admitted over a 7-year period. A multivariable logistic regression model was used to identify factors associated with the occurrence of PE. A similar model was developed to identify factors associated with the use of VCFs inserted at the discretion of the treating clinician. RESULTS: A total of 6344 major trauma patients were treated during this period, with 73.2% male, mean age of 44.2, 90.2% with a blunt mechanism of injury and mean injury severity score of 24.3. Prophylactic VCFs were inserted in 511 patients (8.1%), with a mean time to insertion of 3.6 days after injury. There were 45 PE, 2 of which were fatal. The mean time to PE was 12 days post-injury. Three variables were independently associated with the occurrence of PE: the absence of a VCF; number of injuries to the lower limb; and central venous catheterization. CONCLUSION: The PE rate was 0.71%. Lower limb injuries and central venous catheterization are independently associated with a higher risk of PE after major trauma and VCFs are associated with a reduced risk.

Risk factors for non-union in the non-operative management of type II dens fractures.

BACKGROUND: Despite the publication of numerous studies, there remains controversy regarding the non-operative treatment of type II dens fractures. The halo-thoracic vest (HTV) and rigid cervical collar are the most commonly used. We sought to compare the outcomes of patients managed with these devices in terms of risk factors for non-union and complication rates. METHODS: This study was a retrospective review of adult patients with type II dens fractures treated non-operatively at a Level 1 Trauma Centre between 2001 and 2007. Patient medical records and imaging studies were reviewed. Union was defined as stable fibrous union or bony union at 3 months. RESULTS: Sixty-seven patients were included ­ 35 treated using a HTV and 32 with a collar. Non-union was associated with increased time in HTV or collar (P = 0.011), a mechanism of injury involving a low fall (P = 0.008), or low velocity injuries (P = 0.04). The proportion of patients with stable union at 3 months was 60% for the HTV group versus 35% for the cervical collar group (P = 0.10). There were trends to support increased risk of non-union with age ≥65 years (P = 0.13) or with fracture displacement ≥2 mm (P = 0.17) at the time of presentation. Clinically significant complications of the HTV were more common than those experienced with collar. Of HTV patients, 60% suffered one or more complications compared with 6% for collar. CONCLUSIONS: We were unable to demonstrate any statistically significant advantage or disadvantage of either device. Further investigation of mortality and morbidity would be beneficial.

Alendronate-associated femoral insufficiency fractures and femoral stress reactions.

PURPOSE: To report characteristics and outcomes of 8 patients who underwent intramedullary nailing for alendronate-associated femoral insufficiency fractures. METHODS: Records of 7 women and one man aged 54 to 91 (mean, 72) years who underwent intramedullary nailing for spontaneous or low-energy, alendronateassociated femoral insufficiency fractures were retrospectively reviewed. Contralateral femurs were assessed for stress reactions. RESULTS: All patients had at least 4 (range, 4-10) years of alendronate use. Five patients had experienced prodromal pain lasting one day to 5 months. Five patients had received concurrent glucocorticoid therapy. At the 6-month follow-up, 6 patients had bony union, one had hypertrophic non-union and underwent dynamisation and nail exchange and eventually achieved union at month 16, and one had fixation loss and underwent nail exchange and bone grafting and eventually achieved union at month 9. In 3 patients, the contralateral femurs were painful, and cortical stress reactions were noted. They underwent prophylactic intramedullary nailing. Radiographs showed no evidence of new stress reactions or fractures. CONCLUSION: Contralateral involvement in patients with alendronate-associated femoral insufficiency fractures is not uncommon. Early prophylactic intramedullary nailing may provide effective pain relief and prevent progression to a fracture.

Post-operative numbness and patient satisfaction following plate fixation of clavicular fractures.

INTRODUCTION AND AIM: Numbness across the shoulder and upper chest wall is a frequent complication following plate fixation of clavicular shaft fractures. This is usually attributed to damage to branches of the supraclavicular nerve caused by the surgical approach. We investigate whether the use of an incision perpendicular to the long axis of the clavicle (vertical incision) rather than one parallel to it (horizontal incision) is associated with reduced post-operative numbness and improved patient satisfaction. METHODS: We retrospectively assessed a group of patients who underwent plate fixation of a fractured clavicle at our institution. Using a patient-completed questionnaire, we compared differences in numbness, scar satisfaction, pain, and overall satisfaction with the operation, between those who received a horizontal incision (n=21) versus those treated using a vertical incision (n=14). RESULTS: The likelihood of experiencing post-operative numbness was less in the vertical incision group. Those who had undergone vertical incisions also reported a significantly reduced degree of numbness and significantly less awareness of the numbness with clothing and shoulder straps. There was no statistically significant difference between the groups in terms of pain and scar satisfaction. Patients who reported being most bothered by their numbness also tended to report the highest dissatisfaction with the operation. CONCLUSION: Vertical incisions for plate fixation of clavicular shaft fractures may be associated with reduced post-operative numbness and avoid some cases of patient dissatisfaction. Surgeons should consider using this approach in plate fixation of clavicle fractures.

A comparison of self-reported and independently observed disability in an orthopedic trauma population.

BACKGROUND: Although outcome measures that assess disability after isolated orthopedic injuries have been found to be valid and responsive to change, the reliability of self-reported disability has not been studied in these patients. The purpose of this study was to compare self-reported and independently observed disability in patients with isolated orthopedic injuries. METHODS: Items were selected from the Short Musculoskeletal Functional Assessment (SMFA) and Disabilities of the Arm, Shoulder, and Hand (DASH) outcome assessment instruments. Participants had either an isolated upper (n = 61) or lower extremity (n = 55) injury or were noninjured controls (n = 40). Participants completed the SMFA and DASH before being videotaped completing items selected from the outcome assessment instruments. Observers reviewed the video and rated participants' levels of disability in performing the items. RESULTS: Observers consistently rated the disability levels for the items lower than the participants. Overall, agreement in levels of disability between observers and participants varied greatly across the different items (quadratic weighted kappa; range, 0.00-0.82). CONCLUSION: The results emphasize that patients and observers differ in their assessment of an individual's level of disability in performing items related to activities of daily living. Therefore, caution should be used when data collected by a proxy observer is used to substitute self-reported data.

Does the presence of an upper extremity injury affect outcomes after major trauma?

BACKGROUND: There is a paucity of information about the impact of upper extremity (UE) injuries on patient outcomes, particularly after major trauma. METHODS: Data were obtained from a statewide trauma registry. Cases were defined as major trauma cases (Injury Severity Score > 15) with (UE group) and without (no-UE group) an associated upper extremity injury. Multivariate analysis was performed to identify independent predictors of outcome. RESULTS: Major trauma patients with UE injury were 1.5 times (p = 0.011) more likely than the no-UE group to have a length of stay greater than 7 days. After adjusting for age, mechanism of injury, and Injury Severity Score, UE injury was not an independent predictor of discharge destination. CONCLUSION: In major trauma patients, the presence of an upper extremity injury is a significant predictor of length of stay, indicating a greater complexity and cost of care associated with this group of major trauma patients.

Outcome instruments for the assessment of the upper extremity following trauma: a review.

Orthopaedic injuries are common among trauma patients and can result in long-term problems. Considerable data are available regarding functional outcomes following lower extremity trauma. There is, however, a paucity of data available for upper extremity trauma patients. Whilst currently available instruments appear to assess outcomes of relevance in trauma populations, the reliability, validity and responsiveness of these instruments have not been evaluated in the upper extremity trauma population. This paper reviews instruments designed for patient self-evaluation of musculoskeletal disorders of the upper extremity, and instruments used in an orthopaedic trauma population to assess functional recovery following injury. The Musculoskeletal Functional Assessment (MFA), Short Musculoskeletal Functional Assessment (SMFA), Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons Shoulder Scale (ASES-s), American Shoulder and Elbow Surgeons Elbow Scale (ASES-e), Patient Rated Elbow Evaluation (PREE), and the Patient Rated Wrist Evaluation (PRWE) were reviewed. Until research is published outlining the evaluation of assessment instruments in upper extremity orthopaedic populations, authors will need to conduct their own validation studies before investigating outcomes in specific trauma populations.

Choosing outcome assessment instruments for trauma registries.

While trauma registries have the potential to collect detailed information about patient outcomes, the most commonly reported outcome, mortality, only represents the outcome from a small proportion of the total trauma population. If trauma registries are to progress to routine monitoring of outcomes in trauma survivors, instruments that measure relevant outcomes in the remainder of the trauma population must be identified and implemented. This report provides an overview of the specific needs of trauma registries with respect to assessing patient outcomes other than mortality. The use of previously recommended outcome assessment instruments is discussed, with a focus on the utility of these instruments for use in routine monitoring of trauma outcomes other than mortality through trauma registries.