Rajat Mittal

CONSORT compliance in surgical randomized trials: are we there yet? A systematic review.

Objective: We performed a systematic review assessing the reporting quality of trials of surgical interventions, and explored associated trial level variables. Background: Randomized controlled trials (RCTs) provide clinicians with the best evidence for the effects of interventions, but may not be reported with necessary detail. Methods: In May 2009, 3 databases (MEDLINE, EMBASE, and CENTRAL) were searched for RCTs that assessed a surgical intervention using a comprehensive electronic strategy developed by the Cochrane Collaboration. The Consolidated Standards of Reporting Trials (CONSORT) checklist was used as a measure of reporting quality. An overall CONSORT score was calculated and expressed as a proportion. This was supplemented with domains related to external validity. We also collected data on characteristics hypothesized to improve reporting quality, and exploratory regression was performed to determine associations. Results: One hundred fifty recently published RCTs were included. The most commonly represented surgical subspecialties were general (29%), orthopedic (23%), and cardiothoracic (13%). Most (65%) were published in subspecialty surgical journals. Overall reporting quality was low, with only 55% of CONSORT items addressed. Less than half of trials described adequate methods for sample size calculation (45%), random sequence generation (43%), allocation concealment (45%), and blinding (37%). The strongest associations with reporting quality were adequate methods related to methodological domains, an author with an epidemiology/statistics degree, and a longer report length. Conclusions: There remains much room for improvement for the reporting of surgical intervention trials. Authors and journal editors should apply existing reporting guidelines, and guidelines specific to the reporting of surgical interventions should be developed.

One-to-One Therapy Is Not Superior to Group or Home-Based Therapy After Total Knee Arthroplasty A Randomized, Superiority Trial

BACKGROUND The aim of this study was to determine whether center-based, one-to-one physical therapy provides superior outcomes compared with group-based therapy or a simple monitored home-based program in terms of functional and physical recovery and health-related quality of life after total knee arthroplasty. METHODS Patients awaiting primary total knee arthroplasty at two Sydney metropolitan hospitals were enrolled into this prospective, randomized, superiority trial preoperatively. At two weeks postoperatively, participants were randomly allocated to one of three six-week treatment programs (twelve one-to-one therapy sessions, twelve group-based therapy sessions, or a monitored home program) with use of a computer-generated sequence. Self-reported outcomes (Oxford Knee Score, Western Ontario and McMaster Universities Osteoarthritis Index pain and function subscales, and Medical Outcomes Study 12-Item Short-Form Survey) and performance-based functional outcomes were measured over twelve months postoperatively by a blinded assessor. The primary outcome was knee pain and function measured with use of the Oxford Knee Score at ten weeks postoperatively. Intention-to-treat analysis was conducted. RESULTS Two hundred and forty-nine patients (eighty-five who had one-to-one therapy, eighty-four who had group-based therapy, and eighty who were in the monitored home program) were randomized and 233 were available for their one-year follow-up assessment. Participants who received one-to-one therapy did not have a superior Oxford Knee Score at week ten compared with those who received the alternative interventions; the median score was 32 points for the one-to-one therapy group, 36 points for the group-based therapy group, and 34 points for the monitored home program group (p = 0.20). Furthermore, one-to-one therapy was not superior compared with group-based therapy or monitored home program in improving any of the secondary outcomes across the first postoperative year. No adverse events were associated with any of the treatment arms. CONCLUSIONS One-to-one therapy does not provide superior self-reported or performance-based outcomes compared with group-based therapy or a monitored home program, in the short term and the long term after total knee arthroplasty. LEVEL OF EVIDENCE Therapeutic level I. See Instructions for Authors for a complete description of levels of evidence.

Discordance Between Patient and Surgeon Satisfaction After Total Joint Arthroplasty

We surveyed 331 patients undergoing total hip or knee arthroplasty pre-operatively, and patients and surgeons were both surveyed 6 and 12 months post-operatively. We identified variables (demographic factors, operative factors and patient expectations) as possible predictors for discordance in patient-surgeon satisfaction. At 12 months, 94.5% of surgeons and 90.3% of patients recorded satisfaction with the outcome. The discordance between patient and surgeon satisfaction was mainly due to patient dissatisfaction-surgeon satisfaction. In an adjusted analysis, the strongest predictors of discordance in patient-surgeon satisfaction were unmet patient expectations and the presence of complications. Advice to potential joint arthroplasty candidates regarding the decision to proceed with surgery should be informed by patient reported outcomes, rather than the surgeons opinion of the likelihood of success.

Trends in knee arthroscopy and subsequent arthroplasty in an Australian population: a retrospective cohort study.

BackgroundKnee arthroscopy is a common procedure in orthopaedic surgery. In recent times the efficacy of this procedure has been questioned with a number of randomized controlled trials demonstrating a lack of effect in the treatment of osteoarthritis. Consequently, a number of trend studies have been conducted, exploring rates of knee arthroscopy and subsequent conversion to Total Knee Arthroplasty (TKA) with varying results. Progression to TKA is seen as an indicator of lack of effect of primary knee arthroscopy.The aim of this paper is to measure overall rates of knee arthroscopy and the proportion of these patients that undergo subsequent total knee arthroplasty (TKA) within 24 months, and to measure trends over time in an Australian population.MethodsWe conducted a retrospective cohort study of all adults undergoing a knee arthroscopy and TKA in all hospitals in New South Wales (NSW), Australia between 2000 and 2008. Datasets obtained from the Centre for Health Record Linkage (CHeReL) were analysed using negative binomial regression. Admission rates for knee arthroscopy were determined by year, age, gender and hospital status (public versus private) and readmission for TKA within 24 months was calculated.ResultsThere was no significant change in the overall rate of knee arthroscopy between 2000 and 2008 (-0.68%, 95% CI: -2.80 to 1.49). The rates declined in public hospitals (-1.25%, 95% CI: -2.39 to -0.10) and remained relatively steady in private hospitals (0.42%, 95% CI: -1.43 to 0.60). The proportion of patients 65 years or over undergoing TKA within 24 months of knee arthroscopy was 21.5%. After adjusting for age and gender, there was a significant decline in rates of TKA within 24 months of knee arthroscopy for all patients (-1.70%, 95% CI:-3.13 to -0.24), patients admitted to private hospitals (-2.65%, 95% CI: -4.06 to -1.23) and patients aged ≥65 years (-3.12%, 95% CI: -5.02 to -1.18).ConclusionsRates of knee arthroscopy are not increasing, and the proportion of patients requiring a TKA within 24 months of a knee replacement is decreasing in the age group most likely to have degenerative changes in the knee.

Is discharge knee range of motion a useful and relevant clinical indicator after total knee replacement? Part 2.

OBJECTIVE Knee range of motion (ROM) at discharge from acute care is used as a clinical indicator following total knee replacement (TKR) surgery. This study aimed to assess the clinical relevance of this indicator by determining whether discharge knee ROM predicts longer-term knee ROM and patient-reported knee pain and function. METHODS A total of 176 TKR recipients were prospectively followed after discharge from acute care. Outcomes assessed included knee ROM and Oxford knee score post rehabilitation and 1 year post surgery. Discharge ROM and other patient factors were identified a priori as potential predictors in multiple linear regression modelling. RESULTS A total of 133 (76%) and 141 (80%) patients were available for follow-up post rehabilitation [mean postoperative week 8.1 (SD 2.7)] and at 1 year [mean postoperative month 12.1 (SD 1.4)], respectively. Greater discharge knee flexion was a significant (P < 0.001) predictor of greater post-rehabilitation flexion but not 1-year knee flexion (P < 0.083). Better discharge knee extension was a significant predictor of better post-rehabilitation (P = 0.001) and 1-year knee extension (P = 0.013). Preoperative Oxford score and post-rehabilitation knee flexion independently predicted post-rehabilitation Oxford score, and gender predicted 1-year Oxford score. Discharge ROM did not significantly predict Oxford score in either model. CONCLUSION The finding that early knee range predicts longer-term range provides clinical evidence favouring the relevance of discharge knee ROM as a clinical indicator. Although longer-term patient-reported knee pain and function were not directly associated with discharge knee ROM, they were associated with ROM when measured concurrently in the sub-acute phase. No causal effect has been demonstrated, but the findings suggest it may be important for physiotherapists to maximize range in the early and sub-acute periods.

Tourniquet application only during cement fixation in total knee arthroplasty: a double-blind, randomized controlled trial

Background:  The functional benefits of tourniquet application for short periods compared with standard duration applications during total knee arthroplasty surgery have not been well explored. We aimed to compare functional outcomes between tourniquet application of short duration (during cement fixation only) and tourniquet application of longer duration (from skin incision to just after cement fixation).

Evidence‐based review for patients undergoing elective hip and knee replacement

The objective of this study was to evaluate the evidence for different interventions in the preoperative, perioperative and post‐operative care for people undergoing elective total hip (THR) and knee (TKR) replacement surgery.

Satisfaction with joint replacement in public versus private hospitals: a cohort study.

Introduction:  In Australia, the majority of total knee and hip replacement surgeries occur in the private sector. Outcome‐based research needs to be inclusive of this sector if the findings are intended to reflect the broader picture. This study compares outcomes up to 1 year post knee and hip replacement between patients treated in the public and private sectors.

Review Article: Total hip replacement in haemodialysis or renal transplant patients

25 studies involving 755 hips in 534 patients were reviewed to determine the complication rates of total hip replacement in haemodialysis or renal transplant patients. In comparison of both groups, renal transplant patients were generally younger and more likely to receive an uncemented implant, whereas haemodialysis patients had approximately twice the infection rate and higher rates of mortality, revision, aseptic loosening, and hip dislocation. Both groups had increased complication rates, compared with patients without renal failure.

Introductory insights into patient preferences for outpatient rehabilitation after knee replacement: implications for practice and future research

OBJECTIVES Current perspectives concerning clinical decision making favour inclusion of patient preference for therapy. This exploratory study aimed to forge introductory insights into patient preference for outpatient-based rehabilitation after total knee replacement (TKR). METHODS TKR recipients from six public hospitals participating in a prospective, longitudinal study assessing outcomes after surgery were surveyed 1 year after surgery about preferences for rehabilitation. Surveys were conducted face-to-face or via postal questionnaire. Questions included global satisfaction (percentage scale) with therapy received, future preference for therapy and the reasons underpinning preference. RESULTS Ninety-three (93/115) TKR recipients participated [mean age 68 (SD 8) years; 66% female; 75% face-to-face interview]. Group-based (39/93) and one-to-one therapies (38/93) were the most common modes experienced. Most participants (81/93) were highly satisfied (satisfaction ≥ 75%). Future preference was associated with satisfaction with past exposure regardless of mode (P = 0.02), hence no overall preference for one mode emerged. Commonality existed in the reasons why patients preferred specific modes. The most common reason for preferring group-based therapy was psychosocial benefit whilst the more personalized approach was the most common reason for preferring one-to-one therapy. CONCLUSIONS Patient global satisfaction is similarly high across different modes of outpatient rehabilitation despite differences in perceived benefits. The association between satisfaction and preference potentially indicates that provided the service is deemed high quality, the actual mode of therapy offered is less important to this patient population. Research is required, however, to establish the relationship between preference and outcome, the stability of preference across time, and the effect of multiple rehabilitation exposures on preference. For now, the quality of current uni-modal programmes could be enhanced by incorporation of features typically associated with alternative modes.