Yaping Chang

Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis

Objective To examine the effect of transcatheter aortic valve implantation (TAVI) versus surgical replacement of an aortic valve (SAVR) in patients with severe aortic stenosis at low and intermediate risk of perioperative death. Design Systematic review and meta-analysis Data sources Medline, Embase, and Cochrane CENTRAL. Study selection Randomized trials of TAVI compared with SAVR in patients with a mean perioperative risk of death <8%. Review methods Two reviewers independently extracted data and assessed risk of bias for outcomes important to patients that were selected a priori by a parallel guideline committee, including patient advisors. We used the GRADE system was used to quantify absolute effects and quality of evidence. Results 4 trials with 3179 patients and a median follow-up of two years were included. Compared with SAVR, transfemoral TAVI was associated with reduced mortality (risk difference per 1000 patients: −30, 95% confidence interval −49 to −8, moderate certainty), stroke (−20, −37 to 1, moderate certainty), life threatening bleeding (−252, −293 to −190, high certainty), atrial fibrillation (−178, −150 to −203, moderate certainty), and acute kidney injury (−53, −39 to −62, high certainty) but increased short term aortic valve reintervention (7, 1 to 21, moderate certainty), permanent pacemaker insertion (134, 16 to 382, moderate certainty), and moderate or severe symptoms of heart failure (18, 5 to 34, moderate certainty). Compared with SAVR, transapical TAVI was associated higher mortality (57, −16 to 153, moderate certainty, P=0.015 for interaction between transfemoral versus transapical TAVI) and stroke (45, −2 to 125, moderate certainty, interaction P=0.012). No study reported long term follow-up, which is particularly important for structural valve deterioration. Conclusions Many patients, particularly those who have a shorter life expectancy or place a lower value on the risk of long term valve degeneration, are likely to perceive net benefit with transfemoral TAVI versus SAVR. SAVR, however, performs better than transapical TAVI, which is of interest to patients who are not candidates for transfemoral TAVI. Systematic review registration PROSPERO CRD42016042879

Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies

Objective To determine the frequency of survival, stroke, atrial fibrillation, structural valve deterioration, and length of hospital stay after surgical replacement of an aortic valve (SAVR) with a bioprosthetic valve in patients with severe symptomatic aortic stenosis. Design Systematic review and meta-analysis of observational studies. Data sources Medline, Embase, PubMed (non-Medline records only), Cochrane Database of Systematic Reviews, and Cochrane CENTRAL from 2002 to June 2016. Study selection Eligible observational studies followed patients after SAVR with a bioprosthetic valve for at least two years. Methods Reviewers, independently and in duplicate, evaluated study eligibility, extracted data, and assessed risk of bias for patient important outcomes. We used the GRADE system to quantify absolute effects and quality of evidence. Published survival curves provided data for survival and freedom from structural valve deterioration, and random effect models provided the framework for estimates of pooled incidence rates of stroke, atrial fibrillation, and length of hospital stay. Results In patients undergoing SAVR with a bioprosthetic valve, median survival was 16 years in those aged 65 or less, 12 years in those aged 65 to 75, seven years in those aged 75 to 85, and six years in those aged more than 85. The incidence rate of stroke was 0.25 per 100 patient years (95% confidence interval 0.06 to 0.54) and atrial fibrillation 2.90 per 100 patient years (1.78 to 4.79). Post-SAVR, freedom from structural valve deterioration was 94.0% at 10 years, 81.7% at 15 years, and 52% at 20 years, and mean length of hospital stay was 12 days (95% confidence interval 9 to 15). Conclusion Patients with severe symptomatic aortic stenosis undergoing SAVR with a bioprosthetic valve can expect only slightly lower survival than those without aortic stenosis, and a low incidence of stroke and, up to 10 years, of structural valve deterioration. The rate of deterioration increases rapidly after 10 years, and particularly after 15 years.

Knee arthroscopy versus conservative management in patients with degenerative knee disease: a systematic review

Objective To determine the effects and complications of arthroscopic surgery compared with conservative management strategies in patients with degenerative knee disease. Design Systematic review. Main outcome measures Pain, function, adverse events. Data sources MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar and Open Grey up to August 2016. Eligibility criteria For effects, randomised clinical trials (RCTs) comparing arthroscopic surgery with a conservative management strategy (including sham surgery) in patients with degenerative knee disease. For complications, RCTs and observational studies. Review methods Two reviewers independently extracted data and assessed risk of bias for patient-important outcomes. A parallel guideline committee (BMJ Rapid Recommendations) provided input on the design and interpretation of the systematic review, including selection of patient-important outcomes. We used the GRADE approach to rate the certainty (quality) of the evidence. Results We included 13 RCTs and 12 observational studies. With respect to pain, the review identified high-certainty evidence that knee arthroscopy results in a very small reduction in pain up to 3 months (mean difference =5.4 on a 100-point scale, 95% CI 2.0 to 8.8) and very small or no pain reduction up to 2 years (mean difference =3.1, 95% CI −0.2 to 6.4) when compared with conservative management. With respect to function, the review identified moderate-certainty evidence that knee arthroscopy results in a very small improvement in the short term (mean difference =4.9 on a 100-point scale, 95% CI 1.5 to 8.4) and very small or no improved function up to 2 years (mean difference =3.2, 95% CI −0.5 to 6.8). Alternative presentations of magnitude of effect, and associated sensitivity analyses, were consistent with the findings of the primary analysis. Low-quality evidence suggested a very low probability of serious complications after knee arthroscopy. Conclusions Over the long term, patients who undergo knee arthroscopy versus those who receive conservative management strategies do not have important benefits in pain or function. Trial registration number PROSPERO CRD42016046242.

Predictors of persistent pain after breast cancer surgery: a systematic review and meta-analysis of observational studies

Background: Persistent pain after breast cancer surgery affects up to 60% of patients. Early identification of those at higher risk could help inform optimal management. We conducted a systematic review and meta-analysis of observational studies to explore factors associated with persistent pain among women who have undergone surgery for breast cancer. Methods: We searched the MEDLINE, Embase, CINAHL and PsycINFO databases from inception to Mar. 12, 2015, to identify cohort or case–control studies that explored the association between risk factors and persistent pain (lasting ≥ 2 mo) after breast cancer surgery. We pooled estimates of association using random-effects models, when possible, for all independent variables reported by more than 1 study. We reported relative measures of association as pooled odds ratios (ORs) and absolute measures of association as the absolute risk increase. Results: Thirty studies, involving a total of 19 813 patients, reported the association of 77 independent variables with persistent pain. High-quality evidence showed increased odds of persistent pain with younger age (OR for every 10-yr decrement 1.36, 95% confidence interval [CI] 1.24–1.48), radiotherapy (OR 1.35, 95% CI 1.16–1.57), axillary lymph node dissection (OR 2.41, 95% CI 1.73–3.35) and greater acute postoperative pain (OR for every 1 cm on a 10-cm visual analogue scale 1.16, 95% CI 1.03–1.30). Moderate-quality evidence suggested an association with the presence of preoperative pain (OR 1.29, 95% CI 1.01–1.64). Given the 30% risk of pain in the absence of risk factors, the absolute risk increase corresponding to these ORs ranged from 3% (acute postoperative pain) to 21% (axillary lymph node dissection). High-quality evidence showed no association with body mass index, type of breast surgery, chemotherapy or endocrine therapy. Interpretation: Development of persistent pain after breast cancer surgery was associated with younger age, radiotherapy, axillary lymph node dissection, greater acute postoperative pain and preoperative pain. Axillary lymph node dissection provides the only high-yield target for a modifiable risk factor to prevent the development of persistent pain after breast cancer surgery.

Hemicraniectomy versus medical treatment with large MCA infarct: a review and meta-analysis

Objective Large middle cerebral artery stroke (space-occupying middle-cerebral-artery (MCA) infarction (SO-MCAi)) results in a very high incidence of death and severe disability. Decompressive hemicraniectomy (DHC) for SO-MCAi results in large reductions in mortality; the level of function in the survivors, and implications, remain controversial. To address the controversy, we pooled available randomised controlled trials (RCTs) that examined the impact of DHC on survival and functional ability in patients with large SO-MCAi and cerebral oedema. Methods We searched MEDLINE, EMBASE and Cochrane library databases for randomised controlled trials (RCTs) enrolling patients suffering SO-MCAi comparing conservative management to DHC administered within 96 hours after stroke symptom onset. Outcomes were death and disability measured by the modified Rankin Scale (mRS). We used a random effects meta-analytical approach with subgroup analyses (time to treatment and age). We applied GRADE methods to rate quality/confidence/certainty of evidence. Results 7 RCTs were eligible (n=338 patients). We found DHC reduced death (69–30% in medical vs surgical groups, 39% fewer), and increased the number of patients with mRS of 2–3 (slight to moderate disability: 14–27%, increase of 13%), those with mRS 4 (severe disability: 10–32%, increase of 22%) and those with mRS 5 (very severe disability 7–11%: increase of 4%) (all differences p<0.0001). We judged quality/confidence/certainty of evidence high for death, low for functional outcome mRS 0–3, and moderate for mRS 0–4 (wide CIs and problems in concealment, blinding of outcome assessors and stopping early). Conclusions DHC in SO-MCAi results in large reductions in mortality. Most of those who would otherwise have died are left with severe or very severe disability: for example, inability to walk and a requirement for help with bodily needs, though uncertainty about the proportion with very severe, severe and moderate disability remains (low to moderate quality/confidence/certainty evidence).

Effects of Antibiotic Prophylaxis in Patients with Open Fracture of the Extremities: A Systematic Review of Randomized Controlled Trials

Background:The purpose of the present study was to perform a systematic review and meta-analysis of the use of alternative antibiotic regimens—including (A) antibiotic prophylaxis versus no prophylaxis, (B) longer versus shorter duration of antibiotic prophylaxis, and (C) alternative drugs—for patients with open fracture of the extremities. Methods:Data sources included CINAHL, EMBASE, MEDLINE, the Cochrane Central Registry of Controlled Trials (CENTRAL), and the Cochrane database of systematic reviews from 1965 to December 2013. All randomized controlled trials comparing the effectiveness of antibiotic prophylaxis in patients with open fracture of the extremities were eligible. Results:We identified 329 potentially eligible articles, of which seventeen proved to be eligible. In four randomized controlled trials involving 472 patients, we found a significantly lower infection rate in patients receiving antibiotic prophylaxis compared with those not receiving antibiotic prophylaxis (risk ratio = 0.37 [95% confidence interval, 0.21 to 0.66]; absolute risk reduction = 9.6% [95% confidence interval, 5.2% to 12.1%]). In three studies involving 1104 patients, we found no difference in the infection rate when a longer duration of antibiotics (three to five days) was compared with a shorter duration (one day) (risk ratio = 0.97; 95% confidence interval, 0.69 to 1.37). Confidence in the estimates for both questions was low to moderate. Individual comparisons of alternative drugs yielded estimates warranting only low to very low confidence. Conclusions:Results of randomized controlled trials performed to date provide evidence that antibiotic prophylaxis reduces subsequent infection and that courses as short as one day are as effective as courses of three to five days, although the evidence warrants only low to moderate confidence. Given current practice, a large, multicenter, low risk of bias, randomized controlled trial enrolling representative populations and addressing the duration of antibiotics may be the next optimum step in investigation. Level of Evidence:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Predictors of Unemployment After Breast Cancer Surgery: A Systematic Review and Meta-Analysis of Observational Studies

Purpose Breast cancer surgery is associated with unemployment. Identifying high-risk patients could help inform strategies to promote return to work. We systematically reviewed observational studies to explore factors associated with unemployment after breast cancer surgery. Methods We searched MEDLINE, EMBASE, CINAHL, and PsycINFO to identify studies that explored risk factors for unemployment after breast cancer surgery. When possible, we pooled estimates of association for all independent variables reported by more than one study. Results Twenty-six studies (46,927 patients) reported the association of 127 variables with unemployment after breast cancer surgery. Access to universal health care was associated with higher rates of unemployment (26.6% v 15.4%; test of interaction P = .05). High-quality evidence showed that unemployment after breast cancer surgery was associated with high psychological job demands (odds ratio [OR], 4.26; 95% CI, 2.27 to 7.97), childlessness (OR, 1.30; 95% CI, 1.11 to 1.53), lower education level (OR, 1.15; 95% CI, 1.05 to 1.25), lower income level (OR, 1.46; 95% CI, 1.24 to 1.73), cancer stage II, III or IV (OR, 1.43; 95% CI, 1.13 to 1.82), and mastectomy versus breast-conserving surgery (OR, 1.18; 95% CI, 1.07 to 1.30). Moderate-quality evidence suggested an association with high physical job demands (OR, 2.11; 95%CI, 1.52 to 2.93), African-American ethnicity (OR, 1.89; 95% CI, 1.21 to 2.96), and receipt of chemotherapy (OR, 1.95; 95% CI, 1.36 to 2.79). High-quality evidence demonstrated no significant association with part-time hours, blue-collar work, tumor size, positive lymph nodes, or receipt of radiotherapy or endocrine therapy; moderate-quality evidence suggested no association with age, marital status, or axillary lymph node dissection. Conclusion Addressing high physical and psychological job demands may be important in reducing unemployment after breast cancer surgery.

GRADE guidelines: 20. Assessing the certainty of evidence in the importance of outcomes or values and preferences—inconsistency, imprecision, and other domains

OBJECTIVE To provide Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidance for assessing inconsistency, imprecision, and other domains for the certainty of evidence about the relative importance of outcomes. STUDY DESIGN AND SETTING We applied the GRADE domains to rate the certainty of evidence in the importance of outcomes to several systematic reviews, iteratively reviewed draft guidance, and consulted GRADE members and other stakeholders for feedback. RESULTS We describe the rationale for considering the remaining GRADE domains when rating the certainty in a body of evidence for the relative importance of outcomes. As meta-analyses are not common in this context, inconsistency and imprecision assessments are challenging. Furthermore, confusion exists about inconsistency, imprecision, and true variability in the relative importance of outcomes. To clarify this issue, we suggest that the true variability is neither equivalent to inconsistency nor imprecision. Specifically, inconsistency arises from population, intervention, comparison and outcome and methodological elements that should be explored and, if possible, explained. The width of the confidence interval and sample size inform judgments about imprecision. We also provide suggestions on how to detect publication bias and discuss the domains to rate up the certainty. CONCLUSION We provide guidance and examples for rating inconsistency, imprecision, and other domains for a body of evidence describing the relative importance of outcomes.

Evaluating Completeness of Reporting in Behavioral Interventions Pilot Trials: A Systematic Survey

Purpose: This systematic survey evaluates the completeness of reporting in pilot and feasibility randomized controlled trials investigating behavioral interventions based on the Consolidated Standards of Reporting Trials (CONSORT) extension for pilot trials. Methods: The authors searched Medline/Pubmed and randomly selected 100 articles from 2012 through 2016 to determine the proportion of reported CONSORT extension items. They examined study factors related to reporting, including year and country of publication, psychotherapy intervention, multiple centers, industry funding, and journal endorsement of CONSORT. Results: The authors found that the mean reporting score on the CONSORT extension was 51.6% (SD = 15.1). Studies of psychotherapy interventions had significantly higher reporting scores than other interventions (incidence rate ratio = 1.10, 95% confidence interval: 1.01–1.20). Conclusions: Our findings indicate that current reporting quality is suboptimal. Many included trials failed to provide rationale for piloting, assess feasibility objectives, or indicate clear progression to a future large trial. Reporting quality should be reevaluated following uptake of the 2016 CONSORT extension for pilot trials.

A Systematic Survey of Control Groups in Behavioral and Social Science Trials

Behavioral and social sciences randomized controlled trials (BSSTs) have a significant role in life sciences. Choosing an appropriate control or comparator group for BSSTs is critical, to provide true intervention effects. The objective of this study was to determine the types of control groups used in BSSTs, and the rationale provided to justify these choices. We conducted a systematic survey of BSST protocols published between January 2012 and October 2016 in the Cochrane Library and Medline databases. We randomly selected 200 protocols. The study selection and data extraction were performed independently in duplicate. The most frequent control groups were active concurrent (97/200, 48.5%), and no treatment concurrent controls (88/200, 44.0%). The majority of studies (71.5%) did not provide justification for comparators choice. We concluded that BSSTs trials compare interventions to active and no treatment controls however the majority of trials lacked rationale for the selection of the study comparator.