Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study.

BACKGROUND: Pilot studies are essential in determining if a larger study is feasible. This is especially true when targeting populations that experience stigma and may be difficult to include in research, such as people with HIV. We sought to describe how pilot studies have been used to inform HIV clinical trials. METHODS: We conducted a methodological study of pilot studies of interventions in people living with HIV published until November 25, 2020, using Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL). We extracted data on their nomenclature, primary objective, use of progression criteria, sample size, use of qualitative methods, and other contextual information (region, income, level, type of intervention, study design). RESULTS: Our search retrieved 10,597 studies, of which 248 were eligible. The number of pilot studies increased steadily over time. We found that 179 studies (72.2%) used the terms "pilot" or "feasibility" in their title, 65.3% tested feasibility as a primary objective, only 2% used progression criteria, 23.9% provided a sample size estimation and only 30.2% used qualitative methods. CONCLUSIONS: Pilot studies are increasingly being used to inform HIV research. However, the titles and objectives are not always consistent with piloting. The design and reporting of pilot studies in HIV could be improved.

Arthroscopic versus Open Osteochondral Autograft Transplantation (Mosaicplasty) for Cartilage Damage of the Knee: A Systematic Review.

Osteochondral autograft transplantation (OAT) is a surgical option for repairing cartilage damage in knees, and can be performed using open or arthroscopic procedures. The aim of this review was to report clinical outcomes, postoperative complications, defect location, and defect size between open and arthroscopic OATs. Three electronic databases (EMBASE, PUBMED, and MEDLINE) were searched for relevant articles. In regard to eligibility criteria, knee articular damage cases solely treated with OAT were included and cases concomitant with ligament reconstruction, limb realignment, and meniscus repair were excluded. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and descriptive statistics are presented. A total of 24 studies were included with a total sample of 1,139 patients (532 in open OAT vs. 607 in arthroscopic OAT). Defect size in open OAT was three times larger than that of arthroscopic OAT (2.96 ± 0.76 vs. 0.97 ± 0.48 cm2). In terms of defect location, the medial femoral condyle (MFC) was the most common (75.4%), followed by the lateral femoral condyle (LFC; 12.1%), patella (6.7%), and trochlea (5.7%). All of these defect locations were treated with open OAT, whereas arthroscopic OAT treatments were restricted to the MFC and LFC. The clinical outcomes were overall favorable with the modified Hospital for Special Surgery knee scores being 89.6 ± 8.0 (36.1-month follow-up) versus 90.4 ± 6.0 (89.5-month follow-up) and the Lysholm scores being 81.6 ± 8.9 (44.2-month follow-up) and 83.3 ± 7.4 (12.0-month follow-up) between open and arthroscopic OATs, respectively. Fifty-three postoperative complications were observed (39/279 vs. 14/594) and the most common complication was hemarthrosis (13/39 in open, vs. 1/14 in arthroscopic OAT). The overall clinical outcomes were favorable in open and arthroscopic OATs, whereas open OAT allowed for treatment of lesions approximately three times greater in dimension than in arthroscopic OAT. Also, defect location was restricted to MFC and LFC in arthroscopic OAT. The most common complication was hemarthrosis.

The efficacy of teriparatide on lumbar spine bone mineral density, vertebral fracture incidence and pain in post-menopausal osteoporotic patients: A systematic review and meta-analysis.

OBJECTIVE: Teriparatide has been increasingly utilized in the management of osteoporosis. The efficacy of low and high dose teriparatide on lumbar spine bone mineral density, vertebral fracture incidence and pain is unknown. We sought to determine the efficacy of teriparatide on these patient-important outcomes using a systematic review and meta-analysis. METHODS: A systematic search of electronic databases (MEDLINE, EMBASE, CENTRAL, CINAHL) was performed to identify randomized controlled trials (RCTs) that evaluate teriparatide to any comparator for the treatment of osteoporosis in postmenopausal women. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria were used by two independent reviewers to assess the strength and quality of evidence. RESULTS: A total of 20 studies (n = 6024) were included in this review, with 2855 patients receiving teriparatide and 3169 patients receiving placebo or control treatment. A teriparatide dose of 20 µg/day increased lumbar spine bone mineral density (BMD) (standardized mean difference (SMD) 0.34 standard deviation (SD) units higher (95% CI 0.19-0.48 SDs higher) in comparison to placebo. Relative to anti-resorptive agents, 20 µg/day of teriparatide had a range from 0.14 SD units to 0.96 SD units higher (95% CI, 0.08 SDs lower to 0.36 SDs higher, CI, 0.33-1.59 SDs higher, respectively). 20 µg/day teriparatide had a significant effect on pain severity to placebo or control (SMD 0.80, 95% CI, 1.16-0.43 SDs lower) and also decreased the incidence of vertebral fractures compared to placebo (relative risk 0.31, 95% CI 0.21 to 0.46). Arthralgia and extremity pain incidence were also calculated; there were 15 and 8 fewer events per 1000 patients with the use of 20 µg/day of teriparatide compared to placebo or control, respectively. CONCLUSION: High quality evidence supports the utilization of teriparatide 20 µg/day dose to significantly improve lumbar spine BMD and decrease incidence of vertebral fractures and pain severity relative to all comparators. 40 µg/day dose of teriparatide demonstrated significantly better results with prolonged treatment. This data is valuable for clinicians involved in the care of this growing demographic of patients. Further investigation on the safety and efficacy of teriparatide in higher doses for the long-term treatment of osteoporosis in postmenopausal women should be conducted through high-quality clinical trials.

Efficacy of Electrical Stimulation for Spinal Fusion: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Spinal fusion is one of the most common procedures performed in spine surgery. As rates of spinal fusion continue to increase, rates of complications such as nonunions continue to increase as well. Current evidence supporting the use of electrical stimulation to promote fusion is inconclusive. This review aimed to determine if postoperative electrical stimulation is more efficacious than no stimulation or placebo in promoting radiographic fusion in patients undergoing spinal fusion. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, CINAHL and MEDLINE from date of inception to current. Ongoing clinical trials were also identified and reference lists of included studies were manually searched for relevant articles. Two reviewers independently screened studies, extracted data, and assessed risk of bias. Data were pooled using the Mantel-Haenszel method. Trialists were contacted for any missing or incomplete data. Of 1184 articles screened, 7 studies were eligible for final inclusion (n = 941). A total of 487 patients received postoperative electrical stimulation and 454 patients received control or sham stimulation. All evidence was of moderate quality. Electrical stimulation (pulsed electromagnetic fields, direct current, and capacitive coupling) increased the odds of a successful fusion by 2.5-fold relative to control (OR = 2.53, 95% CI 1.86 to 3.43, p < 0.00001). A test for subgroup interaction by stimulation type, smoking status, and number of levels fused was not significant (p = 0.93, p = 0.82 and p = 0.65, respectively). This systematic review and meta-analysis found moderate-quality evidence supporting the use of postoperative electrical stimulation as an adjunct to spinal fusion surgery. Patients treated with electrical stimulation have significantly greater rates of successful fusion. The level of evidence for this study is therapeutic level I.