A Targeted Review of Worldwide Indirect Treatment Comparison Guidelines and Best Practices.

OBJECTIVES: Controls and governance over the methodology and reporting of indirect treatment comparisons (ITCs) have been introduced to minimize bias and ensure scientific credibility and transparency in healthcare decision making. The objective of this study was to highlight ITC techniques that are key to conducting objective and analytically sound analyses and to ascertain circumstantial suitability of ITCs as a source of comparative evidence for healthcare interventions. METHODS: Ovid MEDLINE was searched from January 2010 through August 2023 to identify publicly available ITC-related documents (ie, guidelines and best practices) in the English language. This was supplemented with hand searches of websites of various international organizations, regulatory agencies, and reimbursement agencies of Europe, North America, and Asia-Pacific. The jurisdiction-specific ITC methodology and reporting recommendations were reviewed. RESULTS: Sixty-eight guidelines from 10 authorities worldwide were included for synthesis. Many of the included guidelines were updated within the last 5 years and commonly cited the absence of direct comparative studies as primary justification for using ITCs. Most jurisdictions favored population-adjusted or anchored ITC techniques opposed to naive comparisons. Recommendations on the reporting and presentation of these ITCs varied across authorities; however, there was some overlap among the key elements. CONCLUSIONS: Given the challenges of conducting head-to-head randomized controlled trials, comparative data from ITCs offer valuable insights into clinical-effectiveness. As such, multiple ITC guidelines have emerged worldwide. According to the most recent versions of the guidelines, the suitability and subsequent acceptability of the ITC technique used depends on the data sources, available evidence, and magnitude of benefit/uncertainty.

[Effect of Bushen Tiaojing Recipe and Xiaoyao Pill on adenohypophysis and ovary in androgen-induced sterile rats: a comparative study].

OBJECTIVE: To observe the effect of Bushen Tiaojing Recipe (BTR) and Xiaoyao Pill (XYP) on the morphology and sex hormones secretion of adenohypophysis and ovaries in androgen-induced sterile rats (ASR). METHODS: Fifty 9-day old SD female rats randomly recruited from total 60 rats were subcutaneously injected with testosterone propionate to establish the ASR model. And the rest 10 rats were recruited as the normal group. Thirty successfully modeled rats were recruited and randomly divided into the model group, the BTR group (administered with BTR suspension), and the XYP group (administered with XYP suspension), 10 in each group. Five weeks later, rats were decapitated in the proestrus. Serum levels of estradiol (E2), progesterone (P), testosterone (T), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were detected by radioimmunoassay. The morphologies of adenohypophysis and ovary were observed after HE staining. RESULTS: Compared with the normal group, serum E2 and T levels increased, while FSH and LH levels decreased in the model group (all P < 0.01). The morphology of adenohypophysis and ovary was abnormal in the model group. Compared with the model group, serum E2 and T levels decreased, while FSH and LH levels increased in the BTR group and the XYP group (P < 0.05, P < 0.01). Besides, E2 and T levels in the BTR group and FSH levels in the XYP group restored to normal (all P > 0.05). The damaged structure of adenohypophysis and ovary got restored to different degrees. CONCLUSION: BTR and XYP both could improve ovulation failure.

Potential model for differential diagnosis between Crohn's disease and primary intestinal lymphoma.

AIM: To evaluate the usefulness of different parameters to differentiate Crohn's disease (CD) from primary intestinal lymphoma (PIL). METHODS: The medical records of 85 patients with CD and 56 patients with PIL were reviewed retrospectively. Demographic, clinical, laboratory, endoscopic, and computed tomographic enterography (CTE) parameters were collected. The univariate value of each parameter was analyzed. A differentiation model was established by pooling all the valuable parameters. Diagnostic efficacy was analyzed, and a receiver operating characteristic (ROC) curve was plotted. RESULTS: The demographic and clinical parameters that showed significant values for differentiating CD from PIL included age of onset, symptom duration, presence of diarrhea, abdominal mass, and perianal lesions (P < 0.05). Elevated lactate dehydrogenase and serum ß2-microglobulin levels suggested a PIL diagnosis (P < 0.05). The endoscopic parameters that showed significant values for differentiating CD from PIL included multiple-site lesions, longitudinal ulcer, irregular ulcer, and intraluminal proliferative mass (P < 0.05). The CTE parameters that were useful in the identification of the two conditions included involvement of ≤ 3 segments, circular thickening of the bowel wall, wall thickness > 8 mm, aneurysmal dilation, stricture with proximal dilation, "comb sign", mass showing the "sandwich sign", and intussusceptions (P < 0.05). The sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the differentiation model were 91.8%, 96.4%, 93.6%, 97.5%, and 88.5%, respectively. The cutoff value was 0.5. The area under the ROC curve was 0.989. CONCLUSION: The differentiation model that integrated the various parameters together may yield a high diagnostic efficacy in the differential diagnosis between CD and PIL.

Cost-effectiveness analysis of infant universal routine pneumococcal vaccination in Malaysia and Hong Kong.

Pneumococcal disease causes large morbidity, mortality and health care utilization and medical and non-medical costs, which can all be reduced by effective infant universal routine immunization programs with pneumococcal conjugate vaccines (PCV). We evaluated the clinical and economic benefits of such programs with either 10- or 13-valent PCVs in Malaysia and Hong Kong by using an age-stratified Markov cohort model with many country-specific inputs. The incremental cost per quality-adjusted life year (QALY) was calculated to compare PCV10 or PCV13 against no vaccination and PCV13 against PCV10 over a 10-year birth cohort's vaccination. Both payer and societal perspectives were used. PCV13 had better public health and economic outcomes than a PCV10 program across all scenarios considered. For example, in the base case scenario in Malaysia, PCV13 would reduce more cases of IPD (+2,296), pneumonia (+705,281), and acute otitis media (+376,967) and save more lives (+6,122) than PCV10. Similarly, in Hong Kong, PCV13 would reduce more cases of IPD cases (+529), pneumonia (+172,185), and acute otitis media (+37,727) and save more lives (+2,688) than PCV10. During the same time horizon, PCV13 would gain over 74,000 and 21,600 additional QALYs than PCV10 in Malaysia and Hong Kong, respectively. PCV13 would be cost saving when compared against similar program with PCV10, under both payer and societal perspective in both countries. PCV13 remained a better choice over PCV10 in multiple sensitivity, scenario, and probabilistic analyses. PCV13s broader serotype coverage in its formulation and herd effect compared against PCV10 were important drivers of differences in outcomes.