High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
ObjectiveTo summarize the new ideas and new instruments in thyroid surgery. MethodsRelated literatures were reviewed and analyzed. ResultsTotal thyroidectomy had become the preferred option for differentiated thyroid cancer and multiple nodule goiter. The key change of surgery was from recurrent laryngeal nerve-protection to parathyroid-protection. Harmonic scalpel, bipolar coagulation forceps and Ligasure were used to thyroid surgery, which could shorten operation time and reduce operative bleeding. ConclusionThe ideas and techniques of thyroid surgery have changed, total thyroidectomy and parathyroid protection are being paid more and more attentions, and new instruments are used more extensively in thyroid surgery.
An intervention with clinical application must be effective and safe, therefore, when evaluating interventions, the benefit-harm ratio should be considered, and only those interventions with more benefits than harms have application value. To evaluate the benefits and harms of an intervention evidence of both benefits and harms should be reported in clinical trials. To promote better reporting of harms in randomized controlled trials, the CONSORT group had added an entry on harms in the 2001 version of the CONSORT statement, and then in 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated, the reporting of harms is still inadequate. The CONSORT group has updated《Better reporting of harms in randomized trial: an extension of the CCONSORT statement.》, published《CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials》. This article presents and explains the Harms 2022, with the aim of helping researchers better understand and use the statement, with a view to improving the reporting quality of harms in clinical trials.
Objective To compare the advantages and disadvantages of using the harmonic scalpel and bipolar coagulation forceps versus harmonic scalpel and conventional clamp-and-tie technique in open thyroid surgery.Methods One hundred patients indicated for thyroid surgery were randomly divided into two groups：the bipolar coagulation forceps group underwent surgery with harmonic scalpel and bipolar coagulation forceps，and the conventional clamp-and-tie group with harmonic scalpel and conventional clamp-and-tie technique，respectively.All operations were performed by the same group of doctors.The total operation time，intraoperative bleeding，mass diameter，postoperative drainage，and surgical complications （postoperative bleeding， postoperative recurrent laryngeal nerve paralysis，seroma，and permanent postoperative hypoparathyroidism） were compared.Results There were 48 valid cases in the bipolar coagulation forceps group， and 49 cases in the conventional clamp-and-tie group. There were no significant differences between two groups patients of age，gender，disease composition，and mass diameter（P＞0.05）.With the same operative approach， the total operation time，intraoperative bleeding，and the incidence of transient postoperative hypoparathyroidism in the bipolar coagulation forceps group were significantly lower than those in the conventional clamp-and-tie group （P＜0.001）.The postoperative drainage in the bipolar coagulation forceps group was more than that in the conventional clamp-and-tie group （P＜0.05）.There was no single case of postoperative bleeding，postoperative recurrent laryngeal nerve paralysis，seroma，and permanent postoperative hypoparathyroidism in both groups.Conclusions The combination of harmonic scapel with bipolar coagulation forceps provides significant advantages over the combination of harmonic scapel with conventional clamp-and-tie technique in open thyroid surgery.
ObjectivesTo systematically review the safety of harmonic scalpel and conventional resection in superficial parotidectomy.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) or cohort studies of harmonic scalpel and conventional resection in superficial parotidectomy from the inception of the database to December, 2018. Two reviewers independently screened literatures, extracted data and assessed risk of bias of the included studies. Then meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 10 studies involving 671 post-cesarean section patients (361 patients in harmonic scalpel group and 310 patients in conventional resection group) were included. The results of meta-analysis showed that: compared with conventional resection, harmonic scalpel had shorter operative time (MD=?23.82, 95%CI ?31.20 to ?16.44, P<0.000 01), less postoperative drain output (MD=?26.25, 95%CI ?38.95 to ?13.55, P<0.000 1), less intraoperative blood loss (MD=?23.78, 95%CI ?28.64 to ?18.91, P<0.000 01), shorter duration of hospital stay (MD=?1.19, 95%CI ?2.14 to ?0.23, P=0.02), and lower temporary facial nerve palsy rate (OR=0.27, 95%CI 0.14 to 0.50, P<0.000 1). However, there was no significant difference in the incidence of parotid gland leakage between two groups (OR=0.42, 95%CI 0.16 to 1.06, P=0.07).ConclusionsThe current evidence demonstrates that, compared to conventional resection, harmonic scalpel resection is safer. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Objective To evaluate the clinical effects of harmonic scalpel application in thoracoscopic surgery for lung cancer, which may guide its reasonable application. Methods We retrospectively analyzed the clinical data of 145 lung cancer patients receiving thoracoscopic surgery from January to March 2017 in our hospital. There were 57 patients with thoracoscopic pulmonary wedge resection, and harmonic scalpel was used in 34 patients (8 males, 26 females at age of 59.68±10.91 years), and was not used in 23 patients (13 males and 10 females at age of 59.13±11.21 years). There were 88 patients receiving thoracoscopic pulmonary lobectomy, among whom harmonic scalpel was used in 80 patients (36 males and 44 females at age of 59.68±10.91 years), and was not used in 8 patients (5 males, 3 females at age of 61.63±5.60 years). We recorded the perioperative outcomes of all patients. Results In the 34 patients undergoing thoracoscopic pulmonary wedge resection by harmonic scalpe, the operation time was 90.09±43.52 min, the blood loss was 21.32±12.75 ml, the number of lymph nodes resected was 5.12±4.26, duration of drainage was 3.15±1.16 d, volume of drainage was 535.00±291.69 ml, the length of postoperative hospital stay was 4.56±1.40 d, and no postoperative complication was observed. In the 80 patients receiving thoracoscopic pulmonary lobectomy by harmonic scalpel, operation time was 131.88±41.82 min, blood loss was 42.79±31.62 ml, the number of lymph nodes resected was 13.54±8.75, duration of thoracic drainage was 4.47±2.30 d, drainage volume was 872.09±585.24 ml, the length of postoperative hospital stay was 5.81±2.26 d, and 20 patients had postoperative complications. No complication occurred in the 8 patients without harmonic scalpel. Conclusion Harmonic scalpel showed satisfactory effectiveness and safety in lung cancer thoracoscopic surgery.
ObjectiveTo explore the feasibility and safety of clinical application of bipolar coagulation forceps in open thyroid operations and summarize the operation skill. MethodsThe clinical data of 347 cases performed thyroid operations with bipolar coagulation forceps and Harmonic scalpel respectively from October 2010 to October 2014 in our hospital were analyzed retrospectively. ResultsNo statistical differences was found on the operative time, intraoperative bleeding, postoperative drainage, and postoperative hospitalization of the two groups (P > 0.05). The complications of transient palsy of recurrent laryngeal nerve and transient functional insufficiency of parathyroid were more in Harmonic scalpel group than in bipolar coagulation forceps group with statistical difference (P < 0.05). But there was no difference of the complications of airway obstruction, permanent injuries of recurrent laryngeal nerve, parathyroid and superior laryngeal nerve in the two groups (P > 0.05). ConclusionsThyroid operations with bipolar coagulation forceps are safe and feasible. Coagulation tightly along the thyroid capsule followed by incision with explicit subtle dissection is the key point of the decrease of complications.
NNT defines the number of patients who need to be treated in order to achieve one additional favorable outcome, and NNH is defined as the number of patients who must be treated with a therapy in order to have one additional patient suffer an adverse effect compared with the control treatment. This is the most important thing that should beconsidered before administering a treatment. NNT can also be used to assess the relative benefit or harm in the comparison of intervention versus positive control. If the effect is smaller in the intervention group than that in the control group, NNT should be used; if the effect is bigger in the intervention group than that in the control group, NNH should be used. When comparison is made between an intervention versus placebo, NNT and NNH are absolute outcomes; when an intervention is compared to a positive control, NNT and NNH are relative outcomes. RR or OR or RD may help to judge which comparator has bigger or smaller effect, and whether NNT or NNH should be used.
It is essential to improve the practice of community healthcare service for the resolution of the problem of inadequate and overly expensive medical services, to promote the harmonization of doctor-patient relationship. From the aspects of the introduction of community healthcare service and the necessity of its standard management, the civil legal relation of community healthcare and its major problems, as well as the rights and duties of community doctors, the authors discussed the importance and necessity of scientific management, right protection by law as well as sound and orderly development of community healthcare service.
Statistical graph is an indispensable part of scientific papers. It is helpful to promote the communication, dissemination, and application of academic achievements by presenting research results intuitively and accurately through standardized and beautiful visual graphs. The safety of a medical intervention is the basic premise of its clinical application, and randomized controlled trial (RCT) as an important design to determine the efficacy and safety of medical interventions, it is extremely important to accurately present the information on the safety outcomes of interventions found therein. However, the research found that the reports of RCTs didn’t adequately use visual graphs to present harms data. In order to promote clinical researchers to better use visual graphs to present harms data, international scholars recently published a consensus study in BMJ, which identified and recommended 10 statistical graphs for presenting harms data in RCTs. In order to facilitate domestic scholars to understand and apply the consensus, this article interprets the consensus and recommendations, and it is expected to provide help for improving the quality of harms visualization in domestic papers of RCTs.