In order to better incorporate patient input in clinical trials, the US Food and Drug Administration has included "patient-focused drug development" in the selection and development of clinical outcome assessments, and formulated a series of guidelines. Based on the third guiding principle, "Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments", this article summarizes the clinical outcome assessments from five aspects: concept, development process, scoring mechanism, interference factors and sensitivity, and introduces four different types of clinical outcome assessments, providing new ideas for "patient-focused drug development" efficacy evaluation in clinical trials.
Objective To analyze the changes of perioperative symptoms of lung cancer patients by using patient-reported outcomes at different time points. MethodsA total of 109 patients who underwent thoracoscopic lung cancer resection in the department of thoracic surgery of our hospital from March to April 2021 were selected, including 55 (50.46%) males and 54 (49.54%) females. The mean age was 55.19±12.12 years. The postoperative symptom scale for lung cancer patients was used to investigate the changes of symptoms before surgery, 1 day after surgery, the day of discharge, and 30 days after surgery. Results The mean hospital stay was 6.89±2.25 days. None of the patients reported any clinical symptoms related to lung cancer before surgery. The most prominent symptoms 1 day after surgery were pain (3.33±0.96 points), nausea (2.81±1.18 points), dizziness (2.00±0.85 points), fatigue (1.89±0.79 points) and shortness of breath (1.79±1.37 points). The patients with dizziness, nausea, fatigue and other symptoms gradually decreased, and the symptoms were relieved significantly (P<0.05). However, the symptoms of conscious pain, cough and shortness of breath lasted for a long time. At 30 days after surgery, 70.64%, 64.22% and 33.03% of patients felt pain, cough and shortness of breath, respectively, and the degree of cough was aggravated (P<0.001). Conclusion Pain, cough, dizziness, shortness of breath and fatigue are the core postoperative symptoms of lung cancer patients. Most postoperative adverse symptoms can be effectively controlled in a short period of time, but pain, cough and shortness of breath still present persistent characteristics, which deserve further study.
Objective Based on the PSQ-18 scale, to evaluate the effects of disease classification early warning system (DCEWS) on operation quality of health examination center (HEC). Methods By means of the comparable and retrospective cohort study methods, using “PSQ-18” of American Rand Corporation as a tool, taking the date when HEC implemented DCEWS as node, and adopting statistic software for random sampling, it was divided into two groups: the traditional group (before implementing DCEWS, n=475) and the early warning group (after implementing DCEWS, n=473). The PSQ-18 scale scores of both groups were analyzed so as to assess the effects of DCEWS on HEC. Results Such factors as sex, age, education level and family average monthly income had certain effects on the score of PSQ-18, but there was no significant difference between the two groups (Pgt;0.05); in the following 4 dimensions as the ways of interpersonal communication, degree of doctor-patient communication, convenience degree and the overall satisfaction of patients, the PSQ-18 scores of the traditional group and the early warning group were 4.0±0.92/4.2±0.97, 3.8±0.94/4.0±0.96, 4.4±0.60/4.6±0.6, 4.2±0.87/4.4±0.94, respectively, with significant differences (all Plt;0.05). Conclusion The implementation of “Disease classification early waning system” can significantly increase the “patient satisfaction” of health examinees, and can significantly improve the operation quality of health examination center.
ObjectivesTo systematically review the patients’ satisfaction of implant supported mandibular dentures and conventional dentures.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang and VIP databases were searched to collect randomized controlled trials (RCTs) on patients’ satisfaction of implant supported mandibular dentures (IODs) and conventional dentures (CDs) from inception to November 31st, 2016. Two reviewers independently screened literature, extracted data and evaluated the risk of bias of the included studies. Then, meta-analysis was conducted using RevMan 5.3 software.ResultsSeven randomized-controlled trials were identified. The results of meta-analysis showed that compared with CDs group, IODs group had a relatively higher level of patients’ satisfaction (SMD=1.11, 95%CI 0.79 to 1.43, P<0.001) and oral health quality of life (MD=–12.41, 95%CI –18.96 to –5.86,P<0.001).ConclusionsThe current evidence suggests that IODs may be a better choice for mandibular edentulous patients than CDs. Due to the limitations of the quality and quantity of the included studies, the above conclusions still require larger sample and high quality research to verify.
Objective To evaluate if performing thyroidectomy through small incision has any notable aesthetic impact on patients compared with larger incision. Methods Thirty consecutive patients underwent thyroidectomy were enrolled from March 2008 to June 2008 in this prospective randomized pilot study. The incision length was 6 cm in the small incision group and 9 cm in the larger incision group. After 3 years follow-up，the scar aesthetics were evaluated by patients and surgeons using the Patient and Observer Scar Assessment Scale （POSAS），Vancouver Scar Scale （VSS），respectively. Digital photographs about scars were taken and assessed by non-research related viewers. Results There were 13 cases who received scar aesthetic assessment in both groups. The demographic characteristics of both groups were comparative. The overall patients’ satisfactions for the small incision group and the larger incision group were （2.5±1.9） scores and （2.2±1.5）scores， respectively （P=0.55）. There were no significant differences in scar assessment scale score as for other scar assessment scales （including VSS score，PSAS score，and OSAS score） between the two groups. The evaluation of digital photographs about scars by non-research related viewers was no significant difference （P＞0.05）. Conclusion Larger cervical scar in thyroidectomy does not decrease patients’ satisfaction with their scar results.
Objective To evaluate the effectiveness of intravenous patient-controlled analgesia versus epidural patient-controlled analgesia for postoperative analgesia, sedation, and the incidence of side effects. Methods We searched the specialized trials registered in the Cochrane anesthesia group, The Cochrane Library (CCTR), MEDLINE (1966 to Sept. 2008), EMbase (1966 to Sept. 2008), PubMed (1966 to Sept. 2008), and handsearched some Chinese anesthesia Journals and Clinical anesthesia journals. Randomized controlled trials (RCTs) and quasi-RCTs of intravenous versus epidural analgesia for post-operation were included. The quality of the trials was critically assessed. RevMan 4.2.8 software was used for meta-analyses. Results Thirteen RCTs involving 580 patients of intravenous versus epidural analgesia for post-operation were included. The results of meta-analyses showed that there were no significant differences in postoperative analgesia and sedation at the hour-points of 2nd, 4th, 8th, 12th, and 24th hours after operation. There were no significant differences in plasma fentanyl concentration in the two groups on the same analgesia effects. There were also no significant differences in side effects. Conclusion Both intravenous patient-controlled analgesia and epidural patient-controlled analgesia have the same clinical effects. Compared with epidural patient-controlled analgesia, intravenous patient-controlled analgesia has fewer side effects and is more convenient. At the same time, it can reduce more costs of hospitalization. But because of the low quality and small sample size of the included studies, more well-designed, large scale, randomized controlled trials are needed.
The COSMIN-RoB checklist includes three sections with a total of 10 boxes, which is used to evaluate risk of bias of studies on content validity, internal structure, and other measurement properties. COSMIN classifies reliability, measurement error, criteria validity, hypothesis testing for construct validity, and responsiveness as other measurement properties, which primarily focus on the quality of the (sub)scale as a whole, rather than on the item level. Among the five measurement properties, reliability, measurement error and criteria validity are the most widely used in the studies. Therefore, this paper aims to interpret COSMIN-RoB checklist with examples to guide researchers to evaluate the risk of bias of the studies on reliability, measurement error and criteria validity of PROMs.
Mitral valve regurgitation is one of the most common heart valve diseases, of which secondary mitral valve regurgitation (sMR) has large proportion and poor prognosis. For patients who still have symptoms after the guideline-directed management and therapy, the effects of surgery are controversial, and transcatheter therapy provides a new option. Transcatheter edge-to-edge repair has become one of the recommended therapies by the guidelines, meanwhile transcatheter mitral valve annuloplasty and transcatheter mitral valve replacement are developing. However, the etiological mechanism of sMR is complex and diverse. There is an interaction between cardiac function and structure and sMR in dynamic change. It brings challenges to the selection of indicators and evaluation timing. The complex anatomical structure also makes it more difficult to design instruments and select surgical methods. This paper reviews the challenges and progress of transcatheter therapy for sMR.
Objective Interpretation of the growing body of global literature on health care risk is compromised by a lack of common understanding and language. This series of articles aims to comprehensively compare laws and regulations, institutional management, and administration of incidence reporting systems on medical risk management in the United Kingdom, the United States, Canada, Australia, and Taiwan, so as to provide evidence and recommendations for health care risk management policy in China. Methods?We searched the official websites of the healthcare risk management agencies of the four countries and one district for laws, regulatory documents, research reports, reviews and evaluation forms concerned with healthcare risk management and assessment. Descriptive comparative analysis was performed on relevant documents. Results?A total of 146 documents were included in this study, including 2 laws (1.4%), 17 policy documents (11.6%), 41 guidance documents (28.1%), 37 reviews (25.3%), and 49 documents giving general information (33.6%). The United States government implemented one law and one rule of patient safety management, while the United Kingdom and Australia each issued professional guidances on patient safety improvement. The four countries implemented patient safety management policy on four different levels: national, state/province/district, hospital, and non-governmental organization. Conclusion?The four countries and one district adopted four levels of patient safety management, and the administration modes can be divided into an “NGO-led mode” represented by the United States and Canada and a “government-led mode” represented by the United Kingdom, Australia, and Taiwan.