OBJECTIVE: High quality data entry in clinical trial databases is crucial to the usefulness, validity, and replicability of research findings, as it influences evidence-based medical practice and future research. Our aim is to assess the quality of self-reported data in trial registries and present practical and systematic methods for identifying and evaluating data quality.
METHODS: We searched ClinicalTrials.Gov for interventional total knee arthroplasty(TKA) trials between 2000-2015. We extracted required and optional trial information elements and used the CTG\'s variables\' definitions. We performed a literature review on data quality reporting on frameworks, checklists, and overviews of irregularities in healthcare databases. We identified and assessed data quality attributes: consistency, accuracy, completeness, and timeliness.
RESULTS: We included 816 interventional TKA trials. Data irregularities varied widely: 0% to 100%. Inconsistency ranged from 0% to 36%, most often non-randomized labeled allocation were combined with a \"single group\" assignment trial design. Inaccuracy ranged from 0% to 100%. Incompleteness ranged from 0% to 61%: 61% finished TKA trials did not report their outcome. As regard to irregularities in timeliness: 49% of the trials were registered more than 3 months after the start date.
CONCLUSIONS: We found significant variations in the data quality of registered clinical TKA trials. Trial sponsors should be committed to ensuring that the information they provide is reliable, consistent, up-to-date, transparent and accurate. CTG\'s users need to be critical when drawing conclusions based on the registered data. We believe this awareness will increase well-informed decisions about published articles and treatment protocols, including replicating and improving trial designs.

Congenital primary hypothyroidism (CH) and congenital adrenal hyperplasia (CAH) are targeted by the German and Austrian newborn screening. For both diseases, there are registries for quality improvement, based on standardized observational data from long-term patient follow-up, under the auspices of the DGKED study group. By September 2021, the CH registry HypoDOK includes datasets from 23,348 visits of 1,840 patients, and the CAH registry contains datasets from 36,237 visits of 1,976 patients. Here, we report on the recruitment process, patient characteristics, and research contributions from the registries, and underline that the registries are an important tool to improve patient care and outcomes. Registries for rare conditions should thus be considered as an important public health measure and they should be adequately institutionalized and funded.

A colonoscopy is a procedure commonly used for the diagnosis of colorectal diseases but may be associated with high levels of anxiety and discomfort, which can lead to complications during sedation and decreased patient comfort and cooperation. This study was conducted at a tertiary care hospital in Karachi to assess the effectiveness of music therapy on pre-procedural anxiety, sedation requirements, pain, and procedure duration among patients undergoing colonoscopies. This comparative study included 110 outpatients. The intervention arm received non-lyrical soft music through earphones before and during the colonoscopy procedure, while the control group did not receive any music. In the intervention arm, significant reductions were seen in pre-procedural anxiety scores (p < 0.001), physiological measures (p < 0.001), sedation doses (p < 0.001), and procedure durations (p < 0.05). Control arm showed an increase in heart rate and systolic blood pressure (p < 0.001). Pain scores were similar for both groups. Music therapy is an effective tool to reduce patient anxiety pre- procedure. It is a simple, safe, and noninvasive relaxing intervention that could be used as an adjunct to sedative medications before and during the colonoscopy procedure.

Background and study aims The number of procedures needed to acquire a sufficient level of skills to perform an unassisted evaluation of small bowel capsule endoscopy (SBCE) is unknown. We aimed to establish learning curves, diagnostic accuracy, and the number of procedures needed for reviewing small bowel capsule endoscopies unassisted. Methods An expert panel developed a 1-day course including lessons (examination, anatomy, and pathology) and hands-on training. After completing the course, participants received 50 cases in a randomized sequence. An interactive questionnaire about landmarks, findings, and diagnosis followed each case. After submitting the questionnaire, participants received feedback. Data are presented using CUSUM (cumulative sum control chart) learning curves and sensitivity/specificity analyses compared with expert opinions. Results We included 22 gastroenterologists from 11 different Danish hospitals. A total of 535 cases were reviewed (mean: 28; range: 11-50). CUSUM plots demonstrated learning progression for diagnosis and findings during the course, but none of the participants reached a learning plateau with sufficient competencies. The sensitivity for all findings was 65% (95% confidence interval [CI] 0.51-0.82) for the first 20 procedures and 67% (95% CI 0.58-0.73) from case 21 until completion or dropout. The specificity was 63% (95% CI 0.52-0.74) for the first 20 procedures and 57% (95% CI 0.37-0.77) for the rest. Conclusions Our data indicate that learning SBCE may be more difficult than previously recognized due to low discriminative abilities after 20 cases except for the identification of CD. This indicates that 20 SBCE cases may not be sufficient to achieve competency for reviewing SBCE without supervision.

Background and study aims Sedation of high-risk patients is a relevant issue in interventional endoscopy. This is especially because standard oximetric monitors display only hypoxia and not the preceding hypercapnia. Therefore, the question arises whether use of a nasal positive airway pressure (nPAP) system can decrease the rate of sedation-associated events. Patients and methods A randomized, prospective trial was conducted at University Hospital Ulm, including 98 consecutive patients, identified as high-risk (American Society of Anesthesiologists physical status ≥3) and scheduled for prolonged (>15 minutes) endoscopic procedures. Patients underwent 1:1 randomization to two groups: interventional (nPAP-Mask) and control (conventional oxygen supplementation). Levels of CO 2 were measured noninvasively by transcutaneous capnometry device. The primary outcome was incidence of hypoxia (SpO 2 <90% over 10 seconds) and incidence of severe hypoxia was incidence of SpO 2 <80% over 10 seconds. One of our secondary objectives was to determine if the nPAP-Mask could result in significant CO 2 retention among high-risk patients. Results Data analysis showed lower incidence of hypoxia in the interventional group (10/47 vs. 31/251) P <0.05. Episodes of severe hypoxia (SpO 2 <80% over 10 seconds) were more frequent in the control group (8/51) compared with the intervention group (2/47) P <0.05. There was no significant difference in ΔCO 2 levels in the interventional vs. control group (-6.01±7.66 vs. -7.35±8.59 mm Hg). Conclusions In high-risk patients use of a nasal positive airway pressure system could significantly lower risk of hypoxia, especially in prolonged procedures. The nPAP-Mask does not induce CO 2 retention when compared with conventional oxygen supplementation.

BACKGROUND: This paper aims to instigate discussion and publication of methodologies applied to enhance quality management through comprehensive scientific reports. It provides a detailed description of the design, implementation, and results of the quality control program employed in the SMESH study.
METHODS: Cross-sectional, multicenter, national study designed to assess the prevalence of human papillomavirus in sex workers and in men who have sex with men (MSM). Respondent-driven sampling recruitment was used. An online system was developed for the study and checkpoints were defined for data entry. The system checked the quality of biological samples and performed a retest with part of the sample.
RESULTS: A total of 1.598 participants (442 sex workers and 1.156 MSM) were included. Fifty-four health professionals were trained for face-to-face data collection. The retest showed Kappa values ranging between 0.3030 and 0.7663.
CONCLUSIONS: The retest data were mostly classified as indicating a strong association. The data generated by the checkpoints showed the successful implementation of the quality control program.

OBJECTIVE: Questionnaires designed to test knowledge and self-perception can be valuable tools for diagnosing a dentist\'s understanding of the management and administration of a practice. The objective of this study was to create and authenticate a questionnaire for assessing dentists\' self-perception on oral healthcare management developed from discussions with experts in this field.
METHODS: In order to create and verify a questionnaire survey, a cross-sectional, descriptive, and analytical study was carried out. Participants\' personal information and 31 statements across four categories made up the final questionnaire form. The answers to the questionnaire were in the form of a Likert scale. After refining the initial version, a total of 36 interviews were conducted at dental offices to verify the validity. For the Exploratory Factor Analysis (EFA), we used the Kaiser-Meyer-Olkin (KMO) index, the Bartlett sphericity test, and also Cronbach alpha coefficient for the validity of the questionnaire.
RESULTS: The accuracy of the instrument was measured by intrarater and interrater reliability. For the EFA, all the communalities exceeded the threshold of 0.05. With a Cronbach\'s alpha coefficient of 0.898, the questionnaire has sufficient internal consistency.
CONCLUSIONS: The questionnaire demonstrates robust reliability and validity, thereby affirming its suitability for its intended purpose.

Background and study aims The Plan-Do-Study Act (PDSA) ramp is a framework that uses initial small changes to build consensus and momentum for subsequent, iterative process improvement. Our aim was to study its impact on endoscopy unit efficiency and throughput. Methods Following a granular time-and-motion analysis to evaluate baseline performance (phase 1) we instituted successive interventions and measured their impact on core efficiency metrics including procedure volume and turnover time (phases 2-3). Results We identified that inefficiency in turnover of anesthesia-supported endoscopy was the most crucial issue. Implementation of a pre-procedure anesthesia visit in phase 2 reduced turnover time by 15.5 minutes (95% confidence interval 3.9-27.1 minutes). Subsequent changes (phase 3) including front-loaded procedure scheduling and parallel in-room preparation resulted in an 18% increase in procedure volume. Conclusions The PDSA ramp model is an effective means of assessing operational processes, developing novel interventions, and building consensus to improve the real-world productivity in a resource-conscious manner.

Background and study aims Musculoskeletal disorders (MSDs) and injuries (MSIs) are frequent in gastrointestinal endoscopy. The aim of this study was to assess potential ergonomic advantages of a lighter single-use duodenoscope compared with a standard reusable one for endoscopists performing endoscopic retrograde cholangiopancreatography (ERCP). Methods Three experienced endoscopists performed an ergonomic, preclinical, comparative protocol-guided simulation study of a single-use and a standard reusable duodenoscope using an anatomic bench model. Surface EMG signals from left forearm and arm muscles were recorded. A commercial inertial sensor-based motion capture system was applied to record body posture as well. Results A significant lowering of root mean square amplitude and amplitude distribution of biceps brachii signal (ranging from 13% to 42%) was recorded in all the participants when using a single-use duodenoscope compared with a reusable one. An overall reduction of muscle activation amplitude and duration was also associated with the single-use duodenoscope for forearm muscles, with different behaviors among subjects. Participants spent most of the time in wrist extension (> 80%) and ulnar deviation (> 65%). A consistent pattern of functional range of motion employed for completing all procedures was observed. Conclusions Our study showed that a lighter scope has a promising effect in reducing upper arm muscle activity during ERCP with potential benefit on musculoskeletal health in the ERCP setting.

BACKGROUND: As the most rapidly increasing neurodegenerative disease worldwide, Parkinson\'s disease is highly relevant to society. Successful treatment requires active patient participation. Patient education has been successfully implemented for many chronic diseases, such as diabetes and could also provide people with Parkinson\'s disease with skills to manage the disease better and to participate in shared decision making.
METHODS: To prepare the implementation of a concept for patient education for people with Parkinson\'s disease, a structured consensus study was conducted and a pilot project formatively evaluated. The structured consensus study included experts from all over Germany. It consisted of two online surveys and an online consensus conference. The formative evaluation was conducted as three focus groups. Transcripts were evaluated using content-structuring qualitative content analysis.
RESULTS: From the consensus procedure 59 consented statements emerged, mainly regarding the contents of a patient school and a group size of 6-8 persons. Only two statements could not be consented. The formative evaluation detected a tendency towards a positive attitude for a digital training format and a very positive evaluation of the contents.
CONCLUSIONS: Overall, important recommendations for a patient school can be drawn from this study. The following subjects require further investigation: format, inclusion criteria, group composition and inclusion of caregivers.
UNASSIGNED: HINTERGRUND: Die Parkinson-Krankheit ist als weltweit am schnellsten zunehmende neurodegenerative Erkrankung gesellschaftlich hoch relevant. Für eine erfolgreiche Behandlung ist die aktive Beteiligung der Patient*innen erforderlich. Patientenschulen werden bei vielen chronischen Erkrankungen wie Diabetes erfolgreich eingesetzt und könnten auch Menschen mit der Parkinson-Krankheit Fähigkeiten vermitteln, besser mit der Krankheit umzugehen und an Therapieentscheidungen teilzunehmen.
METHODS: Um die Implementierung eines Konzepts für eine Patientenschule für Menschen mit der Parkinson-Krankheit vorzubereiten, wurde ein strukturiertes Konsensusverfahren durchgeführt und ein Pilotprojekt formativ evaluiert. Das strukturierte Konsensusverfahren mit deutschlandweit rekrutierten Expert*innen gliederte sich in eine 1. und 2. Onlinebefragung sowie eine abschließende Konsensuskonferenz. Die formative Evaluation erfolgte durch drei Fokusgruppen. Die Transkripte dieser Gruppeninterviews wurden computergestützt mittels inhaltlich-strukturierender qualitativer Inhaltsanalyse ausgewertet.
UNASSIGNED: In dem Konsensusverfahren konnten 59 Aussagen konsentiert werden, insbesondere zu den Inhalten einer Patientenschule und zu einer Gruppengröße von 6 bis 8 Personen. Lediglich zwei Aussagen wurden nicht konsentiert. Aus der formativen Evaluation waren eine tendenziell positive Haltung gegenüber einem digitalen Schulungsformat und eine sehr positive Bewertung der Inhalte ableitbar.
CONCLUSIONS: Insgesamt konnten wichtige Empfehlungen für eine Patientenschule formuliert werden. Zu den Themen Format, Einschlusskriterien, Gruppenzusammensetzung und Einbeziehung von Angehörigen ist dagegen eine weitere Betrachtung erforderlich.