An Evaluation of the Content Quality, Readability, and Reliability of Publicly Available Web-Based Information on Pneumothorax Surgery in Ireland.

Introduction The internet is increasingly the first port of call for patients introduced to new treatments. Unfortunately, many websites are of poor quality, thereby limiting patients' ability to make informed health decisions. Within thoracic surgery, the treatment options for pneumothoraces may be less intuitive for patients to understand compared to procedures such as lobectomies and wedge resections. Therefore, patients must receive high-quality information to make informed treatment decisions. No study to date has evaluated online information regarding pneumothorax surgery. Knowledge regarding the same may allow physicians to recommend appropriate websites to patients and supplement remaining knowledge gaps. Objective This study aims to evaluate the content, readability, and reliability of online information regarding pneumothorax surgery. Methods A total of 11 search terms including "pneumothorax surgery," "pleurectomy," and "pleurodesis" were each entered into Google, Bing, and Yahoo. The top 20 websites found through each search were screened, yielding 660 websites. Only free websites designed for patient consumption that provided information on pneumothorax surgery were included. This criterion excluded 581 websites, leaving 79 websites to be evaluated. To evaluate website reliability, the Journal of American Medical Association (JAMA) and DISCERN benchmark criteria were applied. To evaluate the readability, 10 standardized tools were utilized including the Flesch-Kincaid Reading Ease Score. To evaluate website content, a novel, self-designed 10-part questionnaire was utilized to assess whether information deemed essential by the authors was included. It evaluated whether websites comprehensively described the surgery process for patients, including pre- and post-operative care. Website authorship and year of publication were also noted. Results The mean JAMA score was 1.69 ± 1.29 out of 4, with only nine websites achieving all four reliability criteria. The median readability score was 13.42 (IQR: 11.48-16.23), which corresponded to a 13th-14th school grade standard. Only four websites were written at a sixth-grade reading level. In the novel content questionnaire, 31.6% of websites (n = 25) did not mention any side effects of pneumothorax surgery. Similarly, 39.2% (n = 31) did not mention alternative treatment options. There was no correlation between the date of website update and JAMA (r = 0.158, p = 0.123), DISCERN (r = 0.098, p = 0.341), or readability (r = 0.053, p = 0.606) scores. Conclusion Most websites were written above the sixth-grade reading level, as recommended by the US Department of Health and Human Services. Furthermore, the exclusion of essential information regarding pneumothorax surgery from websites highlights the current gaps in online information. These findings emphasize the need to create and disseminate comprehensive, reliable websites on pneumothorax surgery that enable patients to make informed health decisions.

The Attitudes of Patients Toward Orthopaedic Post-surgical Scars.

Background Post-surgical scars (PSS) are an expected consequence of surgery. Several factors have previously been associated with PSS satisfaction including patient age and time elapsed post-operative. Little data are available regarding patient attitudes toward orthopaedic PSS. Knowledge of patient attitudes and the various associated factors may allow physicians to administer peri-operative care to mitigate the potential negative effects of PSS. Our study aims to investigate the attitudes of patients toward their PSS using quantitative scar assessment scales and to identify factors associated with PSS satisfaction. Methods We conducted a retrospective study with a follow-up. We included all patients with orthopaedic PSS on their upper or lower limbs between two and 18 weeks postoperative attending Cork University Hospital, Ireland, between February and August 2022. Patients completed an initial baseline questionnaire and then a follow-up questionnaire six months post-operative. The Patient and Observer Scar Assessment Scale (POSAS) evaluated PSS satisfaction. The European Quality of Life 5 Domain (EQ-5D), alongside several Likert scales, evaluated the patient's quality of life (QoL). Results In total, 91 patients were included. The mean POSAS score was 28.41 (95% CI, 25.85-30.97). Younger patient age (p=0.045) and decreased time passed post-operatively (p=0.002) were associated with poorer PSS satisfaction. Patients reporting their PSS appearing worse than expected were more likely to agree that their QoL had been adversely affected by it (p=0.001). Conclusion Most patients were satisfied with their orthopaedic PSS. This study identified several factors associated with poor PSS satisfaction. Our finding, which associated patient scar expectations and QoL, is novel and has not been previously examined. Accordingly, peri-operative interventions, including scar expectation management, may be implemented to mitigate scar-related QoL impact.

Patient-centered clinical trials.

We apply Bayesian decision analysis (BDA) to incorporate patient preferences in the regulatory approval process for new therapies. By assigning weights to type I and type II errors based on patient preferences, the significance level (α) and power (1-ß) of a randomized clinical trial (RCT) for a new therapy can be optimized to maximize the value to current and future patients and, consequently, to public health. We find that for weight-loss devices, potentially effective low-risk treatments have optimal αs larger than the traditional one-sided significance level of 5%, whereas potentially less effective and riskier treatments have optimal αs below 5%. Moreover, the optimal RCT design, including trial size, varies with the risk aversion and time-to-access preferences and the medical need of the target population.

Incorporating patient-preference evidence into regulatory decision making.

BACKGROUND: Patients have a unique role in deciding what treatments should be available for them and regulatory agencies should take their preferences into account when making treatment approval decisions. This is the first study designed to obtain quantitative patient-preference evidence to inform regulatory approval decisions by the Food and Drug Administration Center for Devices and Radiological Health. METHODS: Five-hundred and forty United States adults with body mass index (BMI) ≥ 30 kg/m(2) evaluated tradeoffs among effectiveness, safety, and other attributes of weight-loss devices in a scientific survey. Discrete-choice experiments were used to quantify the importance of safety, effectiveness, and other attributes of weight-loss devices to obese respondents. A tool based on these measures is being used to inform benefit-risk assessments for premarket approval of medical devices. RESULTS: Respondent choices yielded preference scores indicating their relative value for attributes of weight-loss devices in this study. We developed a tool to estimate the minimum weight loss acceptable by a patient to receive a device with a given risk profile and the maximum mortality risk tolerable in exchange for a given weight loss. For example, to accept a device with 0.01 % mortality risk, a risk tolerant patient will require about 10 % total body weight loss lasting 5 years. CONCLUSIONS: Patient preference evidence was used make regulatory decision making more patient-centered. In addition, we captured the heterogeneity of patient preferences allowing market approval of effective devices for risk tolerant patients. CDRH is using the study tool to define minimum clinical effectiveness to evaluate new weight-loss devices. The methods presented can be applied to a wide variety of medical products. This study supports the ongoing development of a guidance document on incorporating patient preferences into medical-device premarket approval decisions.