Category: Statistics

Eur J Cancer Prev. 2023 Nov 30. doi: 10.1097/CEJ.0000000000000845. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the quality of apps for prostate cancer antigen (PSA) dosage, available for downloading on the iOS and Android platforms, discussing the potential role of mobile health applications (MHAs) in update the screening protocol.

METHODS: An observational cross-sectional descriptive study of all smartphone apps for PSA dosage was performed through the most used platforms (iOS and Android). On 10 February 2023, a total of 457 apps were found according to the search criteria. Mobile Application Rating Scale (MARS) was adopted to assess apps’ quality. Then, MARS items were analyzed through descriptive statistics and bivariate correlations between study variables with Pearson’s coefficient.

RESULTS: Of all samples, 24 MHAs were included in the final analysis: 12% (n = 3) from the iTunes App Store and 88% (n = 21) from the Google Play Store. According to the MARS quality assessment, the mean values 2.61, 2.94, 3.11, 2.97, 2.94, and 2.63 were measured for the engagement, functionality, aesthetics, information, overall mean score, and subjective quality, respectively.

CONCLUSION: The MHAs for PSA were under the acceptability threshold and future improvements are required. Moreover, MHAs appropriately developed could play an active role in PSA screening campaign and adherence of follow-up regimens. Finally, the virtual instrument could both reduce the social divide of access to care for patients in rural areas and improve PCA detection, speeding up the active treatment.

PMID:38051582 | DOI:10.1097/CEJ.0000000000000845

JMIR Form Res. 2023 Dec 5;7:e49786. doi: 10.2196/49786.

ABSTRACT

BACKGROUND: While the COVID-19 pandemic dramatically increased virtual care uptake across many health settings, it remains significantly underused in urgent care.

OBJECTIVE: This study evaluated the implementation of a pilot virtual emergency department (VED) at an Ontario hospital that connected patients to emergency physicians through a web-based portal. We sought to (1) assess the acceptability of the VED model, (2) evaluate whether the VED was implemented as intended, and (3) explore the impact on quality of care, access to care, and continuity of care.

METHODS: This evaluation used a multimethods approach informed by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. Data included semistructured interviews with patients and physicians as well as postvisit surveys from patients. Interviews were transcribed and analyzed using thematic analysis. Data from the surveys were described using summary statistics.

RESULTS: From December 2020 to December 2021, the VED had a mean of 153 (SD 25) visits per month. Among them, 67% (n=677) were female, and 75% (n=758) had a family physician. Patients reported that the VED provided high-quality, timely access to care and praised the convenience, shorter appointments, and benefit of the calm, safe space afforded through virtual appointments. In instances where patients were directed to come into the emergency department (ED), physicians were able to provide a “warm handoff” to improve efficiency. This helped manage patient expectations, and the direct advice of the ED physician reassured them that the visit was warranted. There was broad initial uptake of VED shifts among ED physicians with 60% (n=22) completing shifts in the first 2 months and 42% (n=15) completing 1 or more shifts per month over the course of the pilot. There were no difficulties finding sufficient ED physicians for shifts. Most physicians enjoyed working in the VED, saw value for patients, and were motivated by patient satisfaction. However, some physicians were hesitant as they felt their expertise and skills as ED physicians were underused. The VED was implemented using an iterative staged approach with increased service capabilities over time, including access to ultrasounds, virtual follow-ups after a recent ED visit, and access to blood work, urine tests, and x-rays (at the hospital or a local community laboratory). Physicians recognized the value in supporting patients by advising on the need for an in-person visit, booking a diagnostic test, or referring them to a specialist.

CONCLUSIONS: The VED had the support of physicians and facilitated care for low-acuity presentations with immediate benefits for patients. It has the potential to benefit the health care system by seeing patients through the web and guiding patients to in-person care only when necessary. Long-term sustainability requires a focus on understanding digital equity and enhanced access to rapid testing or investigations.

PMID:38051562 | DOI:10.2196/49786

J Med Internet Res. 2023 Dec 5;25:e48623. doi: 10.2196/48623.

ABSTRACT

BACKGROUND: Several studies have demonstrated the efficacy and user acceptance of telehealth in managing patients with chronic conditions, including continuous ambulatory peritoneal dialysis (CAPD). However, the rates of telehealth service use in various patient groups have been low and have declined over time, which may affect important health outcomes. Telehealth service use in patients undergoing CAPD has been recognized as a key challenge that needs to be examined further.

OBJECTIVE: This study aimed to explore the rates of telehealth service use over 4 months, identify factors influencing its use, and examine the relationship between telehealth service use and health outcomes in Thai people undergoing CAPD.

METHODS: This cross-sectional study, which was a part of a pragmatic randomized controlled trial study, was conducted at a dialysis center in Bangkok, Thailand. The study included patients who were undergoing CAPD. These patients were randomly enrolled in the intervention group to receive telehealth service and additional standard care for 4 months. Data were collected using self-reported questionnaires, including a demographic form, Functional, Communicative, and Critical Health Literacy Scale, Perceived Usefulness Questionnaire, Brief Illness Perception Questionnaire, Patient-Doctor Relationship Questionnaire, and Kidney Disease Quality of Life 36 Questionnaire. Additionally, Google Analytics was used to obtain data on the actual use of the telehealth service. These data were analyzed using descriptive statistics, repeated-measures ANOVA, and regression analyses.

RESULTS: A total of 159 patients were included in this study. The mean rate of telehealth service use throughout the period of 4 months was 62.06 (SD 49.71) times. The rate of telehealth service use was the highest in the first month (mean 23.48, SD 16.28 times) and the lowest in the third month (mean 11.09, SD 11.48 times). Independent variables explained 27.6% of the sample variances in telehealth service use. Older age (β=.221; P=.002), higher perceived usefulness (β=.414; P<.001), unemployment (β=-.155; P=.03), and positive illness perception (β=-.205; P=.004) were associated with a significantly higher rate of telehealth service use. Regarding the relationship between telehealth service use and health outcomes, higher rates of telehealth service use were linked to better quality of life (β=.241; P=.002) and lower peritonitis (odds ratio 0.980, 95% CI 0.962-0.997; P=.03).

CONCLUSIONS: This study provides valuable insights into factors impacting telehealth service use, which in turn affect health outcomes in patients undergoing CAPD.

PMID:38051557 | DOI:10.2196/48623

Blood Adv. 2023 Nov 16:bloodadvances.2023011489. doi: 10.1182/bloodadvances.2023011489. Online ahead of print.

ABSTRACT

During the manufacturing period of autologous chimeric antigen receptor (CAR) T cell therapy, patients may experience a decline in their condition due to cancer progression. In this study, we investigated the impact of “bridging therapy” (BT) on the outcome of patients with relapsed/refractory large B cell lymphoma who received anti-lymphoma treatment between leukapheresis and axicabtagene ciloleucel (axi-cel) infusion. We conducted our analysis using data from the multicenter US Lymphoma CAR T Consortium, with a median follow-up of 33 months (range: 4.3-42.1). Out of the 298 patients who underwent leukapheresis, 275 patients received axi-cel. The 52% (n=143) of patients who received BT had a higher baseline risk profile compared to patients who did not receive BT and these patients as a group had inferior outcomes than those who did not have BT. However, after propensity score matching between the two groups, there was no statistically significant differences in ORR (77% vs 87%, p=0.13), CR rate (58% vs 70%, p=0.1), PFS (HR=1.25, p=0.23), and OS (HR=1.39, p=0.09) between BT group and no BT group respectively. Analyzing effects of BT in the whole leukapheresed cohort regardless of receiving axi-cel (intention to treat analysis) showed similar results. Bridging radiation therapy resulted in outcomes similar to those observed with non-radiation BT. Our findings suggest that BT may be safe without a significant impact on long-term survival in patients who require disease stabilization during the manufacturing period. Moreover, our results suggest that there is no clear advantage in using radiation-based BT over non-radiation-based BT.

PMID:38051550 | DOI:10.1182/bloodadvances.2023011489

JAMA Netw Open. 2023 Dec 1;6(12):e2346121. doi: 10.1001/jamanetworkopen.2023.46121.

ABSTRACT

IMPORTANCE: Trial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available.

OBJECTIVE: To develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials.

EVIDENCE REVIEW: The SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist.

FINDINGS: This SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed.

CONCLUSIONS AND RELEVANCE: In this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial’s utility and transparency.

PMID:38051535 | DOI:10.1001/jamanetworkopen.2023.46121

JAMA Netw Open. 2023 Dec 1;6(12):e2346085. doi: 10.1001/jamanetworkopen.2023.46085.

ABSTRACT

IMPORTANCE: The association between sleep duration and all-cause mortality remains unclear among people with obstructive sleep apnea (OSA).

OBJECTIVE: To explore whether there is an association between sleep duration and all-cause mortality among people with OSA.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study investigated participants with OSA from the Sleep Heart Health Study (SHHS) in which participants were enrolled between 1995 and 1998 with questionnaires and polysomnography (PSG) assessment and followed up for a median of 11.8 years. SHHS was a multicenter community-based study; 2574 participants with OSA defined by apnea-hypopnea index (AHI) greater than or equal to 15 from SHHS were found; all of them had all-cause mortality data and were included in the study. Data were analyzed from November 2022 to October 2023.

EXPOSURES: Participants were divided into 4 groups with objective sleep duration of (1) at least 7 hours, (2) 6 to less than 7 hours, (3) 5 to less than 6 hours, and (4) less than 5 hours, which was determined by total sleep time on PSG at baseline.

MAIN OUTCOMES AND MEASURES: All-cause mortality was defined as deaths from any cause and its risk was compared among 4 OSA groups using Cox regression models.

RESULTS: A total of 2574 participants with OSA were included (1628 [63.2%] men and 946 [36.8%] women; mean [SD] age, 65.4 [10.7] years; 211 [8.2%] Black, 2230 [86.6%] White, 133 [5.2%] other race). Overall, 688 all-cause deaths were observed in participants. Compared with the group sleeping at least 7 hours, the groups sleeping 6 to less than 7 hours (hazard ratio [HR], 1.53 [95% CI, 1.13-2.07]), 5 to less than 6 hours (HR, 1.40 [95% CI, 1.03-1.90]), and less than 5 hours (HR, 1.64 [95% CI, 1.20-2.24]) had significantly higher risks of all-cause mortality independent of AHI. Sensitivity analyses were performed among participants with available data of positive airway pressure treatment during follow-up and the finding was mostly consistent, albeit the HR for the group of 5 to less than 6 hours was not statistically significant.

CONCLUSIONS AND RELEVANCE: In this cohort study of 2574 participants with OSA, those with shorter objective sleep duration had higher risk of all-cause mortality independent of AHI compared with those sleeping at least 7 hours. Further studies would be needed to investigate health benefits of extending sleep length among people with OSA with short sleep duration.

PMID:38051532 | DOI:10.1001/jamanetworkopen.2023.46085

JAMA Netw Open. 2023 Dec 1;6(12):e2346223. doi: 10.1001/jamanetworkopen.2023.46223.

ABSTRACT

IMPORTANCE: Patients with breast cancer and comorbid HIV experience higher mortality than other patients with breast cancer.

OBJECTIVE: To compare time to cancer treatment initiation and relative dose intensity (RDI) of neoadjuvant and adjuvant chemotherapy among patients with breast cancer with vs without HIV.

DESIGN, SETTING, AND PARTICIPANTS: A retrospective, matched cohort study enrolled women who received a diagnosis of breast cancer from January 1, 2000, through December 31, 2018. The electronic medical records of 3 urban, academic cancer centers were searched for women with confirmed HIV infection prior to or simultaneous with diagnosis of stage I to III breast cancer. Tumor registry data were used to identify 2 control patients with breast cancer without HIV for each participant with HIV, matching for study site, stage, and year of cancer diagnosis. Statistical analysis was performed from December 2022 to October 2023.

EXPOSURE: HIV infection detected before or within 90 days of participants’ breast cancer diagnosis.

MAIN OUTCOMES AND MEASURES: The primary outcome was time to breast cancer treatment initiation, defined as the number of days between cancer diagnosis and first treatment. The secondary outcome was overall RDI for patients who received chemotherapy. These outcomes were compared by HIV status using Cox proportional hazards regression and linear regression modeling, respectively, adjusting for confounding demographic and clinical factors. Exploratory outcomes included instances of anemia, neutropenia, thrombocytopenia, and liver function test result abnormalities during chemotherapy, which were compared using Fisher exact tests.

RESULTS: The study enrolled 66 women with comorbid breast cancer and HIV (median age, 51.1 years [IQR, 45.7-58.2 years]) and 132 with breast cancer alone (median age, 53.9 years [IQR, 47.0-62.5 years]). The median time to first cancer treatment was not significantly higher among patients with HIV than those without (48.5 days [IQR, 32.0-67.0 days] vs 42.5 days [IQR, 25.0-59.0 days]; adjusted hazard ratio, 0.78, 95% CI, 0.55-1.12). Among the 36 women with HIV and 62 women without HIV who received chemotherapy, the median overall RDI was lower for those with HIV vs without HIV (0.87 [IQR, 0.74-0.97] vs 0.96 [IQR, 0.88-1.00]; adjusted P = .01). Grade 3 or higher neutropenia during chemotherapy occurred among more women with HIV than those without HIV (13 of 36 [36.1%] vs 5 of 58 [8.6%]).

CONCLUSIONS AND RELEVANCE: This matched cohort study suggests that patients with breast cancer and HIV may have experienced reduced adjuvant chemotherapy RDI, reflecting greater dose reductions, delays, or discontinuation. Strategies for supporting this vulnerable population during chemotherapy treatment are necessary.

PMID:38051529 | DOI:10.1001/jamanetworkopen.2023.46223

J Acoust Soc Am. 2023 Dec 1;154(6):3627-3643. doi: 10.1121/10.0022577.

ABSTRACT

Hearing aids show more benefit in traditional laboratory speech-in-noise tests than in real-world noisy environments. Real-world noise comprises a large range of acoustic properties that vary randomly and rapidly between and within environments, making quantifying real-world noise and using it in experiments and clinical tests challenging. One approach is to use acoustic features and statistics to quantify acoustic properties of real-world noise and control for them or measure their relationship to listening performance. In this study, the complexity of real-world noise from different environments was quantified using entropy in both the time- and frequency-domains. A distribution of noise segments from low to high entropy were extracted. Using a trial-by-trial design, listeners with normal hearing and hearing loss (in aided and unaided conditions) repeated back sentences embedded in these noise segments. Entropy significantly affected speech perception, with a larger effect of entropy in the time-domain than the frequency-domain, a larger effect for listeners with normal hearing than for listeners with hearing loss, and a larger effect for listeners with hearing loss in the aided than unaided condition. Speech perception also differed between most environment types. Combining entropy with the environment type improved predictions of speech perception above the environment type alone.

PMID:38051522 | DOI:10.1121/10.0022577

Ann Ital Chir. 2023;94:478-482.

ABSTRACT

BACKGROUND: The inguinal hernia is the protrusion of intra-abdominal contents through a defect of the abdominal wall. This content can be represented by omentum, most frequently intestine. Theoretically, any intraperitoneal organ can be located in the hernia sac.The inguinal hernia is distinguished by several features: it is the most common form of hernia, it can occur in any age category, the only treatment is the surgical treatment, in the absence of the treatment, severe complications can endanger the patient’s life.The treatment of hernias consists either in the use of a classical (“open”) surgical procedure or of a laparoscopic procedure. The objective of both procedures is to remove and treat the hernia sac and repair the defect that appeared in the posterior wall of the groin canal.

OBJECTIVES: The purpose of this study is to compare the effectiveness of the two surgery types, considering the immediate postoperative pain.

METHODS: This paper is a prospective study conducted between September 2019 and February 2020, including a number of 80 patients admitted in the Department of General Surgery I and II, Emergency Clinical County Hospital of Târgu Mureș. In the study were included patients with uncomplicated inguinal hernia for which a classical or laparoscopic procedure was performed. Patients with complicated inguinal hernia (strangulation, incarceration) and patients with associated comorbidities (neoplasms, autoimmune diseases, neurological disorders) were excluded. For the study group were taken into consideration: demographic data (age, gender), type of surgery and the pain assessment using the VAS scale.

RESULTS: Following the study, it was statistically confirmed the prevalence of elderly patients to the detriment of young patients in both classical and laparoscopic study group. As we age, the pain sensitivity decreases, an aspect highlighted in the classical study group, the statistics showing the presence of less pain in elderly patients on the second postoperative day compared to young patients. Regarding the pain in both postoperative days, it was statistically proved that the pain tends to decrease in intensity on the second postoperative day compared to the first postoperative day.

CONCLUSIONS: As seen from this paper, taking into consideration the pain aspect, the two surgeries are very similar. Regardless of the chosen type of procedure, a preponderance of elderly patients was observed. The “Open Tension Free” procedure is a modern and efficient technique due to the absence of the local tension that can generate recurrence. The laparoscopic procedure has the advantage of reducing surgical trauma and minimizing recurrences. In the end, the type of treatment should be chosen by the surgeon after taking into consideration the type of hernia, the age and the patient’s comorbidities and the economic considerations.

KEY WORDS: Classical procedure, Inguinal hernia, Laparoscopic procedure.

PMID:38051514

Ann Ital Chir. 2023;94:483-492.

ABSTRACT

INTRODUCTION: Laparoscopic approach for inguinal hernia offers considerable advantages. Several risk factors for postoperative pain have been investigated, but few articles can be found about learning curve and surgeon’s influence on postoperative pain after inguinal herniorrhaphy.

PATIENTS AND METHODS: A prospective study was conducted including 105 patients. Surgical procedures were performed by two general surgeons performing TAPP procedure. Follow up was realized at one and three months after surgery.

RESULTS: Majority of investigated data were without significant differences. In case of the Senior Surgeon we registered higher SEI (surgeon experience index), increased proportion of bilateral inguinal hernias (P = 0.0309) and higher percentage of longer surgical procedures (P = 0.0309). Meantime in case of the Junior Surgeon we recorded operations with intermediate duration (P = 0.0232) in a greater manner. During the follow up period, similar incidence of pain senzation was remarked among patients, without statistical significance.

CONCLUSION: With adequate learning program and supervision TAPP procedure can be a safe technique when performed by young specialist too, presenting similar postoperative results with those of experienced surgeons.

KEY WORDS: Inguinal hernia, TAPP, Selfgripping surgical mesh, Postoperative pain.

PMID:38051509