{"title":"From Compliance to Excellence: How Can ISO 13485 Standards Transform Quality, Safety and Innovation in Medical Devices?","authors":"Usman Iqbal, Peter Lachman, Phillip Phan","doi":"10.1093/intqhc/mzaf032","DOIUrl":"https://doi.org/10.1093/intqhc/mzaf032","url":null,"abstract":"","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"In Good Hands: Exploring patient safety in the Philippines.","authors":"Dalmacito A Cordero","doi":"10.1093/intqhc/mzaf031","DOIUrl":"https://doi.org/10.1093/intqhc/mzaf031","url":null,"abstract":"","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jared Chiu, Vahid Sarhangian, Sarah Tosoni, Laura Danielle Pozzobon, Lucas B Chartier
{"title":"Associations of Hospital Unit Occupancy with Inpatient Falls and Fall-Risk Assessment Completion: A Retrospective Cohort Study.","authors":"Jared Chiu, Vahid Sarhangian, Sarah Tosoni, Laura Danielle Pozzobon, Lucas B Chartier","doi":"10.1093/intqhc/mzaf028","DOIUrl":"https://doi.org/10.1093/intqhc/mzaf028","url":null,"abstract":"<p><strong>Background: </strong>Inpatient fall assessment and prevention efforts are primarily performed by nursing teams. Operating at high occupancy levels may therefore reduce the care team's ability to deliver these efforts in a timely and effective way. We investigated the associations of unit-level hospital occupancy with the rate of inpatient fall and the completion of patient fall-risk assessment.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using data from a large teaching hospital network in Ontario, between 2017-2020. We used a multi-state semi-Markov model to represent the time from admission to inpatient care to primary outcomes of first inpatient fall, and completion of fall-risk assessment in the presence of other competing events. Unit-level occupancy was defined as the time-dependent maximum ratio of unit census to unit capacity and further categorized based on whether it was below or above a given threshold or \"tipping point\". We estimated the tipping point as well as the association between unit-level occupancy below and above the tipping point with the cause-specific hazard rate of each outcome, adjusting the estimates for confounders.</p><p><strong>Results: </strong>The final cohort had 83,839 inpatient stays for the fall outcome and 83,853 inpatient stays for the fall-risk assessment outcome. Unit occupancy levels above the estimated tipping point of 95% were associated with an increased rate of falls [Hazard Ratio (HR): 2.10, 95% Confidence Interval (CI): 1.05, 4.20], whereas occupancy levels above the estimated tipping point of 77% were associated with a decreased rate of completion of fall-risk assessment [HR: 0.87, 95% CI: 0.82, 0.91].</p><p><strong>Conclusions: </strong>Our study provides evidence for a significant increase in the rate of falls and decrease in the rate of assessment completion when occupancy levels exceed certain tipping points. The results motivate the design of safety protocols tailored for periods of high-capacity strain to support nursing teams and prioritize delivery of assessments and interventions to patients at high risk of fall.</p>","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Improving primary care through multidisciplinary teamwork: possibilities and challenges.","authors":"Michael Kidd, Shona Marie Bates, David Greenfield","doi":"10.1093/intqhc/mzaf021","DOIUrl":"10.1093/intqhc/mzaf021","url":null,"abstract":"","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jacob Sessim Filho, Renato Palacio de Azevedo, Antonildes Nascimento Assunção, Marcia Martiniano de Sousa E Sá, Felipe Duarte Silva, Laerte Pastore Jnr, Luiz Francisco Cardoso, Fernando Ganem
{"title":"Dedicated Rapid Response Team Implementation Associated with Reductions in Hospital Mortality and Hospital Expenses: A Retrospective Cohort Analysis.","authors":"Jacob Sessim Filho, Renato Palacio de Azevedo, Antonildes Nascimento Assunção, Marcia Martiniano de Sousa E Sá, Felipe Duarte Silva, Laerte Pastore Jnr, Luiz Francisco Cardoso, Fernando Ganem","doi":"10.1093/intqhc/mzaf030","DOIUrl":"https://doi.org/10.1093/intqhc/mzaf030","url":null,"abstract":"<p><strong>Introduction: </strong>The clinical impact of the implementation of rapid response teams remains controversial in the literature. Furthermore, data on the financial impact of this intervention remain scarce. Therefore, we aim to assess the impact of the implementation of a dedicated RRT on hospital mortality and hospital expenses of patients experiencing acute clinical deterioration requiring an unplanned ICU admission.</p><p><strong>Methods: </strong>We conducted a retrospective single-centre cohort study of adult patients experiencing acute clinical deterioration requiring an unplanned ICU admission before and after the transition of the rapid response team leadership to a dedicated group on June 1, 2014. Admissions that occurred 30 days before and 30 days after were excluded because they included the training period of the team members. Therefore, the PRE group encompassed patients who required an unplanned ICU admission between May 1, 2012, and April 30, 2014, and the POST group included those admitted to the ICU between July 1, 2014, and June 30, 2016. Patients were matched by propensity score according to a calibration of 0.2 and at a 1:1 ratio using the nearest neighbour matching method. The primary outcome was in-hospital mortality, with secondary outcomes including intensive care unit mortality, hospital and intensive care unit length of stay, intensive care unit readmission rate within 48 hours, and hospital expenses.</p><p><strong>Results: </strong>The study included 977 consecutive patients: 470 in the PRE group and 507 in the POST group. Following propensity score matching, 343 pairs (totalling 686 patients) were identified. Analyses revealed reductions in in-hospital mortality rate (34.7% PRE vs. 22.7% POST; odds ratio 0.590 [95% CI: 0.254-0.927], P < 0.001) and intensive care unit mortality rate (19.5% PRE vs. 12.8% POST; odds ratio 0.501 [95% CI: 0.087-0.915]; P = 0.022). Decreases in hospital and intensive care unit length of stay and use of intensive care unit support measures were also observed, accompanied by a 23.2% reduction in hospital expenditure (P < 0.001).</p><p><strong>Conclusion: </strong>Transitioning to a dedicated rapid response team was associated with reduced in-hospital mortality and hospital resource utilisation. Future research in diverse settings and cost-effectiveness analyses are warranted to confirm these findings and explore the economic impacts of rapid response teams.</p>","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Disparities in the quality of care for adults with type 2 diabetes according to socioeconomic level and ethnicity in Mexico.","authors":"Sergio Flores-Hernández, Nadia Cerecer-Ortiz, Hortensia Reyes-Morales, Blanca Pelcastre-Villafuerte, Leticia Avila-Burgos","doi":"10.1093/intqhc/mzaf029","DOIUrl":"https://doi.org/10.1093/intqhc/mzaf029","url":null,"abstract":"<p><strong>Background: </strong>The quality and equitable accessibility of health services represent basic priorities for health systems. In Mexico, three quarters of patients with diabetes are treated at public health services shown to be heterogeneous as regards the quality of the health-care processes. This notwithstanding, no information has been published on the quality of care provided to patients with diabetes according to their socioeconomic characteristics and ethnicity. Accordingly, the objective of this study was to identify disparities in the quality of care provided to adults medically diagnosed with type 2 diabetes (T2D), according to their socioeconomic levels and ethnicity.</p><p><strong>Methods: </strong>Cross-sectional analysis based on data drawn from the 2018-19 National Health and Nutrition Survey. Quality of care was assessed from the patients' perspective. Analysis included a nationally representative sample of 4,555 adults aged ≥20 years, with a diagnosis of diabetes, and a subsample of 1,586 adults with Hb1Ac measurements. Two multiple linear regression models were fitted to assess the relationship between the overall quality of care provided vs. the socioeconomic levels and ethnicity of patients, adjusted for covariates.</p><p><strong>Results: </strong>Nearly one third of adults with diabetes belonged to low socioeconomic levels, 7% were indigenous, 92% were ≥40 years old, and 50% had experienced diabetes-related complications. Respondents had been diagnosed with diabetes for 11 years on average. Patients of low socioeconomic levels showed a higher frequency of complications and inadequate glycemic control than did those of higher levels. After adjusting for covariates, the quality of care received was poorer among T2D patients of low (-4.8 pp, 95% CI: -6.5, -3.0) and medium (-1.5 pp, 95% CI: -3.1,0.1) socioeconomic levels compared to those in the high tier, and among indigenous (-2.7 pp, 95% CI -5.3, -0.1) vs. non-indigenous individuals.</p><p><strong>Conclusions: </strong>Overall, adults with diabetes receive poor-quality health care. Furthermore, disparities exist by socioeconomic level and ethnicity in the quality of care provided. It is essential to strengthen and renew health-care policies with a view to improving outpatient care for individuals with diabetes, one of the most prevalent chronic diseases in Mexico and around the world. It is vital that efforts to ensure the health and well-being of the most socially vulnerable populations be rooted in an equity approach.</p>","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alexandra N Ryan, Kelvin L Robertson, Beverley D Glass
{"title":"Look-alike, sound-alike medication perioperative incidents in a regional Australian hospital: assessment using a novel medication safety culture assessment tool.","authors":"Alexandra N Ryan, Kelvin L Robertson, Beverley D Glass","doi":"10.1093/intqhc/mzaf018","DOIUrl":"10.1093/intqhc/mzaf018","url":null,"abstract":"<p><strong>Background: </strong>Medication safety remains a global concern, with governments and organizations striving to mitigate preventable patient harm across healthcare systems. Look-alike, sound-alike medication incidents and the safety culture are widely acknowledged as a contributor to medication errors, particularly within the high-risk perioperative environment. The Medication Safety Culture Indicator Matrix (MedSCIM) is a novel tool developed by the Canadian Institute for Safe Medication Practices to assess the maturity of the medication safety culture. This study aims to delineate look-alike sound-alike (LASA) medication incidents reported in the pharmacy and perioperative settings of an Australian hospital and assess the maturity of the medication safety culture.</p><p><strong>Methods: </strong>The study setting is within a large regional hospital in Australia, servicing both adult and paediatric populations. Medication incidents from 1 April 2018 to 1 April 2023 were retrospectively gathered from the Clinical Incident Management System, Riskman®. Data and statistical analyses were carried out using Microsoft Excel®. The necessary approvals were secured from the Heath Service Human Research and Ethics Committee.</p><p><strong>Results: </strong>During the 5-year period, a total of 246 (4.1%) of the 6002 medication incidents within the health service were identified as meeting the inclusion criteria. Of the 246 medication incidents, 63.0% were identified from the Pharmacy Department, while 22.0% and 15.0% were from the Post Anaesthetic Care Unit and Anaesthetics Department, respectively. The most frequently reported incident classification in both the Anaesthetics Department and Post Anaesthetic Care Unit was 'incorrect dose', followed by 'incorrect medication'. Throughout the 5-year period, 46 (18.7%) of the 246 medication incidents were attributed to look-alike, sound-alike sources of error, predominantly identified in the Pharmacy Department (73.9%), followed by the Anaesthetics Department (17.4%) and the Post Anaesthetic Care Unit (8.7%). High-risk medications were most frequently reported to the Anaesthetics Department. Packaging (packaging alone, naming and packaging, and syringe swaps) was determined to be a contributing factor in 30 (65.2%) of the 46 LASA medication incidents. MedSCIM assessment revealed a reactive medication safety culture. Additionally, the medication incident report documentation was found to be mostly complete or semi-complete.</p><p><strong>Conclusion: </strong>Our analysis delineated medication incidents occurring across the entire medication management cycle and identified incidents related to LASA medications as a contributor to medication incidents across these clinical settings. This novel medication safety culture tool assessment highlighted opportunities for improvement with clinical incident documentation.</p>","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11934547/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Harriet Bullen, Vasudha Wattal, Rachel Meacock, Matt Sutton
{"title":"Determinants of quality in the independent and public hospital sectors in England.","authors":"Harriet Bullen, Vasudha Wattal, Rachel Meacock, Matt Sutton","doi":"10.1093/intqhc/mzaf019","DOIUrl":"10.1093/intqhc/mzaf019","url":null,"abstract":"<p><strong>Background: </strong>Increasing the use of independent providers has been proposed as a solution to the long waiting times at public hospitals generated by the postpandemic backlog for elective care. However, the profit-maximizing aims of some independent providers may risk cost-cutting behaviours and reduced care quality. Empirical evidence on the extent to which these concerns are borne out in practice is sparse. We aim to examine the quality of acute hospital care provided by the public and independent hospital sectors in England and explore the drivers of variation in quality.</p><p><strong>Methods: </strong>We construct a unique dataset collating publicly available Care Quality Commission (CQC) quality ratings of independent and public acute hospitals as of December 2022 and 2020. We link these to regional deprivation indices, population estimates, average household disposable incomes, and referral to treatment (RTT) data. We first categorize providers into National Health Service (NHS) and independent hospitals to analyse the association of ownership with quality ratings. To analyse ownership further, we then subcategorize independent hospitals further and consider whether the organization provides NHS-commissioned care. Thus, hospitals were categorized into seven mutually exclusive categories: NHS provider, commissioned charity, commissioned brand, commissioned independent other, noncommissioned charity, noncommissioned brand, and noncommissioned independent other. We use linear and ordered logistic regression models to assess the association of ownership with quality ratings. In supplementary analysis, we examine consistency over time by comparing the effects on 2022 ratings and 2020 ratings.</p><p><strong>Results: </strong>Of the 283 NHS hospitals, 47.3% (N = 134) was rated 'Good' and 41.0% (N = 116) was rated as 'Requires Improvement'. Of the 453 independent hospitals, 82.3% (N = 373) was rated 'Good' and 9.5% (N = 43) was rated as 'Requires Improvement'. On average, independent hospitals had 0.205 (Standard Error [SE] = 0.0581) higher category quality ratings than NHS providers. All types of NHS-commissioned independent sector hospitals had higher average quality ratings than NHS hospitals, as did noncommissioned branded hospitals. Quality ratings were negatively related to the number of different services provided, suggesting that specialization is associated with higher quality.</p><p><strong>Conclusion: </strong>We find higher quality ratings for independent providers providing NHS-funded care, branded providers, and providers with a narrower range of services. We find no evidence to suggest that outsourced patients will experience lower quality care, although cream-skimming could still be detrimental for NHS services if they are left with a more complex case mix. Overall, our results taken together suggest that the increasing number of NHS patients treated in the independent sector does not experience a worse quality of ","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11932141/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michela Atzeni, Mauro Giovanni Carta, David Greenfield
{"title":"Creating transformative change in the disabilities field: promoting both bottom-up and top-down inclusion through the UNCRPD and QualityRights Toolkit.","authors":"Michela Atzeni, Mauro Giovanni Carta, David Greenfield","doi":"10.1093/intqhc/mzaf020","DOIUrl":"10.1093/intqhc/mzaf020","url":null,"abstract":"","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anita Lim, Bronwen Merner, Srividya Iyer, Michael McCullough
{"title":"Evaluation of temporomandibular disorder self-management apps in Australia: A systematic review to inform clinical use.","authors":"Anita Lim, Bronwen Merner, Srividya Iyer, Michael McCullough","doi":"10.1093/intqhc/mzaf024","DOIUrl":"https://doi.org/10.1093/intqhc/mzaf024","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to systematically evaluate apps with temporomandibular disorder (TMD) self-management content available in Australia for quality, clinical safety, self-management support functions, and contributors to app development.</p><p><strong>Methods: </strong>A systematic search of the App Store (iOS) and Google Play (Android) was conducted on 18 April 2023 (and updated 26 July 2023) to identify apps that had TMD self-management content. Two raters independently assessed app quality, clinical safety, self-management support, and contributors to app development for the involvement of people living with TMD and clinicians. Quality was evaluated using the Mobile App Rating Scale (MARS) for engagement, functionality, aesthetics, and information quality scored using a 5-point Likert scale. App clinical safety was assessed using MARS functionality (item 6) and information quality items for accuracy/relevance (item 15), scope (item 16), and visual information accuracy/clarity (item 17) (scored on a Likert scale), and the M-Health Index and Navigation Database framework questions: does the app provide any warning for use? Does the app have a crisis management feature? Can the app cause harm? (scored yes/no). Self-management support was evaluated using the Self-Management Support (SMS-14) checklist (scored yes/no). Included apps, app store descriptions and linked websites were qualitatively evaluated to determine the contributors to app development.</p><p><strong>Results: </strong>Seven apps with TMD self-management content were available in Australia. Overall, the included apps were of acceptable quality (mean=3.25/5) but scored poorly for engagement (2.71/5) and information (2.92/5). Clinical safety limitations identified were the inability to identify and/or direct users to support services in a crisis and inconsistent TMD information. One app (Do I Grind or Snore) was deemed potentially harmful as sleep sounds suggestive of obstructive sleep apnoea were interpreted as snoring by the app. Overall, the inclusion of self-management support functions was variable (range 1-9; mean=4.71/14), with pain/TMD education (71%) and self-monitoring (71%) the most common. Only one app had development input from a person with lived experience of TMD.</p><p><strong>Conclusion: </strong>The quality and self-management support of apps with TMD self-management content is variable. TMD apps with activating self-management strategies and higher engagement scores are more likely to be effective. Concerningly, one app was found to be potentially harmful, and overall apps lacked user safeguards. Only one app involved a person with TMD in its development, and the authors recommend using co-design in future TMD app development to improve app quality, clinical safety and impact.</p>","PeriodicalId":13800,"journal":{"name":"International Journal for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}