Audit of the Medical Audit Committee.

We reviewed 39 medical audits started in one institution between 1981 and 1985 to determine whether they monitored the quality of health care in a scientific manner, whether recommendations were made that could improve the quality of health care and, if so, whether the recommendations were acted on. Thirty-three audits (85%) were completed; 21 (64%) failed to state their objectives, 30 (91%) failed to compare their results with those in the literature, 9 (27%) made no recommendations that could improve the quality of health care, and 9 were poorly researched and written. The number of patients in each audit was usually adequate. Feedback was rarely received by the Medical Audit Committee concerning the Medical Advisory Committee''s response to the audit. Information concerning the implementation of recommendations was available for 17 of the 24 audits that made recommendations; 7 (41%) had failed to implement half or more of the recommendations. Despite these problems, 8 (24%) of the audits were considered to be of a quality that could improve health care. We present recommendations to improve the audit procedure and foster the growing confidence among doctors in the medical audit.     

Results from an Audit Feedback Strategy for Chronic Obstructive Pulmonary Disease In-Hospital Care: A Joint Analysis from the AUDIPOC and European COPD Audit Studies

Background

Clinical audits have emerged as a potential tool to summarize the clinical performance of healthcare over a specified period of time. However, the effectiveness of audit and feedback has shown inconsistent results and the impact of audit and feedback on clinical performance has not been evaluated for COPD exacerbations. In the present study, we analyzed the results of two consecutive nationwide clinical audits performed in Spain to evaluate both the in-hospital clinical care provided and the feedback strategy.

Methods

The present study is an analysis of two clinical audits performed in Spain that evaluated the clinical care provided to COPD patients who were admitted to the hospital for a COPD exacerbation. The first audit was performed from November–December 2008. The feedback strategy consisted of personalized reports for each participant center, the presentation and discussion of the results at regional, national and international meetings and the creation of health-care quality standards for COPD. The second audit was part of a European study during January and February 2011. The impact of the feedback strategy was evaluated in term of clinical care provided and in-hospital survival.

Results

A total of 94 centers participated in the two audits, recruiting 8,143 admissions (audit 1∶3,493 and audit 2∶4,650). The initially provided clinical care was reasonably acceptable even though there was considerable variability. Several diagnostic and therapeutic procedures improved in the second audit. Although the differences were significant, the degree of improvement was small to moderate. We found no impact on in-hospital mortality.

Conclusions

The present study describes COPD hospital care in Spanish hospitals and evaluates the impact of peer-benchmarked, individually written and group-oral feedback strategy on the clinical outcomes for treating COPD exacerbations. It describes small to moderate improvements in the clinical care provided to COPD patients with no impact on in-hospital mortality.     

Clinical audits in a postgraduate general practice training program: an evaluation of 8 years' experience

Background

Clinical audit can be of valuable assistance to any program which aims to improve the quality of health care and its delivery. Yet without a coherent strategy aimed at evaluating audits'' effectiveness, valuable opportunities will be overlooked. Clinical audit projects are required as a part of the formative assessment of trainees in the Family Medicine Residency Program (FMRP) in Kuwait. This study was undertaken to draw a picture of trainees'' understanding of the audit project with attention to the knowledge of audit theory and its educational significance and scrutinize the difficulties confronted during the experience.

Methodology/Principal Findings

The materials included the records of 133 audits carried out by trainees and 165 post course questionnaires carried out between 2004 and 2011. They were reviewed and analyzed. The majority of audit projects were performed on diabetic (44.4%) and hypertensive (38.3%) care. Regarding audits done on diabetic care, they were carried out to assess doctors'' awareness about screening for smoking status (8.6%), microalbuminuria (19.3%), hemoglobin A1c (15.5%), retinopathy (10.3%), dyslipidemia (15.8%), peripheral neuropathy (8.8%), and other problems (21.7%). As for audits concerning hypertensive care, they were carried out to assess doctors'' awareness about screening for smoking status (38.0%), obesity (26.0%), dyslipidemia (12.0%), microalbuminuria (10.0%) and other problems (14.0%). More than half the participants (68.48%) who attended the audit course stated that they ‘definitely agreed’ about understanding the meaning of clinical audit. Most of them (75.8%) ‘definitely agreed’ about realizing the importance of clinical audit in improving patients'' care. About half (49.7%) of them ‘agreed’ that they can distinguish between ‘criteria’ and ‘standards’.

Conclusion

The eight years of experience were beneficial. Trainees showed a good understanding of the idea behind auditing the services provided. They demonstrated their ability to improve the care given in health centers in which these projects were undertaken.     

Clinical governance implementation in a selected teaching emergency department: a systems approach

ABSTRACT: BACKGROUND: Clinical governance (CG) is among the different frameworks proposed to improve the quality of healthcare. Iran, like many other countries, has put healthcare quality improvement in its top health policy priorities. In November 2009, implementation of CG became a task for all hospitals across the country. However, it has been a challenge to clarify the notion of CG and the way to implement it in Iran. The purpose of this action research study is to understand how CG can be defined and implemented in a selected teaching emergency department (ED).Methods/designWe will use Soft Systems Methodology for both designing the study and inquiring into its content. As we considered a complex problem situation regarding the quality of care in the selected ED, we initially conceptualized CG as a cyclic set of purposeful activities designed to explore the situation and find relevant changes to improve the quality of care. Then, implementation of CG will conceptually be to carry out that set of purposeful activities. The activities will be about: understanding the situation and finding out relevant issues concerning the quality of care; exploring different stakeholders' views and ideas about the situation and how it can be improved; and defining actions to improve the quality of care through structured debates and development of accommodations among stakeholders. We will flexibly use qualitative methods of data collection and analysis in the course of the study. To ensure the study rigor, we will use different strategies. DISCUSSION: Successful implementation of CG, like other quality improvement frameworks, requires special consideration of underlying complexities. We believe that addressing the complex situation and reflections on involvement in this action research will make it possible to understand the concept of CG and its implementation in the selected setting. By describing the context and executed flexible methods of implementation, the results of this study would contribute to the development of implementation science and be employed by boards and executives governing other clinical settings to facilitate CG implementation.     

Auditing audits: use and development of the Oxfordshire Medical Audit Advisory Group rating system.

OBJECTIVES--To assess the value of the Oxfordshire Medical Audit Advisory Group rating system in monitoring and stimulating audit activity, and to implement a development of the system. DESIGN--Use of the rating system for assessment of practice audits on three annual visits in Oxfordshire; development and use of an "audit grid" as a refinement of the system; questionnaire to all medical audit advisory groups in England and Wales. SETTING--All 85 general practices in Oxfordshire; all 95 medical audit advisory groups in England and Wales. MAIN OUTCOME MEASURES--Level of practices'' audit activity as measured by rating scale and grid. Use of scale nationally together with perceptions of strengths and weaknesses as perceived by chairs of medical audit advisory groups. RESULTS--After one year Oxfordshire practices more than attained the target standards set in 1991, with 72% doing audit involving setting target standards or implementing change; by 1993 this had risen to 78%. Most audits were confined to chronic disease management, preventive care, and appointments. 38 of 92 medical audit advisory groups used the Oxfordshire group''s rating scale. Its main weaknesses were insensitivity in assessing the quality of audits and failure to measure team involvement. CONCLUSIONS--The rating system is effective educationally in helping practices improve and summatively for providing feedback to family health service authorities. The grid showed up weakness in the breadth of audit topics studied. IMPLICATIONS AND ACTION--Oxfordshire practices achieved targets set for 1991-2 but need to broaden the scope of their audits and the topics studied. The advisory group''s targets for 1994-5 are for 50% of practices to achieve an audit in each of the areas of clinical care, access, communication, and professional values and for 80% of audits to include setting targets or implementing change.     

Protocol for Development of American Association of Clinical Endocrinology Clinical Practice Guidelines and Consensus Statements: Summary of Methodology,Process, and Policy – 2023 Update

ObjectiveThis 2023 updated protocol summarizes the American Association of Clinical Endocrinology’s (AACE’s) new framework for the development of clinical practice guidelines and other guidance documents that includes changes to methodology, processes, and policies.MethodsAACE has critically reviewed its development processes for guidance documents over the last several years against the National Academy of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines and the Council of Medical Specialty Societies Principles for Development of Specialty Society Clinical Guidelines to determine areas for improvement.ResultsThe new AACE framework for development of guidance documents incorporates many changes, including a revised conflicts of interest (COI) policy; strengthened commitment to collection of disclosures and management of relevant COI during development; open calls to membership for authors; new requirements for authors; new diversity, equity, and inclusion (DEI) policy; new empanelment process that incorporates consideration of DEI; and adoption of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to increase the quality of evidence assessment and standardize recommendation grades and statements, among other improvements.ConclusionsAACE has revised its policies and adopted a completely new methodology for guideline development in support of the mission to elevate the practice of clinical endocrinology to improve patient care. With the use of an evidence-based medicine framework and by continually assessing and improving its processes for development of guidance, AACE strives to deliver trustworthy, unbiased, and up-to-date information that ensures clinician and patient confidence in AACE content. Further, AACE hopes that these enhancements foster a more collaborative approach to development and increase engagement with the worldwide medical community to improve global health.     

Quality control of human tissues-experience from the Indiana University Cancer Center-Lilly Research Labs human tissue bank

The success of molecular research and its applications in both the clinical and basic research arenas is strongly dependent on the collection, handling, storage, and quality control of fresh human tissue samples. This tissue bank was set up to bank fresh surgically obtained human tissue using a Clinical Annotated Tissue Database (CATD) in order to capture the associated patient clinical data and demographics using a one way patient encryption scheme to protect patient identification. In this study, we determined that high quality of tissue samples is imperative for both genomic and proteomic molecular research. This paper also contains a brief compilation of the literature involved in the patient ethics, patient informed consent, patient de-identification, tissue collection, processing, and storage as well as basic molecular research generated from the tissue bank using good clinical practices. The current applicable rules, regulations, and guidelines for handling human tissues are briefly discussed. More than 6,610 cancer patients have been consented (97% of those that were contacted by the consenter) and 16,800 tissue specimens have been banked from these patients in 9 years. All samples collected in the bank were QC’d by a pathologist. Approximately 1,550 tissue samples have been requested for use in basic, clinical, and/or biomarker cancer research studies. Each tissue aliquot removed from the bank for a research study were evaluated by a second H&E, if the samples passed the QC, they were submitted for genomic and proteomic molecular analysis/study. Approximately 75% of samples evaluated were of high histologic quality and used for research studies. Since 2003, we changed the patient informed consent to allow the tissue bank to gather more patient clinical follow-up information. Ninety two percent of the patients (1,865 patients) signed the new informed consent form and agreed to be re-contacted for follow-up information on their disease state. In addition, eighty five percent of patients (1,584) agreed to be re-contacted to provide a biological fluid sample to be used for biomarker research.     

我国心血管专科临床科研数据中心的建设与思考

中国是心血管疾病的数据大国,但是从数据质量和临床科研上讲,并非强国。为了提高心血管数据在临床质量评估和科研中的应用,我院心内科开始了心血管专科临床科研数据中心的尝试和建设。通过借鉴美国相关经验,以及对我国心血管临床质量评估以及科研需求的深入调研,我们建设了以心血管专科临床数据仓库以及心血管注册数据中心为核心的心血管专科临床科研数据中心。在此基础上,进一步探索并建设了自定义科研表单,多维度组合筛选,基于随访策略的心血管随访管理,基于个性化诊疗计划的心血管病人院后管理,相关性分析及不良心血管事件模式发现等应用和工具,有助于提升心血管专科的临床流程效率,临床质量评估和科研水平,同时为建立全国性的心血管疾病注册数据库打下了基础。     

Considerations in the construction of an instrument to assess attitudes regarding critical illness gene variation research

Clinical studies conducted in intensive care units are associated with logistical and ethical challenges. Diseases investigated are precipitous and life-threatening, care is highly technological, and patients are often incapacitated and decision-making is provided by surrogates. These investigations increasingly involve collection of genetic data. The manner in which the exigencies of critical illness impact attitudes regarding genetic data collection is unstudied. Given interest in understanding stakeholder preferences as a foundation for the ethical conduct of research, filling this knowledge gap is timely. The conduct of opinion research in the critical care arena is novel. This brief report describes the development of parallel patient/surrogate decision-maker quantitative survey instruments for use in this environment. Future research employing this instrument or a variant of it with diverse populations promises to inform research practices in critical illness gene variation research.     

Clinical guidelines contribute to the health inequities experienced by individuals with intellectual disabilities

ABSTRACT: BACKGROUND: Clinical practice guidelines are developed to improve the quality of healthcare. However, clinical guidelines may contribute to health inequities experienced by disadvantaged groups. This study uses an equity lens developed by the International Clinical Epidemiology Network (INCLEN) to examine how well clinical guidelines address inequities experienced by individuals with intellectual disabilities. METHODS: Nine health problems relevant to the health inequities experienced by persons with intellectual disabilities were selected. Clinical guidelines on these disorders were identified from across the world. The INCLEN equity lens was used as the basis for a purposedesigned, semistructured data collection tool. Two raters independently examined each guideline and completed the data collection tool. The data extracted by each rater were discussed at a research group consensus conference and agreement was reached on a final equity lens rating for each guideline. RESULTS: Thirty-six guidelines were identified, one of which (2.8%) explicitly excluded persons with intellectual disabilities. Of the remaining 35, six (17.1%) met the first criterion of the equity lens, identifying persons with intellectual disabilities at high risk for the specific health problem. Eight guidelines (22.9%) contained any content on intellectual disabilities. Six guidelines addressed the fourth equity lens criterion, by giving specific consideration to the barriers to implementation of the guideline in disadvantaged populations. There were no guidelines that addressed the second, third, and fifth equity lens criteria. CONCLUSIONS: The equity lens is a useful tool to systematically examine whether clinical guidelines address the health needs and inequities experienced by disadvantaged groups. Clinical guidelines are likely to further widen the health inequities experienced by persons with intellectual disabilities, and other disadvantaged groups, by being preferentially advantageous to the general population. There is a need to systematically incorporate methods to consider disadvantaged population groups into the processes used to develop clinical guidelines.     

Auditing audits: the method of Oxfordshire Medical Audit Advisory Group.

OBJECTIVES--To develop a systematic method for both summative and formative audit of practice audits, and to use the method to review Oxfordshire practice audits and to plan improvement. DESIGN--Development of a coding system for the audit cycle subsequently used prospectively to assess audits reported to medical audit advisory group coordinators on practice visits. SETTING--All 85 general practices in Oxfordshire, of which 80 were visited by Oxfordshire Medical Audit Advisory Group coordinators. MAIN OUTCOME MEASURES--Satisfaction of criteria for different levels of audit (full, partial, potential, planning or no audit) according to coding scores for practice audits. RESULTS--46 (58%) practices were classified as doing audit, the remainder doing no audit or only collecting data for family health services authority returns. Of audits being undertaken, 55/102 (54%) included planning care or the setting of targets. CONCLUSIONS--The coding system offers the prospect of formative assessment for practices to help them improve their audits, and summative assessment for the family health services authority to satisfy the needs for professional accountability. Its use in Oxfordshire disclosed considerable deficiencies in the process of practice audit. IMPLICATIONS AND ACTION--Practices in Oxfordshire should improve their audits. The advisory groups target to March 1992 is for 50% of practices to be doing full or partial and 25% potential audit and half of the remainder planning audit. Practices are encouraged to include in their audit implementing change, planning care, and agreeing criteria for further assessment.     

The effectiveness of an aged care specific leadership and management program on workforce,work environment,and care quality outcomes: design of a cluster randomised controlled trial

Background

A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care???CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program.

Methods

Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster-level analysis. The overall costs and benefits of the program will also be assessed.

Discussion

The outcomes of the trial have the potential to inform actions to enhance leadership and management capabilities of the aged care workforce, address pressing issues about workforce shortages, and increase the quality of aged care services.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN12611001070921)

     

Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists

Background

Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem.

Methods And Findings

We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden.

Conclusions

Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.     

Improving case ascertainment of a population-based birth defects registry in New York State using hospital discharge data

BACKGROUND: The assessment of the data quality of population-based registration systems is essential to understanding the reliability and usefulness of disease surveillance and research findings resulting from the use of registry data. Since the New York State Congenital Malformations Registry (CMR) uses passive case ascertainment, the completeness of the registry data is an important aspect of the quality of information. This paper presents the results of hospital audits, which were conducted to capture the unreported cases using hospital discharge files, and evaluates the effectiveness of the audits. METHODS: Children age 2 years or younger and diagnosed with reportable birth defects for the birth years 1998-2000 were selected from hospital discharge files of all reporting hospitals in the New York Statewide Planning and Research Cooperative System (SPARCS) and matched to the CMR database for the same birth year period.The unmatched reports from the SPARCS hospital discharge files that the CMR possibly missed were sent to hospitals, requesting submission of the missed reports. Two audits on all reporting hospitals in New York State were conducted: 1) 1998 and 1999 birth cohorts audited from June 2000 to March 2002, and 2) 2000 birth cohort audited from November 2001 to November 2002. RESULTS: Hospital audits using SPARCS hospital discharge data identified 5,460 reports that the CMR missed for the selected 66 hospitals analyzed. About 86% of these reports had reportable conditions and were added to the CMR, which comprised 21.4% of all reports from the 66 hospitals for the birth years 1998-2000. The number of reports that would have been missed without audits decreased from the 1998 and 1999 birth cohort (25.1%) to the 2000 birth cohort (13.9%). Low reporting rates and, thus, a high percent of added reports, were found for hospitals with a relatively small number of annual reports and for some specific birth defects such as chromosomal anomalies, anencephalus and congenital anomalies of the urinary system. CONCLUSION: The current study demonstrates that using hospital discharge data to improve case ascertainment is a valuable and effective method of enhancing birth defect surveillance, particularly for those hospitals with low reporting rates.     

Spatial and temporal patterns of intraspecific morphological variation in Dactylogyrus simplexus from fathead minnows in Nebraska

Dactylogyrus simplexus Monaco and Mizelle, 1955, occurs on the gills of fathead minnows (Pimephales promelas). Previous research on parasites of fathead minnows from 3 converging Nebraska streams, Elk Creek, Oak Creek, and West Oak Creek, shows that fish in each stream constitute distinct populations. To determine whether their parasites had diverged structurally in response to such isolation, or in response to seasonal change, we searched for patterns of intraspecific morphometric variation among D. simplexus. Over 3 collection dates in fall 2007, spring 2008, and fall 2009, 203 D. simplexus were collected from Elk and West Oak Creeks. We ran 1-way ANOVA to compare differences in 15 distinct point-to-point measurements of sclerotized parts across sites and collection dates. Significant differences were found in some D. simplexus measurements between Elk and West Oak Creeks for all 3 collection dates, but the characteristics that differed and the trend of variation between the creeks were not consistent over time. Dactylogyrus simplexus from both Elk and West Oak Creeks showed consistent patterns of variation over time for 5 measurements, including hamulus gap width, bar length, marginal hook length, sickle length, and sickle width. In conclusion, D. simplexus demonstrate consistent patterns of seasonal variation, but not spatial.     

Proposals to enhance the quality of observational cohort studies

For herbal medicinal products the methodology of observational cohort studies (observational studies, drug monitoring studies, Anwendungsbeobachtung) represents a useful addition to clinical trials. The key objectives are the documentation of efficacy in particular under conditions of everyday medical practice in authentic patients and the documentation of the safety profile. Supplementary to earlier activities, members of the "Clinical Trials of Herbal Medicinal Products" Working Party of the German Society for Phytotherapy have therefore again addressed the issue of observational cohort studies for to enhance the informative value and importance of this clinical research methodology. Recommendations were developed on quality aspects, methodological approaches of observation parameters, and for the reporting of the study's results. Properly planned and conducted observational cohort studies may contribute to the documentation and proof of well-established medicinal use according the EU Directive 2001/83/EC.     

‘I Know that I Do Have HIV but Nobody Saw Me’: Oral HIV Self-Testing in an Informal Settlement in South Africa

Reaching universal HIV-status awareness is crucial to ensure all HIV-infected patients access antiretroviral treatment (ART) and achieve virological suppression. Opportunities for HIV testing could be enhanced by offering self-testing in populations that fear stigma and discrimination when accessing conventional HIV Counselling and Testing (HCT) in health care facilities. This qualitative research aims to examine the feasibility and acceptability of unsupervised oral self-testing for home use in an informal settlement of South Africa. Eleven in-depth interviews, two couple interviews, and two focus group discussions were conducted with seven healthcare workers and thirteen community members. Thematic analysis was done concurrently with data collection. Acceptability to offer home self-testing was demonstrated in this research. Home self-testing might help this population overcome barriers to accepting HCT; this was particularly expressed in the male and youth groups. Nevertheless, pilot interventions must provide evidence of potential harm related to home self-testing, intensify efforts to offer quality counselling, and ensure linkage to HIV/ART-care following a positive self-test result.