-
BMJ Open Dec 2022Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of...
INTRODUCTION
Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of surgical strategies including techniques and mesh types are available to manage patients with incisional hernia. Previous works have reported significant heterogeneity in outcome reporting for abdominal wall herniae, including ventral and inguinal hernia. This is coupled with under-reporting of important clinical and patient-reported outcomes. The lack of standardisation in outcome reporting contributes to reporting bias, hinders evidence synthesis and adequate data comparison between studies. This project aims to develop a core outcome set (COS) of clinically important, patient-oriented outcomes to be used to guide reporting of future research in incisional hernia.
METHODS
This project has been designed as an international, multicentre, mixed-methods project. Phase I will be a systematic review of current literature to examine the current clinical and patient-reported outcomes for incisional hernia and abdominal wall reconstruction. Phase II will identify the outcomes of importance to all key stakeholders through in depth qualitative interviews. Phase III will achieve consensus on outcomes of most importance and for inclusion into a COS through a Delphi process. Phase IV will achieve consensus on the outcomes that should be included in a final COS.
ETHICS AND DISSEMINATION
The adoption of this COS into clinical and academic practice will be endorsed by the American, British and European Hernia Societies. Its utilisation in future clinical research will enable appropriate data synthesis and comparison and will enable better clinical interpretation and application of the current evidence base. This study has been registered with the Core Outcome Measures in Effectiveness Trials initiative.
PROSPERO REGISTRATION NUMBER
CRD42018090084.
Topics: Humans; Incisional Hernia; Quality of Life; Outcome Assessment, Health Care; Hernia, Ventral; Research Design; Delphi Technique; Treatment Outcome; Systematic Reviews as Topic
PubMed: 36600359
DOI: 10.1136/bmjopen-2021-059463 -
Hepatology (Baltimore, Md.) Sep 2020Prevention of decompensation is a primary therapeutic target in patients with compensated cirrhosis (CC). However, a major problem is the large sample size and long...
BACKGROUND AND AIMS
Prevention of decompensation is a primary therapeutic target in patients with compensated cirrhosis (CC). However, a major problem is the large sample size and long follow-up required to demonstrate a significant treatment effect because of the relatively low baseline risk. For this reason, it has been recently suggested that ordinal outcomes may be used in this area to gain power and reduce sample size. The aim of this study was to assess the applicability of ordinal outcomes in cirrhosis.
APPROACH AND RESULTS
An inception cohort of 202 patients with CC (no ascites, gastrointestinal bleeding, encephalopathy, or jaundice) without esophageal varices was included, and 5-year outcome is reported. Etiology was mostly viral and alcoholic, and there were no dropouts. Ordinal outcome was set according to six grades with a previously established prognostic ordinality: grade 1 = no disease progression; grade 2 = development of varices; grade 3 = bleeding alone; grade 4 = nonbleeding single decompensation; grade 5 = more than one decompensating event; and grade 6 = death. At the 60-month time point, patients were distributed in grades 1 through 6 as follows: 129, 43, 2, 7, 5, and 16, respectively. Emulation of a clinical trial performed by dividing patients based on baseline platelet count into two groups (cutoff, 150 × 10 /L) demonstrated a statistically significant outcome difference between groups when using ordinal outcomes not detectable by binary logistic or chi-square or time-to-event analyses. Additionally, using ordinal outcomes in a hypothetical study to prevent decompensation resulted in sample-size estimates 3-to 4-fold lower than using a binary composite endpoint.
CONCLUSIONS
Compared to traditional binary outcomes, the use of ordinal outcomes in trials of cirrhosis decompensation may provide more power and thus may require a smaller sample size.
Topics: Alcoholism; Chi-Square Distribution; Clinical Trials as Topic; Disease Progression; Endpoint Determination; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Humans; Liver Cirrhosis; Outcome Assessment, Health Care; Platelet Count; Prognosis; Research Design; Risk Assessment; Virus Diseases
PubMed: 31837238
DOI: 10.1002/hep.31070 -
Anesthesia and Analgesia May 2020Use of the electronic health record (EHR) has become a routine part of perioperative care in the United States. Secondary use of EHR data includes research, quality, and... (Review)
Review
Considerations for Integration of Perioperative Electronic Health Records Across Institutions for Research and Quality Improvement: The Approach Taken by the Multicenter Perioperative Outcomes Group.
Use of the electronic health record (EHR) has become a routine part of perioperative care in the United States. Secondary use of EHR data includes research, quality, and educational initiatives. Fundamental to secondary use is a framework to ensure fidelity, transparency, and completeness of the source data. In developing this framework, competing priorities must be considered as to which data sources are used and how data are organized and incorporated into a useable format. In assembling perioperative data from diverse institutions across the United States and Europe, the Multicenter Perioperative Outcomes Group (MPOG) has developed methods to support such a framework. This special article outlines how MPOG has approached considerations of data structure, validation, and accessibility to support multicenter integration of perioperative EHRs. In this multicenter practice registry, MPOG has developed processes to extract data from the perioperative EHR; transform data into a standardized format; and validate, deidentify, and transfer data to a secure central Coordinating Center database. Participating institutions may obtain access to this central database, governed by quality and research committees, to inform clinical practice and contribute to the scientific and clinical communities. Through a rigorous and standardized approach to ensure data integrity, MPOG enables data to be usable for quality improvement and advancing scientific knowledge. As of March 2019, our collaboration of 46 hospitals has accrued 10.7 million anesthesia records with associated perioperative EHR data across heterogeneous vendors. Facilitated by MPOG, each site retains access to a local repository containing all site-specific perioperative data, distinct from source EHRs and readily available for local research, quality, and educational initiatives. Through committee approval processes, investigators at participating sites may additionally access multicenter data for similar initiatives. Emerging from this work are 4 considerations that our group has prioritized to improve data quality: (1) data should be available at the local level before Coordinating Center transfer; (2) data should be rigorously validated against standardized metrics before use; (3) data should be curated into computable phenotypes that are easily accessible; and (4) data should be collected for both research and quality improvement purposes because these complementary goals bolster the strength of each endeavor.
Topics: Biomedical Research; Electronic Health Records; Humans; Multicenter Studies as Topic; Outcome Assessment, Health Care; Perioperative Care; Quality Improvement
PubMed: 32287121
DOI: 10.1213/ANE.0000000000004489 -
Seminars in Oncology Oct 2020COVID-19 has a clear sex disparity in clinical outcome. Globally, infection rates between men and women are similar; however, men are more likely to have more severe... (Review)
Review
COVID-19 has a clear sex disparity in clinical outcome. Globally, infection rates between men and women are similar; however, men are more likely to have more severe disease and are more likely to die. The causes for this disparity are currently under investigation and are most likely multifactorial. Sex hormones play an important role in the immune response with estrogen seen as immune boosting and testosterone as immunosuppressing. Additionally, an important protease involved in viral entry, TMPRSS2, is regulated by androgens. Many observational and prospective studies are ongoing or initiating to further examine the role of sex hormones in SARS-CoV-2 infection and if modulation of them is a realistic treatment option.
Topics: Androgen Antagonists; COVID-19; Female; Gonadal Steroid Hormones; Humans; Male; Outcome Assessment, Health Care; Pandemics; Protease Inhibitors; Serine Endopeptidases; Sex Factors; COVID-19 Drug Treatment
PubMed: 32660890
DOI: 10.1053/j.seminoncol.2020.06.002 -
Clinical Infectious Diseases : An... Dec 2021
Topics: COVID-19; Healthcare Disparities; Humans; Outcome Assessment, Health Care; SARS-CoV-2
PubMed: 33111148
DOI: 10.1093/cid/ciaa1460 -
The American Journal on Addictions Jul 2020Medications for opioid use disorder (MOUD) reduce opioid use and overdose; however, MOUD clinical trials have used varying primary outcomes to document treatment... (Review)
Review
BACKGROUND AND OBJECTIVES
Medications for opioid use disorder (MOUD) reduce opioid use and overdose; however, MOUD clinical trials have used varying primary outcomes to document treatment success. We conducted a literature review to assess and critically examine the methodologies used in MOUD treatment studies.
METHODS
Published studies in English that examined MOUD (buprenorphine, methadone, or extended-release naltrexone) were included (N = 20). The methods and frequencies of measuring primary opioid outcomes, including urine drug tests (UDTs) and self-report of opioid use were compared among studies.
RESULTS
A total of 20 studies fit the inclusion criteria. Each study assessed opioid use; only 12 had opioid use as a primary outcome. Other primary outcomes included retention in treatment (N = 6), and two had other primary outcomes (death and opioid withdrawal symptoms). Opioid use was assessed through both self-report and UDTs in 15 studies. Two studies did not use UDTs. Differences were found in the methods used for how opioid use, retention in treatment, self-report of opioid use, and UDTs were measured.
DISCUSSION AND CONCLUSIONS
The different primary outcomes used and operational definitions in each study make comparisons between studies difficult. The use of both self-report and UDTs for opioid use has several advantages, and if possible, researchers should use both measures.
SCIENTIFIC SIGNIFICANCE
This is the first review critically examining outcome measures from MOUD treatment studies. Creating a standard for opioid treatment outcomes in MOUD studies will allow for generalizable results that can inform both researchers and clinicians to better care for those with OUD. (Am J Addict 2020;00:00-00).
Topics: Humans; Narcotic Antagonists; Opioid-Related Disorders; Outcome Assessment, Health Care; Treatment Outcome
PubMed: 32346932
DOI: 10.1111/ajad.13051 -
Arquivos Brasileiros de Oftalmologia 2021The purpose of this study is to translate and validate a Portuguese version of the Keratoconus Outcomes Research Questionnaire. The Keratoconus Outcomes Research...
PURPOSE
The purpose of this study is to translate and validate a Portuguese version of the Keratoconus Outcomes Research Questionnaire. The Keratoconus Outcomes Research Questionnaire is a psychometrically robust and valid instrument used to assess the impact of keratoconus on activity limitations and symptoms.
METHODS
We performed a translation, cross-cultural adaptation, and validation of the Portuguese version of the Keratoconus Outcomes Research Questionnaire. The initial translation of the English version to the Portuguese language was performed by two independent native speaker translators, followed by an interdisciplinary panel evaluation of the translated version. The Portuguese version was then back-translated into English by two independent native speakers, followed by evaluation and comparison with the original English version by the same interdisciplinary panel. For subsequent validation, the translated questionnaire was administered at two different times to a population of 30 subjects, and the results were compared in a concordance analysis.
RESULTS
The translation into Portuguese and back-translation were determined to be correct. Thirty participants were enrolled in the study (mean age, 29.23 ± 7.56 years). Nine questions (31%) had almost perfect agreement (questions 3, 4, 5, 8, 18, 22, 27, 28, and 29), 15 questions (51.7%) had substantial agreement (questions 1, 2, 6, 7, 9, 12, 14, 15, 16, 17, 20, 21, 23, 25, and 26), 4 questions (13.8%) had moderate agreement (questions 10, 11, 19, and 24) and 1 question (3.5%) had reasonable agreement (question 13). High-correlation coefficients were obtained when comparing results of the initial application and second application of this questionnaire to a sample of 30 individuals, which indicated excellent concordance with regard to results, repeatability, and reliability.
CONCLUSIONS
This translated and validated questionnaire can be applied to a larger population with the intent to assess quality of life in keratoconus patients in the overall Brazilian population as well as in distinct regions of the country.
Topics: Adult; Brazil; Cross-Cultural Comparison; Humans; Keratoconus; Language; Outcome Assessment, Health Care; Portugal; Quality of Life; Reproducibility of Results; Surveys and Questionnaires; Translations; Young Adult
PubMed: 34320101
DOI: 10.5935/0004-2749.20210067 -
BMJ Open Feb 2022Melasma is a pigmentation disorder of the skin. Characterised by brown to gray-brown patches on the face and neck, the condition predominantly affects women and has been...
INTRODUCTION
Melasma is a pigmentation disorder of the skin. Characterised by brown to gray-brown patches on the face and neck, the condition predominantly affects women and has been associated with pregnancy, hormonal variation and sun exposure. Melasma can be disfiguring and anxiety-provoking, and quality of life is often adversely impacted. Management includes sun protection, laser and energy device therapy, topical and oral skin-bleaching agents and chemical peels. While clinical trials of melasma exist, there is a lack of consistency in reported outcomes, which has been a barrier to the aggregation of data in systematic reviews and meta-analyses. This protocol describes a planned process for development of a minimum set of outcomes (ie, 'core outcome set') that should be measured in all clinical trials of melasma.
METHODS AND ANALYSIS
An exhaustive list of potential outcomes will be extracted from four sources: (1) systematic literature review of outcomes in clinical trials; (2) semistructured patient interviews; (3) brochures, pamphlets, clinical trial registries, and other published and unpublished sources and documentation; and (4) interviews with non-patient, non-physician stakeholders, including federal regulators, industry scientists and non-physician providers. An international two-round Delphi process will then be performed to identify the outcomes deemed most important to patients and physicians. Subsequently, a consensus meeting will be convened to review and process the results, and to vote on a final set of core outcomes.
ETHICS AND DISSEMINATION
Ethics approval was provided by the Northwestern University Institutional Review Board (protocol ID: STU00201637). This study is registered with both the Core Outcome Measures in Effectiveness Trials and Cochrane Skin-Core Outcome Set Initiative initiatives, and this protocol is in accordance with the guidelines for protocol development of both groups. All findings from the study described in this protocol will be disseminated to all stakeholders involved in the development process and will be submitted for publication in peer-reviewed journals.
PROSPERO REGISTRATION NUMBER
CRD42020214189.
Topics: Delphi Technique; Female; Humans; Melanosis; Outcome Assessment, Health Care; Pregnancy; Quality of Life; Research Design; Systematic Reviews as Topic; Treatment Outcome
PubMed: 35121595
DOI: 10.1136/bmjopen-2020-046953 -
BMJ Open Sep 2022To develop a core outcome set (COS) for physical activity interventions in primary schools.
OBJECTIVES
To develop a core outcome set (COS) for physical activity interventions in primary schools.
DESIGN
Modified-Delphi study.
SETTING
The UK and international.
PARTICIPANTS
104 participants from four stakeholder groups (educators, public health professionals, health researchers, parents); 16 children (aged 8-9 years) from 1 London primary school.
INTERVENTIONS
Physical activity interventions.
METHODS
Four-stage process: (1) outcomes extracted from relevant studies identified from an umbrella review and a focus group; (2) list of outcomes produced and domains established; (3) stakeholders completed a two-round Delphi survey by rating (Round 1) and re-rating (Round 2) each outcome on a nine-point Likert Scale from 'not important' to 'critical': a>70% participant threshold identified the outcomes rated 'critical' to measure, and outcomes important to children were identified through a workshop; and (4) a stakeholder meeting to achieve consensus of the outcomes to include in the COS.
RESULTS
In total, 74 studies were extracted from 53 reviews. A list of 50 outcomes was produced and three domains were established: 'physical activity and health' (16 outcomes), 'social and emotional health' (22 outcomes) and 'educational performance' (12 outcomes). 104 participants completed survey Round 1; 65 participants completed both rounds. In total, 13 outcomes met the threshold; children identified 8 outcomes. Fourteen outcomes achieved consensus to produce the COS: five outcomes for physical activity and health (diet (varied and balanced), energy, fitness, intensity of physical activity, sleep (number of hours)); seven outcomes for social and emotional health (anxiety, depression, enjoyment, happiness, self-esteem, stress, well-being); and two outcomes for educational performance (concentration, focus).
CONCLUSIONS
We have developed the first COS for physical activity interventions in primary schools in consultation with those interested in the development and application of an agreed standardised set of outcomes. Future studies including these outcomes will reduce heterogeneity across studies.
TRIAL REGISTRATION NUMBER
Core Outcome Measures in Effectiveness Trials Initiative registration number 1322; Results.
Topics: Child; Delphi Technique; Exercise; Humans; Outcome Assessment, Health Care; Research Design; Schools; Treatment Outcome
PubMed: 36180126
DOI: 10.1136/bmjopen-2022-061335 -
European Journal of Physical and... Feb 2021Existing randomized controlled trials (RCTs) of arm rehabilitation interventions after stroke use a wide range of outcome measures, limiting ability to pool data to...
BACKGROUND
Existing randomized controlled trials (RCTs) of arm rehabilitation interventions after stroke use a wide range of outcome measures, limiting ability to pool data to determine efficacy. Published recommendations also lack stroke survivor, carer and clinician involvement specifically about perceived relevance and importance of outcomes and measures.
AIM
To generate international consensus recommendations for selection of outcome measures for use in future stroke RCTs in arm rehabilitation, considering outcomes important to stroke survivors, carers and clinicians. The recommendations are the Standardizing Measurement in Arm Rehabilitation Trials (SMART) Toolbox.
DESIGN
Two-round international e-Delphi Survey and consensus meeting.
SETTING
Online and University.
POPULATION
Fifty-five researchers and clinicians with expertise in stroke upper limb rehabilitation from 18 countries (e-Delphi); N.=13 researchers and clinicians, N.=2 stroke survivors, N.=1 carer (consensus meeting).
METHODS
Using systematically identified outcome measures from published RCTs, we conducted a two-round international e-Delphi Survey with researchers and clinicians to identify the most important measures for inclusion in the toolbox. Measures that achieved ≥60% consensus were categorized using the International Classification of Functioning, Disability and Health Framework (ICF); psychometric properties were ascertained from literature and research resources. At a final consensus meeting, expert stakeholders selected measures for inclusion in the toolbox.
RESULTS
e-Delphi participants recommended 28/170 measures for discussion at the final consensus meeting. Expert stakeholders (N.=16) selected the Visual Analogue Scale for pain/0-10 Numeric Pain Rating Scale, dynamometry, Action Research Arm Test, Wolf Motor Function Test, Barthel Index, Motricity Index and Fugl-Meyer Assessment (upper limb section of each), Box and Block Test, Motor Activity Log 14, Nine Hole Peg Test, Functional Independence Measure, EQ-5D, Canadian Occupational Performance Measure and Modified Rankin Scale for inclusion in the toolbox.
CONCLUSIONS
The SMART Toolbox provides a refined selection of measures that capture outcomes considered important by stakeholders for each ICF domain.
CLINICAL REHABILITATION IMPACT
The toolbox will facilitate data aggregation for efficacy analyses thereby strengthening evidence to inform clinical practice. Clinicians can also use the toolbox to guide selection of measures ensuring a patient-centered focus.
Topics: Delphi Technique; Humans; International Cooperation; Outcome Assessment, Health Care; Stroke Rehabilitation; Upper Extremity
PubMed: 33215905
DOI: 10.23736/S1973-9087.20.06575-2