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Patient satisfaction in treatment of non-complex fractures and dislocations in general practice in the Netherlands: prospective cohort study protocol.

ABSTRACT: INTRODUCTION:Diagnosis and treatment of fractures and dislocations are mostly performed in hospital settings. However, equal care for patients with non--complex fractures or dislocations ('minor trauma care') may be provided in general practice. While substitution of care from secondary to primary care settings is stimulated by governments and insurers, it is unknown what the effects are on patient satisfaction level. Therefore, our primary objective is to determine the effect of minor trauma care delivered in a general practice as compared with a hospital on patient satisfaction. Secondary objectives are to assess the effects on treatment outcomes, cost-effectiveness and time consumption. METHODS AND ANALYSIS:In a prospective cohort study, we will include 200 patients aged 12 and over with an X-ray confirmed diagnosis of a non--complex fracture or dislocation out of whom 100 treated in a general practice and 100 in a secondary care hospital, both located in the Netherlands. All treatment procedures and follow-up will be done in accordance to the hospital's standards of trauma care. Study assessments will be performed pre-treatment, and 1, 6 and 12 weeks after treatment. Data collected include demographics, patient satisfaction and patient-reported outcomes including physical functioning, complications, pain scores and treatment-related costs. The primary outcome patient satisfaction measured at 12 weeks will be compared between the settings and additionally multivariable regression will be performed to assess potential confounding effects of unbalanced prognostic factors. Treatment outcomes and time consumption will be analysed following the same approach while cost-effectiveness will be assessed using an incremental cost-effectiveness ratio. Subsequently, results will be discussed using focus groups consisting of patients (n=15) and healthcare providers. ETHICS AND DISSEMINATION:The Medical Ethics Committee from the University Medical Center Groningen reviewed this study protocol and granted exemption from ethical approval (METc UMCG 2017/277). Study results will be presented at (inter)national conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03506958; Pre-results.

SUBMITTER: Verbeek T

PROVIDER: S-EPMC6398798 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Patient satisfaction in treatment of non-complex fractures and dislocations in general practice in the Netherlands: prospective cohort study protocol.

Verbeek Tjitte T Arentsen Hans H Breet Evert Jan EJ Kuipers Machiel M MM Lubbert Pieter H W PHW Burger Huibert H

BMJ open 20190219 2

<h4>Introduction</h4>Diagnosis and treatment of fractures and dislocations are mostly performed in hospital settings. However, equal care for patients with non--complex fractures or dislocations ('minor trauma care') may be provided in general practice. While substitution of care from secondary to primary care settings is stimulated by governments and insurers, it is unknown what the effects are on patient satisfaction level. Therefore, our primary objective is to determine the effect of minor t ...[more]

PMID: 30782924

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Project description:IntroductionGout is the most common inflammatory arthritis in the Dutch general practice population and is often managed with long-term uric acid lowering treatment. The clinical relevance of this treatment in preventing gout attacks is unclear.Primary research questionWhat is the frequency of self-reported gout attacks and what is the effect of allopurinol use in patients diagnosed with gout in general practice?Methods and analysisAdult patients with a diagnostic consultation code for gout in the year 2013, 2014 or 2015 will be invited to participate in this prospective observational cohort study. Patients with a limited life expectancy will be excluded. Baseline measurements will include blood pressure, body mass index and a blood sample (estimated glomerular filtration rate, serum uric acid, cholesterol (low-density lipoprotein (LDL) and high-density lipoprotein), glucose (fasting)). At the 2-year follow-up, patients will receive questionnaires every 3 months. The questionnaires at baseline, 12 months and 24 months assess the frequency of gout attacks, the presence of tophi, comorbidity, medication use, quality of life, diet and lifestyle. The questionnaires in between only assess the frequency of gout attacks and medication use for gout. Descriptive statistics will be used to calculate the mean frequency of self-reported gout attacks during the 2-year follow-up. The propensity score for each patient being offered allopurinol is estimated and used to match patients with and without allopurinol treatment. We will compare the frequency of gout attacks in these groups using multilevel Poisson regression analyses. With this type of analysis, we can calculate the corrected estimated effect of allopurinol on gout attack frequency.Ethics and disseminationThe research protocol was approved by the Medical Ethical Committee of the Erasmus Medical Centre in Rotterdam. The knowledge generated by this study will be transferred to the Dutch College of General Practitioners, conferences and to (inter)national peer-reviewed journals.Trial registration numberNTR6329; Pre-results.

Project description:BackgroundKnowing where and why harm occurs in general practice will assist patients, doctors, and others in making informed decisions about the risks and benefits of treatment options. Research to date has been unable to verify the safety of primary health care and epidemiological research about patient harms in general practice is now a top priority for advancing health systems safety.ObjectiveWe aim to study the incidence, distribution, severity, and preventability of the harms patients experience due to their health care, from the whole-of-health-system lens afforded by electronic general practice patient records.Methods"Harm" is defined as disease, injury, disability, suffering, and death, arising from the health system. The study design is a stratified, 2-level cluster, retrospective records review study. Both general practices and patients will be randomly selected so that the study's results will apply nationally, after weighting. Stratification by practice size and rurality will allow comparisons between 6 study groups (large, medium-sized, small; urban and rural practices). Records of equal numbers of patients from each study group will be included in the study because there may be systematic differences in patient harms in different types of practices. Eight general practitioner investigators will review 3 years of electronic general practice health records (consultation notes, prescriptions, investigations, referrals, and summaries of hospital care) from 9000 patients registered in 60 general practices. Double-blinded reviews will check the concordance of reviewers' assessments. Study data will comprise demographic data of all 9000 patients and reviewers' assessments of whether patients experienced harm arising from health care. Where patient harm is identified, their types, preventability, severity, and outcomes will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) 18.0.ResultsWe have recruited practices and collected electronic records from 9078 patients. Reviews of these records are under way. The study is expected to be completed in August 2017.ConclusionsThe design of this complex study is presented with discussion on data collection methods, sampling weights, power analysis, and statistical approach. This study will show the epidemiology of patient harms recorded in general practice records for all of New Zealand and will show whether this epidemiology differs by rural location and clinic size.

Project description:IntroductionVertigo is a prevalent and burdensome symptom. More than 80% of patients with vertigo are primarily treated by their general practitioner (GP) and are never referred to a medical specialist. Despite this therapeutic responsibility, the GP's diagnostic toolkit has serious limitations. All recommended tests lack empirical evidence, because a diagnostic accuracy study on vestibular disorders ('How well does test x discriminate between patients with or without target condition y?') has never been performed in general practice. The VERtigo DIagnosis study aims to fill this gap.Methods and analysisWe will perform a diagnostic accuracy study on vertigo of primary vestibular origin in general practice to assess the discriminative ability of history taking and physical examination. We will compare all index tests with a respective reference standard. We will focus on five target conditions that account for more than 95% of vertigo diagnoses in general practice: (1) benign paroxysmal positional vertigo, (2) vestibular neuritis, (3) Ménière's disease, (4) vestibular migraine (VM) and (5) central causes other than VM. As these five target conditions have a different pathophysiology and lack one generally accepted gold standard, we will use consensus diagnosis as a construct reference standard. Data for each patient, including history, physical examination and additional tests as recommended by experts in an international Delphi procedure, will be recorded on a standardised form and independently reviewed by a neurologist and otorhinolaryngologist. For each patient, the reviewers have to decide about the presence/absence of each target condition. We will calculate sensitivity, specificity, predictive values, likelihood ratios and diagnostic ORs, followed by decision rules for each target condition.Ethics and disseminationThe study obtained approval from the Vrije Universiteit Medical Center Medical Ethical Review Committee (reference: 2022.0817-NL83111.029.22). We will publish our findings in peer-reviewed international journals.Trial registration numberISRCTN97250704.

Dataset Information

Patient satisfaction in treatment of non-complex fractures and dislocations in general practice in the Netherlands: prospective cohort study protocol.

Publications

Patient satisfaction in treatment of non-complex fractures and dislocations in general practice in the Netherlands: prospective cohort study protocol.

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