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

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

Two siblings with lichen planus and squamous cell carcinoma of the oesophagus

Lichen planus is a mucocutaneous disease which can also affect the oesophagus. Unlike in oral lichen planus an increased risk for the development of squamous cell carcinoma in the oesophagus has not been established. We describe two sisters with a history of long-standing cutaneous lichen planus who developed oesophageal squamous cell carcinoma, diagnosed at the ages of 68 and 70 years, respectively. In one of the cases, dysplastic areas were identified by high-magnification chromoendoscopy. In both cases, oesophageal resection was carried out with a curative intent. For the first time these sibling case reports suggest an increased precancerous potential of oesophageal lichen planu

The value of nonoperative versus operative treatment of frail institutionalized elderly patients with a proximal femoral fracture in the shade of life (FRAIL-HIP); protocol for a multicenter observational cohort study

Background: Proximal femoral fractures are strongly associated with morbidity and mortality in elderly patients. Mortality is highest among frail institutionalized elderly with both physical and cognitive comorbidities who consequently have a limited life expectancy. Evidence based guidelines on whether or not to operate on these patients in the case of a proximal femoral fracture are lacking. Practice variation occurs, and it remains unknown if nonoperative treatment would result in at least the same quality of life as operative treatment. This study aims to determine the effect of nonoperative management versus operative management of proximal femoral fractures in a selected group of frail institutionalized elderly on the quality of life, level of pain, rate of complications, time to death, satisfaction of the patient (or proxy) and the caregiver with the management strategy, and health care consumption. Methods: This is a multicenter, observational cohort study. Frail institutionalized elderly (70 years or older with a body mass index < 18.5, a Functional Ambulation Category of 2 or lower pre-trauma, or an American Society of Anesthesiologists score of 4 or 5), who sustained a proximal femoral fracture are eligible to participate. Patients with a pathological or periprosthetic fractures and known metastatic oncological disease will be excluded. Treatment decision will be reached following a structured shared decision process. The primary outcome is quality of life (Euro-QoL; EQ-5D-5 L). Secondary outcome measures are quality of life measured with the QUALIDEM, pain level (PACSLAC), pain medication use, treatment satisfaction of patient (or proxy) and caregivers, quality of dying (QODD), time to death, and direct medical costs. A cost-utility and cost-effectiveness analysis will be done, using the EQ-5D utility score and QUALIDEM score, respectively. Non-inferiority of nonoperative treatment is assumed with a limit of 0.15 on the EQ-5D score. Data will be acquired at 7, 14, and 30 days and at 3 and 6 months after trauma. Discussion: The results of this study will provide insight into the true value of nonoperative treatment of proximal femoral fractures in frail elderly with a limited life expectancy. The results may be used for updating (inter)national treatment guidelines. Trial registration: The study is registered at the Netherlands Trial Register (NTR7245; date 10-06-2018)