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1.  Diagnostic and treatment delay, quality of life and satisfaction with care in colorectal cancer patients: a study protocol 
Background
Due to recent improvements in colorectal cancer survival, patient-reported outcomes, including health-related quality of life and satisfaction with care, have become well-established endpoints to determine the impact of the disease on the lives of patients.
The aim of this study is to determine prospectively, in a cohort of colorectal cancer incident cases: a) health-related quality of life, b) satisfaction with hospital-based care, and c) functional status. A secondary objective is to determine whether diagnostic/therapeutic delay influence quality of life or patients’ satisfaction levels.
Methods/design
Single-centre prospective follow-up study of colorectal cancer patients diagnosed during the period 2011–2012 (n = 375).
This project was approved by the corresponding ethics review board, and informed consent is obtained from each patient. After diagnosis, patients are interviewed by a trained nurse, obtaining information on sociodemographic characteristics, family history of cancer, first symptoms, symptom perception and reaction to early symptoms. Quality of life is assessed with the EORTC QLQ-C30 and QLQ-CR29 questionnaires, and patients’ satisfaction with care is determined using the EORTC IN-PATSAT32. Functional status is measured with the Karnofsky Performance Status Scale.
Clinical records are also reviewed to collect information on comorbidity, tumour characteristics, treatment, hospital consultations and exploratory procedures.
Symptoms-to-diagnosis interval is defined as the time from the date of first symptoms until the cytohistological confirmation of cancer. Treatment delay is defined as the time between diagnosis and surgical treatment.
All the patients will be followed-up for a maximum of 2 years. For survivors, assessments will be re-evaluated at one and two years after the diagnosis.
Multiple linear/logistic regression models will be used to identify variables associated with the patients’ functional status, quality of life and satisfaction with care score. Changes in quality of life over time will be analysed with linear mixed-effects regression models.
Discussion
The results will provide a deeper understanding of the impact of colorectal cancer from a more patient-centred approach, allowing us to identify groups of patients in need of additional attention, as well as areas for improvement. Special attention will be given to the relationship between diagnostic/therapeutic delay and patients’ quality of life and satisfaction with the care received.
doi:10.1186/1477-7525-11-117
PMCID: PMC3710493  PMID: 23845102
Colorectal neoplasms; Quality of life; Patient satisfaction
2.  Factors related with symptom duration until diagnosis and treatment of symptomatic colorectal cancer 
BMC Cancer  2013;13:87.
Background
Colorectal cancer (CRC) survival depends mostly on stage at the time of diagnosis. However, symptom duration at diagnosis or treatment have also been considered as predictors of stage and survival. This study was designed to: 1) establish the distinct time-symptom duration intervals; 2) identify factors associated with symptom duration until diagnosis and treatment.
Methods
This is a cross-sectional study of all incident cases of symptomatic CRC during 2006–2009 (795 incident cases) in 5 Spanish regions. Data were obtained from patients’ interviews and reviews of primary care and hospital clinical records. Measurements: CRC symptoms, symptom perception, trust in the general practitioner (GP), primary care and hospital examinations/visits before diagnosis, type of referral and tumor characteristics at diagnosis. Symptom Diagnosis Interval (SDI) was calculated as time from first CRC symptoms to date of diagnosis. Symptom Treatment Interval (STI) was defined as time from first CRC symptoms until start of treatment. Nonparametric tests were used to compare SDI and STI according to different variables.
Results
Symptom to diagnosis interval for CRC was 128 days and symptom treatment interval was 155. No statistically significant differences were observed between colon and rectum cancers. Women experienced longer intervals than men. Symptom presentation such as vomiting or abdominal pain and the presence of obstruction led to shorter diagnostic or treatment intervals. Time elapsed was also shorter in those patients that perceived their first symptom/s as serious, disclosed it to their acquaintances, contacted emergencies services or had trust in their GPs. Primary care and hospital doctor examinations and investigations appeared to be related to time elapsed to diagnosis or treatment.
Conclusions
Results show that gender, symptom perception and help-seeking behaviour are the main patient factors related to interval duration. Health service performance also has a very important role in symptom to diagnosis and treatment interval. If time to diagnosis is to be reduced, interventions and guidelines must be developed to ensure appropriate examination and diagnosis during both primary and hospital care.
doi:10.1186/1471-2407-13-87
PMCID: PMC3598975  PMID: 23432789
Colorectal cancer; Early diagnosis; Primary health care; Delay
3.  Electrocardiographic abnormalities in centenarians: impact on survival 
BMC Geriatrics  2012;12:15.
Background
The centenarian population is gradually increasing, so it is becoming more common to see centenarians in clinical practice. Electrocardiogram abnormalities in the elderly have been reported, but several methodological biases have been detected that limit the validity of their results. The aim of this study is to analyse the ECG abnormalities in a prospective study of the centenarian population and to assess their impact on survival.
Method
We performed a domiciliary visit, where a medical history, an ECG and blood analysis were obtained. Barthel index (BI), cognitive mini-exam (CME) and Charlson index (ChI) were all determined. Patients were followed up by telephone up until their death.
Results
A total of 80 centenarians were studied, 26 men and 64 women, mean age 100.8 (SD 1.3). Of these, 81% had been admitted to the hospital at least once in the past, 81.3% were taking drugs (mean 3.3, rank 0–11). ChI was 1.21 (SD 1.19). Men had higher scores both for BI (70 -SD 34.4- vs. 50.4 -SD 36.6-, P = .005) and CME (16.5 -SD 9.1- vs. 9.1 –SD 11.6-, P = .008); 40.3% of the centenarians had anaemia, 67.5% renal failure, 13% hyperglycaemia, 22.1% hypoalbuminaemia and 10.7% dyslipidaemia, without statistically significant differences regarding sex. Only 7% had a normal ECG; 21 (26.3%) had atrial fibrillation (AF), 30 (37.5%) conduction defects and 31 (38.8%) abnormalities suggestive of ischemia, without sex-related differences. A history of heart disease was significantly associated with the presence of AF (P = .002, OR 5.2, CI 95% 1.8 to 15.2) and changes suggestive of ischemia (P = .019, OR 3.2, CI 95% 1.2-8.7). Mean survival was 628 days (SD 578.5), median 481 days. Mortality risk was independently associated with the presence of AF (RR 2.0, P = .011), hyperglycaemia (RR 2.2, P = .032), hypoalbuminaemia (RR 3.5, P < .001) and functional dependence assessed by BI (RR 1.8, P = .024).
Conclusion
Although ECG abnormalities are common in centenarians, they are not related to sex, functional capacity or cognitive impairment. The only abnormality that has an impact on survival is AF.
doi:10.1186/1471-2318-12-15
PMCID: PMC3416736  PMID: 22520618
4.  Suicide attempts and related factors in patients admitted to a general hospital: a ten-year cross-sectional study (1997-2007) 
BMC Psychiatry  2011;11:51.
Background
Suicide and suicide attempts represent a severe problem for public health services. The aim of this study is to determine the socio-demographic and psychopathological variables associated with suicide attempts in the population admitted to a General Hospital.
Methods
An observational-descriptive study of patients admitted to the A Coruña University Hospital (Spain) during the period 1997-2007, assessed by the Consultation and Liaison Psychiatric Unit. We include n = 5,234 admissions from 4,509 patients. Among these admissions, n = 361 (6.9%) were subsequent to a suicide attempt. Admissions arising from a suicide attempt were compared with admissions occurring due to other reasons.
Multivariate generalised estimating equation logistic regression models were used to examine factors associated with suicide attempts.
Results
Adjusting by age, gender, educational level, cohabitation status, being employed or unemployed, the psychiatric diagnosis at the time of the interview and the information on previous suicide attempts, we found that the variables associated with the risk of a suicide attempt were: age, psychiatric diagnosis and previous suicide attempts.
The risk of suicide attempts decreases with age (OR = 0.969). Psychiatric diagnosis was associated with a higher risk of suicide attempts, with the highest risk being found for Mood or Affective Disorders (OR = 7.49), followed by Personality Disorders (OR = 7.31), and Schizophrenia and Other Psychotic Disorders (OR = 5.03).
The strongest single predictive factor for suicide attempts was a prior history of attempts (OR = 23.63).
Conclusions
Age, psychopathological diagnosis and previous suicide attempts are determinants of suicide attempts.
doi:10.1186/1471-244X-11-51
PMCID: PMC3078091  PMID: 21453478
5.  Incidence of cardiovascular events after kidney transplantation and cardiovascular risk scores: study protocol 
Background
Cardiovascular disease (CVD) is the major cause of death after renal transplantation. Not only conventional CVD risk factors, but also transplant-specific risk factors can influence the development of CVD in kidney transplant recipients.
The main objective of this study will be to determine the incidence of post-transplant CVD after renal transplantation and related factors. A secondary objective will be to examine the ability of standard cardiovascular risk scores (Framingham, Regicor, SCORE, and DORICA) to predict post-transplantation cardiovascular events in renal transplant recipients, and to develop a new score for predicting the risk of CVD after kidney transplantation.
Methods/Design
Observational prospective cohort study of all kidney transplant recipients in the A Coruña Hospital (Spain) in the period 1981-2008 (2059 transplants corresponding to 1794 patients).
The variables included will be: donor and recipient characteristics, chronic kidney disease-related risk factors, pre-transplant and post-transplant cardiovascular risk factors, routine biochemistry, and immunosuppressive, antihypertensive and lipid-lowering treatment. The events studied in the follow-up will be: patient and graft survival, acute rejection episodes and cardiovascular events (myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances and peripheral vascular disease).
Four cardiovascular risk scores were calculated at the time of transplantation: the Framingham score, the European Systematic Coronary Risk Evaluation (SCORE) equation, and the REGICOR (Registre Gironí del COR (Gerona Heart Registry)), and DORICA (Dyslipidemia, Obesity, and Cardiovascular Risk) functions.
The cumulative incidence of cardiovascular events will be analyzed by competing risk survival methods. The clinical relevance of different variables will be calculated using the ARR (Absolute Risk Reduction), RRR (Relative Risk Reduction) and NNT (Number Needed to Treat).
The ability of different cardiovascular risk scores to predict cardiovascular events will be analyzed by using the c index and the area under ROC curves. Based on the competing risks analysis, a nomogram to predict the probability of cardiovascular events after kidney transplantation will be developed.
Discussion
This study will make it possible to determine the post-transplant incidence of cardiovascular events in a large cohort of renal transplant recipients in Spain, to confirm the relationship between traditional and transplant-specific cardiovascular risk factors and CVD, and to develop a score to predict the risk of CVD in these patients.
doi:10.1186/1471-2261-11-2
PMCID: PMC3022886  PMID: 21639867
6.  Diagnosis delay and follow-up strategies in colorectal cancer. Prognosis implications: a study protocol 
BMC Cancer  2010;10:528.
Background
Controversy exists with regard to the impact that the different components of diagnosis delay may have on the degree of invasion and prognosis in patients with colorectal cancer. The follow-up strategies after treatment also vary considerably. The aims of this study are: a) to determine if the symptoms-to-diagnosis interval and the treatment delay modify the survival of patients with colorectal cancer, and b) to determine if different follow-up strategies are associated with a higher survival rate.
Methods/Design
Multi-centre study with prospective follow-up in five regions in Spain (Galicia, Balearic Islands, Catalonia, Aragón and Valencia) during the period 2010-2012. Incident cases are included with anatomopathological confirmation of colorectal cancer (International Classification of Diseases 9th revision codes 153-154) that formed a part of a previous study (n = 953).
At the time of diagnosis, each patient was given a structured interview. Their clinical records will be reviewed during the follow-up period in order to obtain information on the explorations and tests carried out after treatment, and the progress of these patients.
Symptoms-to-diagnosis interval is defined as the time calculated from the diagnosis of cancer and the first symptoms attributed to cancer. Treatment delay is defined as the time elapsed between diagnosis and treatment. In non-metastatic patients treated with curative intention, information will be obtained during the follow-up period on consultations performed in the digestive, surgery and oncology departments, as well as the endoscopies, tumour markers and imaging procedures carried out.
Local recurrence, development of metastases in the follow-up, appearance of a new tumour and mortality will be included as outcome variables.
Actuarial survival analysis with Kaplan-Meier curves, Cox regression and competitive risk survival analysis will be performed.
Discussion
This study will make it possible to verify if the different components of delay have an impact on survival rate in colon cancer and rectal cancer. In consequence, this multi-centre study will be able to detect the variability present in the follow-up of patients with colorectal cancer, and if this variability modifies the prognosis. Ideally, this study could determine which follow-up strategies are associated with a better prognosis in colorectal cancer.
doi:10.1186/1471-2407-10-528
PMCID: PMC2958943  PMID: 20920369
7.  Respiratory physiotherapy and incidence of pulmonary complications in off-pump coronary artery bypass graft surgery: an observational follow-up study 
Background
Heart surgery is associated with an occurrence of pulmonary complications. The aim of this study was to determine whether pre-surgery respiratory physiotherapy reduces the incidence of post-surgery pulmonary complications.
Methods
Observational study of 263 patients submitted to off-pump coronary artery bypass grafting (CABG) surgery at the A Coruña University Hospital (Spain). 159 (60.5%) patients received preoperative physiotherapy. The fact that patients received preoperative physiotherapy or not was related to whether they were admitted to the cardiac surgery unit or to an alternative unit due to a lack of beds.
A physiotherapist provided a daily session involving incentive spirometry, deep breathing exercises, coughing and early ambulation. A logistic regression analysis was carried out in order to identify variables associated with pulmonary complications.
Results
Both groups of patients (those that received physiotherapy and those that did not) were similar in age, sex, body mass index, creatinine, ejection fraction, number of affected vessels, O2 basal saturation, prevalence of diabetes, dyslipidemia, exposure to tobacco, age at smoking initiation, number of cigarettes/day and number of years as a smoker. The most frequent postoperative complications were hypoventilation (90.7%), pleural effusion (47.5%) and atelectasis (24.7%).
In the univariate analysis, prophylactic physiotherapy was associated with a lower incidence of atelectasis (17% compared to 36%, p = 0.01).
After taking into account age, sex, ejection fraction and whether the patients received physiotherapy or not, we observed that receiving physiotherapy is the variable with an independent effect on predicting atelectasis.
Conclusion
Preoperative respiratory physiotherapy is related to a lower incidence of atelectasis.
doi:10.1186/1471-2466-9-36
PMCID: PMC2727489  PMID: 19638209

Results 1-7 (7)