Post-implementation surveillance of a non-pharmacological health technology within a national health service.

OBJECTIVES: The aim of this study was to describe 8-year results from post-implementation surveillance of neuroreflexotherapy (NRT), a health technology proven effective for treating neck and back pain. METHODS: Post-implementation surveillance included all patients undergoing NRT across five regions within the Spanish National Health Service (SNHS). Validated methods were used to assess pain, disability, adverse events, use of health resources, and patient satisfaction. Logistic regression models were developed to identify the variables associated with the risk of a pain episode requiring more than one NRT intervention. The number of relapses among discharged patients during the 8-year period was calculated. RESULTS: Between January 1, 2004, and June 30, 2012, 9,023 patients (median age: 53 years), presenting 11,384 subacute (25.2 percent) and chronic (74.8 percent), neck or back pain episodes, were discharged after receiving NRT. Spinal pain improved in 89 percent of cases, 83 percent abandoned drugs, and 0.02 percent required spine surgery. The only adverse event was skin discomfort (8.0 percent of patients). Number of patient complaints was 0, and answers to a standardized questionnaire reflected a high degree of satisfaction (response rate: 76.7 percent). Of the pain episodes, 18.9 percent required more than one NRT intervention; logistic regression models identified the variables associated with this. Over the 8-year period, the proportion of discharged patients referred for treatment due to relapse at the same level for neck, thoracic, and low back pain, was 16.4 percent, 6.5 percent, and 14.5 percent respectively. CONCLUSIONS: Post-marketing surveillance for a non-pharmacological technology is feasible within the SNHS. These results support generalizing NRT across the entire SNHS under the current validated application conditions.

Predicting outcomes of neuroreflexotherapy in patients with subacute or chronic neck or low back pain.

BACKGROUND CONTEXT: In the context of shared decision-making, a valid estimation of the probability that a given patient will improve after a specific treatment is valuable. PURPOSE: To develop models that predict the improvement of spinal pain, referred pain, and disability in patients with subacute or chronic neck or low back pain undergoing a conservative treatment. STUDY DESIGN AND SETTING: Analysis of data from a prospective registry in routine practice. PATIENT SAMPLE: All patients who had been discharged after receiving a conservative treatment within the Spanish National Health Service (SNHS) (n=8,778). OUTCOME MEASURES: Spinal pain, referred pain, and disability were assessed before the conservative treatment and at discharge by the use of previously validated methods. METHODS: Improvement in spinal pain, referred pain, and disability was defined as a reduction in score greater than the minimal clinically important change. A predictive model that included demographic, clinical, and work-related variables was developed for each outcome using multivariate logistic regression. Missing data were addressed using multiple imputation. Discrimination and calibration were assessed for each model. The models were validated by bootstrap, and nomograms were developed. RESULTS: The following variables showed a predictive value in the three models: baseline scores for pain and disability, pain duration, having undergone X-ray, having undergone spine surgery, and receiving financial assistance for neck or low back pain. Discrimination of the three models ranged from slight to moderate, and calibration was good. CONCLUSIONS: A registry in routine practice can be used to develop models that estimate the probability of improvement for each individual patient undergoing a specific form of treatment. Generalizing this approach to other treatments can be valuable for shared decision making.

Country of origin and prevention of breast cancer: beliefs, knowledge and barriers.

This study describes the concept of prevention and identifies the knowledge, perceived benefits and barriers, as well as the practices of early detection of breast cancer among women from different cultural backgrounds and socioeconomic levels. A socioconstructivist qualitative study was conducted in Barcelona. The study population consisted of women who were either native (Spanish) or immigrants from low income countries, aged 40 to 69 years. Narrations of the 68 informants were subjected to sociological discourse analysis. Place and culture of origin, social class and the migratory process can either facilitate or constitute barriers to breast cancer prevention.

The psychological impact of a false-positive screening mammogram in Barcelona.

The purpose of this study was to ascertain the psychological impact of mammographic screening for women who receive negative results and for those who need additional non-invasive and invasive complementary investigations to exclude breast cancer (false positives). One hundred fifty women who attended a breast cancer screening programme in Barcelona, aged 50-69 years, were included in this study: 50 with negative results and 100 with false positive mammograms (50 underwent non-invasive and 50 underwent invasive complementary investigations). Participants worried little until they underwent mammography, but worries increased when a telephone call notified the women of the need for further testing. A substantial proportion of women requiring further assessment reported that they were at least somewhat worried about having breast cancer throughout the screening process (P < 0.0001). Nevertheless, levels of anxiety and depression, measured by the Hospital Anxiety and Depression Scale, showed no statistically significant differences among the three groups. In conclusion, although the women showed no psychological morbidity, there is a substantial psychological response in those with an abnormal screening mammogram.

Knowledge, attitude and perceptions of breast cancer screening among native and immigrant women in Barcelona, Spain.

OBJECTIVE: Inequalities between immigrant and native populations in terms of access and use of health services have been described. The objective is to compare knowledge, attitudes, vulnerabilities, benefits and barriers related to breast cancer (BC) and screening mammography among women from different countries resident in Barcelona. METHODS: A cross-sectional survey carried out in Barcelona in 2009. The study population consisted of female residents in Barcelona between 45 and 69 years of age; participants were Spanish nationals or immigrants from low-income countries. 960 participants were asked 72 questions, mainly with Likert responses. The dependent variables were five quantitative scales: (1) knowledge of BC and early detection, (2) attitude towards health and BC, (3) vulnerability to BC, (4) barriers to mammography, (5) benefits of mammography. The independent variables were country of origin, social class, setting, cohabitation, age, mammography use, length of residence and fluency of the language. Analyses compared scale scores stratified by the independent variables. Multivariable linear regression models were fitted to determine the relationship between the scales and the independent variables. RESULTS: We observed inequalities according to country of origin on all scales after adjustment for independent variables. Chinese women presented the greatest differences with respect to native women, followed by Maghrebi and Filipino women. Inequalities exist on the vulnerability and barriers scales according to social class and urban/rural setting, and on the attitude scale according to social class. CONCLUSIONS: Country of origin, social class and urban/rural setting are key contributors to inequality in these scales.

Implementation of digital mammography in a population-based breast cancer screening program: effect of screening round on recall rate and cancer detection.

PURPOSE: To compare the effect of the introduction of digital mammography on the recall rate, detection rate, false-positive rate, and rates of invasive procedures performed in the first and successive rounds of a population-based breast cancer screening program with double reading in Barcelona, Spain. MATERIALS AND METHODS: The study was approved by the ethics committee; informed consent was not required. Data were compared from 12,958 women aged 50-69 years old who participated in a screening round before the introduction of digital mammography (screen-film mammography group) with data from 6074 women who participated in another screening round after the introduction of digital mammography (digital mammography group). Groups were compared for recall rate and detection rate stratified according to first or successive screening rounds, and logistic regression analysis was performed. RESULTS: Overall recall rates for screen-film and digital mammography groups were 5.5% and 4.2%, respectively (P < .001). The recall rate was higher in the first screening round (11.5% and 11.1% in the screen-film mammography and digital mammography groups, respectively; P = .68) than in successive screening rounds (3.6% and 2.4% in the screen-film mammography and digital mammography groups, respectively; P < .001). The main factors related to the risk of recall were screen-film mammography group (odds ratio = 1.28), first screening round (odds ratio = 3.53), menopausal status (odds ratio = 0.62), and history of personal benign breast disease (odds ratio = 2.26). No significant differences were found in the cancer detection rate between groups. In the first screening round, this rate was higher in the digital than in the screen-film mammography group (1.1% and 0.4%, respectively; P = .009). The invasive test rate was 2.6% and 1.3% in the screen-film and digital mammography groups, respectively (P < .001) and was lower with digital mammography than with screen-film mammography in both the first and successive screening rounds. CONCLUSION: Digital mammography may reduce the adverse effects of screening programs if this technique is confirmed to have the same diagnostic accuracy as screen-film mammography.

Results of a cervical cancer screening programme from an area of Barcelona (Spain) with a large immigrant population.

BACKGROUND: To assess the participation rate and results of cytological assessment in the context of cervical cancer screening activities in an area of Barcelona (Spain) with a large immigrant population. METHODS: Descriptive retrospective study of cytologies performed between 2001 and 2006 in women > or =14 years of age living in 2 out of 10 districts of Barcelona (n = 129 327) and participating in cervical cancer screening activities within a sexual and reproductive health care programme. RESULTS: Between 2001 and 2006, overall participation among women aged 20- to 64-years old was 50.7%, with higher participation among women aged 20-34 years than among those aged 50-64 years (63.8 and 36.0%, respectively; P < 0.01). The median frequency was 0.5 cytologies/year. The rate of pathological results increased from 11.4 per thousand in 2001 to 29.0 per thousand in 2006 (P < 0.001). This increase was higher among younger women and was mainly due to an increase in the rate of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (L-SIL). CONCLUSIONS: These results show a low rate of participation in the public cervical cancer screening programme and an increase in the number of pathological results during the study period. These results provide useful information at a time when significant changes in the prevention of cervical cancer are being planned.

Trends in hormone therapy use before and after publication of the Women's Health Initiative trial: 10 years of follow-up.

OBJECTIVE: The aim of this study was to assess the impact of the scientific evidence reported by Women's Health Initiative (WHI) trial on hormone therapy (HT) use in a 10-year follow-up retrospective cohort of women participating in a breast cancer screening program. METHODS: Between 1998 and 2007, a retrospective cohort of participants in a population-based breast cancer screening program in the city of Barcelona (Catalonia, Spain) was assessed. The study population consisted of 50,918 women. Trends in current HT use and the annual rate of new users were analyzed by age group. RESULTS: From 1998, successive annual increases were found in the prevalence levels of HT use in all age groups. In 2002, the prevalence peaked at 11% in 50- to 54-year-olds and at 10.1% in 55- to 59-year-olds, followed by a sudden reversal and a progressive decrease. In 2007, 5 years after the publication of the WHI trial, the HT use decreased by 89.1% in 50- to 54-year-olds, 87.5% in 55- to 59-year-olds, 84.6% in 60- to 64-year-olds, and 66.0% in 65- to 69-year-olds. The percentage of new users also fell substantially after 2002. CONCLUSIONS: HT use decreased during the 5 years after the publication of the WHI. This reduction was especially marked in the first 2 years, when the decrease in new treatments exceeded the number of continuations. In the following 3 years, the decrease was approximately equal in both groups.

[Results of a study on populational colorectal cancer screening]. / Resultados de un estudio de cribado poblacional de neoplasia colorrectal.

INTRODUCTION: As colorectal cancer (CRC) screening based on occult blood detection has been shown to be effective in reducing mortality due to this disease, it is now important to decide on the best methods to obtain the maximum numbers of participants. The aim of the study was to analyse the results from a pilot CRC screening programme in a general population sample in Barcelona. A follow-up of false positive cases was made after five years. PATIENTS AND METHOD: A cross section of the population aged 50-74 years in one primary health care centre was studied. The screening test consisted of an immunological method for the detection of faecal occult blood which was sent to the homes of the target population. RESULTS: Participation was 46.6%, 11.7% of the tests were positive, and 79.3% agreed to have a colonoscopy. Eight adenocarcinomas and 32 patients with adenomas >0.4 cm were diagnosed. CONCLUSIONS: The results obtained on the initial participation and the follow-up at five years suggest the viability of a CCR screening programme in our country.

Resultados de un estudio de cribado poblacional de neoplasia colorrectal / Results of a study on populational colorectal cancer screening

Introducción: el cribado poblacional de cáncer colorrectal (CCR) basado en la detección de sangre oculta en heces se ha demostrado efectivo en disminuir la mortalidad por esta enfermedad, si bien es importante encontrar los métodos adecuados para obtener una participación suficiente. El objetivo del estudio fue analizar los resultados clínicos de un programa piloto de cribado de CCR y las causas de rechazo. También se realizó el seguimiento de los casos falsos positivos a los 5 años. Pacientes y método: se diseñó un estudio de corte transversal en una población diana de 2.105 personas de 50 a 74 años atendidas en un centro de asistencia primaria. La prueba de cribado fue un método inmunológico, que se remitió al domicilio de la población diana. Resultados: la participación fue del 46,6%, el porcentaje de positividad de la prueba fue del 11,7% y la aceptación de la colonoscopia fue del 79,3%. Se diagnosticó en total a 32 pacientes con adenomas >0,4cm y a 8 con CCR. Conclusiones: los resultados obtenidos en nuestro estudio, tanto en participación como el seguimiento a los 5 años, permiten creer en la factibilidad de un programa de cribado poblacional de la neoplasia colorrectal en nuestro país (AU)

Introduction: As colorectal cancer (CRC) screening based on occult blood detection has been shown to be effective in reducing mortality due to this disease, it is now important to decide on the best methods to obtain the maximum numbers of participants. The aim of the study was to analyse the results from a pilot CRC screening programme in a general population sample in Barcelona. A follow-up of false positive cases was made after five years. Patients and method: A cross section of the population aged 50–74 years in one primary health care centre was studied. The screening test consisted of an immunological method for the detection of faecal occult blood which was sent to the homes of the target population. Results: Participation was 46.6%, 11.7% of the tests were positive, and 79.3% agreed to have a colonoscopy. Eight adenocarcinomas and 32 patients with adenomas >0.4cm were diagnosed. Conclusions: The results obtained on the initial participation and the follow-up at five years suggest the viability of a CCR screening programme in our country (AU)

Multiple independent primary cancers do not adversely affect survival of the lung cancer patient.

OBJECTIVE: Diagnosis of multiple independent primary cancers is increasing in many settings. Objectives of this study were to analyze clinical characteristics, organ location, and prognosis associated with the presentation of multiple independent primaries when a lung cancer is involved. METHODS: We analyzed all patients with a histology-proven diagnosis of lung cancer registered from January 1990 to December 2004 at the Tumor Registry of the Hospital del Mar, Barcelona. We compared 1686 patients presenting a lung cancer as unique primary versus 228 patients presenting a lung cancer and another independent primary. Cofactors included age, sex, smoking habit, lung cancer histology and stage, type and intention of treatment, organ location of the other cancer, and survival from the date of lung cancer diagnosis. RESULTS: Seventy percent of the other cancers were tobacco-related. Independent risk factors of cancer multiplicity were smoking (OR: 3.99; 95% CI: 1.4-11.2), lung cancer stages I (OR: 1.84; 95% CI: 1.2-2.9) and II (OR: 3.25; 95% CI: 1.7-6.3), and older age (OR: 3.11; 95% CI: 1.9-5.1). Once adjusted by age and sex, the main determinant of survival was lung cancer stage rather than cancer multiplicity. However, patients with multiple cancers presented a slightly better survival than patients with a lung cancer as unique primary. When analyzed by subgroups, survival was higher in patients with the lung cancer first (HR: 0.44; 95% CI: 0.24-0.80), and in patients with the other cancer first (HR: 0.80; 95% CI: 0.65-0.99), but it was not different in the patients with a lung cancer and a synchronous other cancer (HR: 0.80; 95% CI: 0.52-1.15). CONCLUSIONS: The risk of developing a second independent cancer was strongly associated with tobacco smoking. Cancer multiplicity was not associated with a worse prognosis. As a consequence, when a first primary tobacco-related cancer is treated with curative intention, patients should be closely followed up for an early diagnosis of a possible new independent cancer; and if diagnosed, treatment to cure should be considered as the first option.

Influence of hormone replacement therapy on the accuracy of screening mammography.

The use of hormone replacement therapy (HRT) is currently a subject of debate because of the possibility of an increase in the incidence of breast cancer and difficulties associated with breast cancer detection. The objective of this study was to determine the influence of HRT on specificity and sensitivity in a breast cancer screening program. We found that although specificity was significantly lower in menopausal women who had ever used or were currently using HRT (93.3%) compared to HRT nonusers (94.8%) at the expense of a greater number of recalls (6.9% versus 5.6%), this difference seems to be clinically irrelevant. There were no significant differences with regard to the number of invasive procedures (2.5% in the HRT versus 2.1% in the control group). We conclude that the slight decrease in sensitivity of screening mammography in HRT users is not clinically significant in our setting, and in any case, false positives (recalled women) are diagnosed correctly with additional imaging studies without the need for invasive procedures. Most women given HRT are candidates to participate in population breast cancer screening campaigns.