Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

BACKGROUND: The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency. METHODS/DESIGN: The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses. DISCUSSION: The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

[Research and protection of personal data in Primary Care]. / Investigación y protección de datos personales en atención primaria.

Research is one of the fundamental functions that have to be carried out in Primary Care. The clinical information stored in different records arising from medical care is a basic tool for this activity. The use of personal data for the purposes of research is legitimate according to our laws; however, this information must be treated confidentially at all times. Two alternatives are available for this. One is to obtain the informed consent of the patient, and the other is to dissociate the handling of the information. But in some situations, the compliance to legal demands when obtaining data for research is not easy, there being a series of obstacles which in many cases makes it impossible to carry out research. In this article, we will give guidance on how to access the information contained in records while respecting the rights of the patient and the current legislation.

EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting.

BACKGROUND: High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a cardiovascular risk visual learning method--the EDUCORE method--is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD; METHODS/DESIGN: This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure >or= 140 mmHg and/or diastolic >or= 90 mmHg). All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded; DISCUSSION: The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting; TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov].

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).

OBJECTIVES: To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. DESIGN: Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). PARTICIPANTS: 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. INTERVENTIONS: The IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. MAIN OUTCOMES: Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. RESULTS: The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were -0.7% (133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were -6.3% (103 out of 112 vs 115 out of 117; 95% CI: -11.9 to -0.1; p=0.025) and -6.8% (103 out of 140 vs 115 out of 143; 95% CI: -16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>-10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. CONCLUSIONS: Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low. TRIAL REGISTRATION NUMBERS: NCT01476007; EUDRACT (2010-024129-20).

A primary healthcare information intervention for communicating cardiovascular risk to patients with poorly controlled hypertension: The Education and Coronary Risk Evaluation (Educore) study-A pragmatic, cluster-randomized trial.

PURPOSE: Uncertainty exists regarding the best way to communicate cardiovascular risk (CVR) to patients, and it is unclear whether the comprehension and perception of CVR varies according to the format used. The aim of the present work was to determine whether a strategy designed for communicating CVR information to patients with poorly controlled high blood pressure (HBP), but with no background of cardiovascular disease, was more effective than usual care in the control of blood pressure (BP) over the course of a year. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial was performed. Consecutive patients aged 40-65 years, all diagnosed with HBP in the last 12 months, and all of whom showed poor control of their condition (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg), were recruited at 22 primary healthcare centres. Eleven centres were randomly assigned to the usual care arm, and 11 to the informative intervention arm (Educore arm). At the start of the study, the Educore arm subjects were shown the "low risk SCORE table", along with impacting images and information pamphlets encouraging the maintenance of good cardiovascular health. The main outcome variable measured was the control of HBP; the secondary outcome variables were SCORE table score, total plasma cholesterol concentration, use of tobacco, adherence to prescribed treatment, and quality of life. RESULTS: The study participants were 411 patients (185 in the Educore arm and 226 in the usual care arm). Multilevel logistic regression showed that, at 12 months, the Educore intervention achieved better control of HBP (OR = 1.57; 1.02 to 2.41). No statistically significant differences were seen between the two arms at 12 months with respect to the secondary outcomes. CONCLUSIONS: Compared to usual care, the Educore intervention was associated with better control of HBP after adjusting for age, baseline SBP and plasma cholesterol, at 12 months.

Information needs and information-seeking behavior of primary care physicians.

PURPOSE: The aim of this study was to determine the information needs of primary care physicians in Spain and to describe their information-seeking patterns. METHODS: This observational study took place in primary care practices located in Madrid, Spain. Participants were a random stratified sample of 112 primary care physicians. Physicians' consultations were video recorded for 4 hours. Clinical questions arising during the patient visit and the sources of information used within the consultation to answer questions were identified. Physicians with unanswered questions were followed up by telephone 2 weeks later to determine whether their questions had since been answered and the sources of information used. Clinical questions were classified by topic and type of information. RESULTS: A total of 3,511 patient consultations (mean length, 7.8 minutes) were recorded, leading to 635 clinical questions (0.18 questions per consultation). The most frequent questions were related to diagnosis (53%) and treatment (26%). The most frequent generic type of questions was "What is the cause of symptom x?" (20.5%). Physicians searched for answers to 22.8% of the questions (9.6% during consultations). The time taken and the success rate in finding an answer during a consultation and afterward were 2 minutes (100%) and 32 minutes (75%), respectively. CONCLUSIONS: Primary care physicians working in settings where consultations are of short duration have time to answer only 1 in 5 of their questions. Better methods are needed to provide answers to questions that arise in office practice in settings where average consultation time is less than 10 minutes.

[Study of the Information requirements generated by primary care doctors (ENIGMA Project)]. / Estudio de las necesidades de información generadas por los médicos de atención primaria (proyecto ENIGMA).

OBJECTIVES: To determine the information needs of primary care physicians by identifying the frequency and type of questions arising during consultation, and by describing the information-search pattern. DESIGN. Observational, descriptive, multi-centre study. SETTING: Primary care practices in Madrid, Spain. PARTICIPANTS: Random sample, proportionally stratified by area (urban/rural) and specialty (general practitioner/paediatrician), of 208 primary care physicians out of a total of 1182 physicians; 112 agreed to take part. INTERVENTIONS: Physicians consultations were video-recorded for four hours. Between patients, they were asked to pose all the clinical questions arising during the patient visit and the sources of information used to answer them. Unresolved questions were followed up by phone 2 weeks later to check if answers had been found and what sources of information had been used. Clinical questions were classified by topic and type. MAIN MEASUREMENTS: Number of questions posed and their answers; topic and type of information; information resources used. RESULTS: A total of 3511 patient consultations, leading to 635 clinical questions, were recorded. The most frequent questions were on pharmacology (10%) for general practitioners, and infectious disease (19%) for paediatricians. The most frequent type of question was on the cause/interpretation of a clinical finding (44% for general practitioners and 48% for paediatricians). Answers to 39% of the questions were not sought. A 86% of the answers sought were solved, mainly using the drug compendium (35%) or a text-book (18%). CONCLUSIONS: Primary care physicians tried to resolve less than two-thirds of the questions asked, and mainly did so through readily available printed material. Better methods are needed to provide answers to questions that arise in clinical practice.

[Randomized clinical trial for primary care patients with neck pain: manual therapy versus electrical stimulation]. / Ensayo clínico aleatorizado en pacientes con cervicalgia mecánica en atención primaria: terapia manual frente a electroestimulación nerviosa transcutánea.

OBJECTIVE: To compare the effectiveness of manual therapy (MT) versus transcutaneous electrical nervous stimulation (TENS) in reducing the intensity of pain in patients with subacute or chronic neck pain (NP) attended at primary care physiotherapy units (PCPU). DESIGN: Randomised clinical trial. SETTING: Thirteen PCPU in 4 health districts of the Community of Madrid, Spain. PARTICIPANTS: Ninety patients with subacute or chronic NP attended. Lost after intervention: 3. INTERVENTIONS: At random, 47 patients were allocated to MT treatment and 43 to TENS. MAIN MEASUREMENTS: Social and demographic characteristics and prognosis variables in the intervention groups were measured. Intensity of pain before and after intervention was calculated by mean values on the analogue visual scale (present moment, average and worst pain of the last 2 weeks). Side-effects were also measured. RESULTS: Difference between before-and-after pain was 21.83 mm (95% CI, 13.71-29.95) for the group treated with Transcutaneous electrical nervous stimulation and 22.87 mm (95% CI, 17.11-28.64) for manual therapy. The difference in averages on comparing the 2 procedures for improvement was 1.04 (95% CI, -8.66% to 10.75%). CONCLUSIONS: TENS and MT significantly reduce patients' perceived intensity of pain, although there were no differences between the 2 groups.There are no conclusive results for the alternative physiotherapy treatments that determine a clear strategy of intervention.