Evaluation of the Stroke-Specific Quality-of-Life (SSQOL) Scale in Mexico: A Preliminary Approach.

OBJECTIVES: The prevalence of stroke survivors with incomplete recovery in society has been estimated at 460/100,000 people, and one third of them require help in at least one daily activity. Two thirds of all deaths related to stroke in the world occur in low- and middle-income countries. The objective of the present work was to assess the reliability and validity of the previously translated Spanish Stroke-Specific Quality-of-Life (SSQOL) version 2.0 scales in Mexican stroke survivors. METHODS: An observational and cross-sectional pilot study was conducted. Thirty-one patients who suffered stroke up to 1 year prior to the present study were included. Patients were interviewed twice in a 7-day period; other indexes and scales were applied. The reliability was assessed by using Cronbach's alpha (internal consistency) and test-retest by using Spearman's rho scores; the acceptability was evaluated by the floor and ceiling effects. RESULTS: Ceiling and floor effects were observed for fewer than 20% of the patients. The overall internal consistency of the questionnaire was greater than 0.7 (Cronbach's α), with only two domains (family roles and personality) having lower internal consistency values. The results displayed high test-retest reliability: all domains had Spearman's rho scores of over 0.8. The questionnaire has adequate construct validity. CONCLUSIONS: Our preliminary results showed that the psychometric properties (acceptability and reliability) of the Spanish SSQOL questionnaire are good, encouraging, and comparable to those of other similar studies. This study is the first approach to validate the Spanish version of the SSQOL questionnaire in Mexican stroke survivors.

Evaluation of completeness of suspected adverse drug reaction reports submitted to the mexican national pharmacovigilance centre: a cross-sectional period-prevalence study.

BACKGROUND: The Mexican National Centre of Pharmacovigilance (CNFV) receives suspected adverse drug reaction (ADR) reports from the pharmaceutical industry, Federal States Centre of Pharmacovigilance (CEFV) and Healthcare Institution Centres of Pharmacovigilance (CIFV). The completeness of these suspected ADR reports is particularly important for the proper evaluation of drug safety. OBJECTIVE: The aim of the study was to evaluate the completeness of the information reported in a representative sample of suspected ADR reports submitted to the CNFV during 2007 and 2008, to evaluate the completeness of the suspected ADR reports submitted to the CNFV from different sources during these 2 years and to identify the therapeutic subgroups with the highest number of suspected ADR reports during the study years. METHODS: A cross-sectional period-prevalence study was conducted at the CNFV. Only reports of suspected ADRs submitted by the CEFV, pharmaceutical industry and CIFV during 2007 and 2008 were included in the present study (reports related to vaccines were excluded). The sample sizes to be used for each year were determined using the formula for population rate at 95% significance level. The samples for each year were randomly selected from the reports related to synthetic drugs submitted that year. The suspected ADR reports were classified according to the standing Mexican Official Norm (Norma Oficial Mexicana [NOM]) guidelines, which were used to divide the reports into four categories (0, 1, 2 and 3) based on their completeness. The seriousness of the suspected ADRs reported was also evaluated; a suspected ADR was classified as 'non-serious' when signs and symptoms are likely to be tolerated, 'moderate' when ADR is not life threatening and needs pharmacological treatment, 'serious' when ADR is life threatening and leads to hospitalization and 'fatal' when ADR contributes directly or indirectly to the patient's death. RESULTS: A total sample size of 370 and 371 suspected ADR reports from 2007 and 2008, respectively, were examined. Our analysis revealed that the pharmaceutical industry sent the highest number of suspected ADR reports for both years (58% and 63%, respectively). Results of the information completeness analysis by using the NOM categories showed that, in both study years, among the total suspected ADR reports about 32% (119) and 40% (148), respectively, were categorized as grade 0 (information insufficient to generate risk signals). Analyses of the seriousness of all suspected ADR reports revealed that 2% of reports were classified as fatal each year, whereas 6% and 5% were classified as serious and 25% and 29% were classified as moderate in 2007 and 2008, respectively. The therapeutic subgroups, according to the Anatomical Therapeutic Chemical classification, with the highest frequencies of suspected ADR reports in both study years were sex hormones and modulators of the genital system, antibacterial for systemic use, antiepileptics and psychoanaleptics, and antihypertensives. CONCLUSIONS: The completeness of the information provided in the suspected ADR reports submitted during the sample study years was incomplete and, in general, did not fulfil the requirements established by the NOM guidelines. Among the pharmaceutical industry, CEFV and CIFV, the suspected ADR reports were mainly provided by the pharmaceutical industry. It is necessary to improve the pharmacovigilance system in Mexico to achieve a high level of completeness of suspected ADR reports that totally fulfil the standing regulations.

Cost-effectiveness study of oral hypoglycemic agents in the treatment of outpatients with type 2 diabetes attending a public primary care clinic in Mexico City.

INTRODUCTION: Worldwide, diabetes mellitus presents a high burden for individuals and society. In Latin America, many people with diabetes have limited access to health care, which means that indirect costs may exceed direct health care cost. Diabetes is Mexico's leading cause of death. PURPOSE: To evaluate the cost-effectiveness ratios of the most used oral hypoglycemic agents (OHA) in the treatment of outpatients with type 2 diabetes attending a public primary care clinic in Mexico City. DESIGN: A cross-sectional and analytic study was conducted in Mexico City. METHODOLOGY: Twenty-seven adult outpatients with type 2 diabetes who were treated either with metformin or glibenclamide were included. Acarbose was used as an alternative strategy. The study was carried out from the perspective of Mexican society. Direct medical and nonmedical costs as well as indirect costs were evaluated using a structured questionnaire. Efficacies of all drug treatments were evaluated retrospectively. A systematic search was conducted to select published randomized clinical trials based on predetermined inclusion criteria, and treatment success was defined as glycosylated hemoglobin factor ≤ 7%. Efficacy data of each drug and/or combination were analyzed using meta-analysis. The Monte Carlo Markov model was used. Quality-adjusted life-years (QALY) were used as the unit of effectiveness; incremental and sensitive analyses were performed and a 5% discount rate was calculated. A hypothetical cohort of 10,000 patients was modeled. RESULTS: The odds ratios of the success of each drug treatment were obtained from the meta-analyses, and were the following: 5.82 (glibenclamide), 3.86 (metformin), 3.5 (acarbose), and 6.76 (metformin-glibenclamide). The cost-effectiveness ratios found were US$272.63/QALY (glibenclamide), US$296.48/QALY (metformin), and US$409.86/QALY (acarbose). Sensitivity analysis did not show changes for the most cost-effective therapy when the effectiveness probabilities or treatment costs were modified. CONCLUSION: Glibenclamide is the most cost-effective treatment for the present study outpatient population diagnosed with type 2 diabetes in the early stages.

Potential prescription patterns and errors in elderly adult patients attending public primary health care centers in Mexico City.

INTRODUCTION: Six out of every 10 elderly persons live in developing countries. OBJECTIVE: To analyze and assess the drug prescription patterns and errors in elderly outpatients attending public health care centers in Mexico City, Mexico. MATERIALS AND METHODS: A descriptive and retrospective study was conducted in 2007. Fourteen hundred prescriptions were analyzed. Prescriptions of ambulatory adults aged >70 years who were residents of Mexico City for at least two years were included. Prescription errors were divided into two groups: (1) administrative and legal, and (2) pharmacotherapeutic. In group 2, we analyzed drug dose strength, administration route, frequency of drug administration, treatment length, potential drug-drug interactions, and contraindications. Variables were classified as correct or incorrect based on clinical literature. Variables for each drug were dichotomized as correct (0) or incorrect (1). A Prescription Index (PI) was calculated by considering each drug on the prescription. SPSS statistical software was used to process the collected data (95% confidence interval; p <0.05). RESULTS: The drug prescription pattern in elderly outpatients shows that 12 drugs account for 70.72% (2880) of prescribed drugs. The most prescribed drugs presented potential pharmacotherapeutic errors (as defined in the present study). Acetylsalicylic acid-captopril was the most common potential interaction (not clinically assessed). Potential prescription error was high (53% of total prescriptions). Most of the prescription errors were due to omissions of dosage, administration route, and length of treatment and may potentially cause harm to the elderly outpatients. CONCLUSIONS: A high number of potential prescription errors were found, mainly due to omissions. The drug prescription pattern of the study population is mainly constituted by 12 drugs. The results indicate that prescription quality depends on the number of prescribed drugs per prescription (p < 0.000).

Breast cancer quality of life evaluation in Mexican Women at La Raza Hospital, Mexico City: A preliminary approach.

Breast cancer (BC) is the second leading cause of death among Mexican women over 40 years of age. This study aimed to identify and examine the effects of cancer stage and surgical treatment on the quality of life (QOL) of Mexican women with early stage breast cancer (ESBC) treated with either modified radical mastectomy (MRM) or breast conservative surgery (BCS), plus adjuvant chemotherapy. The QLQ-C30 and QLQ BR-23 questionnaires were used to assess QOL. Sociodemographic characteristics and clinical factors of 102 women with early BC were also evaluated; analysis of variance (ANOVA) was performed and a statistical significance of p < 0.05 was assumed. Most women were of reproductive age. Meaningful differences in QOL as a result of surgical treatment, in women receiving BCS compared with those receiving MRM, were limited to body image. We conclude that MRM and BCS are essentially equivalent choices in terms of QOL, with the exception of the impact on body image. In general, women who received BCS had a better perceived QOL.

The costs of breast cancer in a Mexican public health institution.

Breast cancer (BC) is the second leading cause of death as a result of neoplasia in Mexico. This study aimed to identify the direct and indirect costs of treating female outpatients diagnosed with BC at a Mexican public hospital. A cross-sectional, observational, analytical study was conducted. A total of 506 medical records were analyzed and 102 were included in the cost analysis. The micro-costing process was used to estimate treatment costs. A 17-item questionnaire was used to obtain information on direct and indirect costs. Of the 102 women with BC included in the study, 92.2% (94) were at Stage II, and only 7.8% at Stage I. Total direct costs over six months for the 82 women who had modified radical mastectomy (MRM) surgury were US$733,821.15. Total direct costs for the 15 patients with conservative surgery (CS) were US$138,190.39. We found that the total economic burden in the study population was much higher for patients with MRM than for patients with CS.