The relationship between insecurity and the quality of hospital care provided to women with abortion-related complications in the Democratic Republic of Congo: A cross-sectional analysis.

OBJECTIVE: To examine the relationship between insecurity and quality of care provided for abortion complications in high-volume hospitals in the Democratic Republic of Congo (DRC). METHODS: Using the WHO Multi-Country Survey on Abortion complications, we analyzed data for 1007 women who received care in 24 facilities in DRC. For inputs of care, we calculated the percentage of facilities in secure and insecure areas meeting 12 readiness criteria for infrastructure and capability. For process and outcomes of care, we estimated the association between security and eight indicators using generalized estimating equation models. RESULTS: Facilities in secure areas were more likely to report functioning electricity (93.3% vs 66.7%), availability of an obstetrician 24/7 (42.9% vs 28.6%), and the ability to offer several short-acting contraceptives (83.3% vs 57.1%). However, a higher percentage of facilities in insecure areas reported the availability of a telephone or radio (100% vs 80.0%). Women in insecure areas appeared more likely to experience poor quality clinical care overall than women in secure areas (aOR 2.56; 95% CI, 1.13-5.82, P = 0.03). However, there was no association between security and incomplete medical records (P = 0.20), use of dilatation and curettage (D&C) (P = 0.84), women reporting poor experience of care (P = 0.22), satisfaction with care (P = 0.25), and severe maternal outcomes (P = 0.56). There was weak evidence of an association between security and nonreceipt of contraceptives (P = 0.07), with women in insecure areas 70% less likely to report no contraception (aOR 0.31, 95% CI, 0.09-1.09). Use of D&C was high in secure (43.7%) and insecure (60.4%) areas. CONCLUSION: Quality of care did not seem to be very different in secure and insecure areas in DRC, except for some key infrastructure, supply, and human resources elements. The frequent use of D&C for uterine evacuation, the lack of good record keeping, and the lack of contraceptives should be urgently addressed.

A Tissue-Engineered Human Psoriatic Skin Model to Investigate the Implication of cAMP in Psoriasis: Differential Impacts of Cholera Toxin and Isoproterenol on cAMP Levels of the Epidermis.

Pathological and healthy skin models were reconstructed using similar culture conditions according to well-known tissue engineering protocols. For both models, cyclic nucleotide enhancers were used as additives to promote keratinocytes' proliferation. Cholera toxin (CT) and isoproterenol (ISO), a beta-adrenergic agonist, are the most common cAMP stimulators recommended for cell culture. The aim of this study was to evaluate the impact of either CT or ISO on the pathological characteristics of the dermatosis while producing a psoriatic skin model. Healthy and psoriatic skin substitutes were produced according to the self-assembly method of tissue engineering, using culture media supplemented with either CT (10-10 M) or ISO (10-6 M). Psoriatic substitutes produced with CT exhibited a more pronounced psoriatic phenotype than those produced with ISO. Indeed, the psoriatic substitutes produced with CT had the thickest epidermis, as well as contained the most proliferating cells and the most altered expression of involucrin, filaggrin, and keratin 10. Of the four conditions under study, psoriatic substitutes produced with CT had the highest levels of cAMP and enhanced expression of adenylate cyclase 9. Taken together, these results suggest that high levels of cAMP are linked to a stronger psoriatic phenotype.

Improving pediatric TB diagnosis in North Kivu (DR Congo), focusing on a clinical algorithm including targeted Xpert MTB/RIF on gastric aspirates.

BACKGROUND: The incidence of tuberculosis (TB) in the Democratic Republic of the Congo (DRC) is 323/100,000. A context of civil conflict, internally displaced people and mining activities suggests a higher regional TB incidence in North Kivu. Médecins Sans Frontières (MSF) supports the General Reference Hospital of Masisi, North Kivu, covering a population of 520,000, with an elevated rate of pediatric malnutrition. In July 2017, an adapted MSF pediatric TB diagnostic algorithm, including Xpert MTB/RIF on gastric aspirates (GAs), was implemented. The aim of this study was to evaluate whether the introduction of this clinical pediatric TB diagnostic algorithm influenced the number of children started on TB treatment. METHODS: We performed a retrospective analysis of pediatric TB cases started on treatment in the inpatient therapeutic feeding centre (ITFC) and the pediatric ward. We compared data collected in the second half (July to December) of 2016 (before introduction of the new diagnostic algorithm) and the second half of 2017. For the outcome variables the difference between the two years was calculated by a Pearson Chi-square test. RESULTS: In 2017, 94 GAs were performed, compared to none in 2016. Twelve percent (11/94) of samples were Xpert MTB/RIF positive. Sixty-eight children (2.9% of total exits) aged between 3 months and 15 years started TB treatment in 2017, compared to 19 (1.4% of total exits) in 2016 (p 0.002). The largest increase in pediatric TB diagnoses in 2017 occurred in patients with a negative Xpert MTB/RIF result, but clinically highly suggestive of TB according to the newly introduced diagnostic algorithm. Fifty-two (3.1%) children under five years old started treatment in 2017, as compared to 14 (1.3%) in 2016 (p 0.004). The increase was less pronounced and not statistically significant in older patients: sixteen children (2.6%) above 5 years old started TB treatment in 2017 as compared to five (1.3%) in 2016 (p 0.17). CONCLUSION: After the introduction of an adapted clinical pediatric TB diagnostic algorithm, including Xpert MTB/RIF on gastric aspirates, we observed a significant increase in the number of children - especially under 5 years old - started on TB treatment, mostly on clinical grounds. Increased 'clinician awareness' of pediatric TB likely played an important role.

Manual and automated office measurements in relation to awake ambulatory blood pressure monitoring.

BACKGROUND: Automated blood pressure (BP) devices are commonly used in doctor's offices. How BP measured on these devices relates to ambulatory BP monitoring is not clear. OBJECTIVE: To assess how well office-based manual and automated BP predicts ambulatory BP. METHODS: Using data on 654 patients, we assessed how well sphygmomanometer measurements and measurements taken with an automated device (BpTRU) predicted results on ambulatory BP monitoring. We assess positive and negative predictive values and overall accuracy. We look at different cut-points for systolic (130, 135 and 140 mmHg) and diastolic (80, 85 and 90 mmHg) BP. RESULTS: A single automated office BP (AOBP) assessment provides superior predictive values and overall accuracy compared to three manual office BP assessments. For systolic BP, the predictive values are ≤69% for any of the cut-points while the positive predictive values for the single automated measurement is between 80.0% and 86.9% and the overall accuracy gets as high as 74% for the 130 mmHg cut-point. For diastolic BP, the automated readings are also more predictive but in this case, it is the negative predictive values that are better, as well as the overall accuracy. CONCLUSIONS: Based on the results, we suggest that 135/85 mmHg continue to be used as the cut-point defining high BP with the BpTRU device. However, future research might suggests that values in a grey zone between 130-139 mmHg systolic and 80-89 mmHg diastolic be confirmed using ambulatory BP monitoring. As well, three AOBP assessments might produce much greater accuracy than the single AOBP assessment used in the study.

Family medicine research capacity building: five-weekend programs in Ontario.

PROBLEM BEING ADDRESSED: Research is not perceived as an integral part of family practice by most family physicians working in community practices. OBJECTIVE OF THE PROGRAM To assist community-based practitioners in answering research questions that emerge from their practices in order for them to gain a better understanding of research and its value. PROGRAM DESCRIPTION: The Ontario College of Family Physicians developed a program consisting of 5 sets of weekend workshops, each 2 months apart. Two pilots of the 5-weekend program occurred between 2000 and 2003. After the pilots, thirteen 5-weekend programs were held in 2 waves by 20 facilitators, who were trained in one of two 1-day seminars. CONCLUSION: This 5-weekend program, developed and tested in Ontario, stimulates community practitioners to learn how to answer research questions emerging from their practices. A 1-day seminar is adequate to train facilitators to successfully run these programs. Evaluations by both facilitators and program participants were very positive, with many participants stating that their clinical practices were improved as a result of the program. The program has been adapted for residency training, and it has already been used internationally.

Effectiveness of a protocol-based strategy for achieving better blood pressure control in general practice.

BACKGROUND: There continues be a problem with the proportion of treated hypertension patients who are actually at recommended blood pressure targets. OBJECTIVE: Is an intensive protocol-based strategy for achieving blood pressure control effective in family practice and will family physicians and their hypertensive patients adhere to such a protocol. METHODS: Design of the study is a cluster randomized controlled trial at the Centre for Studies in Primary Care, Queen's University, Kingston, Ontario. Participants were 19 family physicians and 156 (98 intervention group and 58 control group) of their patients in and around the Kingston area. Patients were eligible if they had a diagnosis of hypertension and had not yet achieved their target blood pressure. Patients in the intervention group were managed according to a protocol that involved seeing their family doctor every 2 weeks over a 16-week period and having their antihypertensive medication regimen adjusted at each visit if target was not achieved. This was compared to usual care. Main outcomes were primary effectiveness outcome measured at 12 months was the differences in blood pressure between baseline and 12 months in the two groups. Secondary effectiveness outcomes included rates of achieving BP target and compliance with protocol by physicians and patients. Adherence outcomes were assessed by determining the number of visits made during the 16-week intervention period and the increase in the number of drugs being used. RESULTS: Of the patients enrolled, 72 (74%) from the intervention group and 41 (71%) in the control group were available for analysis. Improvement between baseline and 12-month follow-up was significantly better for the intervention group than the control for diastolic mean daytime BP on 24 hours ambulatory blood pressure monitoring (4.5 mmHg reduction versus 0.5 mmHg reduction) and for both systolic (14.7 mmHg reduction versus 2.7 mmHg reduction) and diastolic (7.4 mmHg reduction versus 0.6 mmHg increase) blood pressure on BpTRU. Of the 98 patients in the intervention, 80% attended four or more of the eight visits and 25% attended all eight visits; physicians increased the number or dosage of drugs the patient was taking in 52% of the visits. Conclusions. An intensive, protocol-based, management approach to achieving blood pressure control in hypertensive patients in family practice is effective and works even when there is flexibility built into the algorithm to allow family physicians to use their judgement in individual patients.

A primary care pragmatic cluster randomized trial of the use of home blood pressure monitoring on blood pressure levels in hypertensive patients with above target blood pressure.

BACKGROUND: The measurement of blood pressure (BP) at home by patients with hypertension is increasingly used to assess and monitor BP. Evidence for its effectiveness in improving BP control is mixed. METHODS: To determine if home BP monitoring improves BP a pragmatic cluster randomized contolled trial was carried out in family practices in southeastern Ontario, Canada. Family practice patients with uncontrolled hypertension were recruited to the trail. Patients were divided into two groups: one with at least weekly measurements of BP at home, recording those measurements and showing those to the family physician during office visits for hypertension and the control group were given usual care. The primary outcome was mean awake BP on ambulatory monitoring at 6- and 12-month follow-up and the secondary outcomes were mean BP on full 24-hour ambulatory blood pressure monitoring (ABPM), mean sleep BP on ABPM and BP on the BpTRU device, all at 6- and 12-month follow-up. RESULTS: Home BP monitoring did not improve BP compared to usual care at 12-month follow-up: mean awake systolic BP on ABPM [141.1 versus 142.8 mmHg, mean difference 1.7 mmHg; 95% confidence interval (CI) -0.6 to 4.0, P = 0.314] and mean awake diastolic BP on ABPM (78.7 versus 79.4 mmHg, mean difference 0.7 mmHg; 95% CI -7.7 to 9.1, P = 0.398). Similar negative results were obtained for men and women separately. However, outcomes using the full 24-hour ABPM and the BpTRU device showed a significantly lower diastolic BP at 12 months. When analysis was done by sex, this effect was shown to be only in men. CONCLUSION: Home BP monitoring may improve BP control in men with hypertension.

Care of the elderly training: Implications for family medicine.

OBJECTIVE: To examine the practice patterns and clinical and academic roles of family physicians who have care of the elderly training. DESIGN: Cross-sectional survey. SETTING: Family medicine practices or specialized geriatric services programs. PARTICIPANTS: Fifty-two family physicians, surveyed in 2005 and 2006, identified as having 6 or 12 months' care of the elderly training. MAIN OUTCOME MEASURES: Self-reported practice type and description of clinical and academic roles. RESULTS: Surveys were sent to 103 physicians; the response rate was 50.5% (N = 52). Respondents were relatively young, with a mean age of 42 years. Slightly more respondents had completed 6 months of training than had completed a full year of training (54.9% vs 45.1%). More than half (55.8%) described their medical practice areas as "general family medicine." The remainder worked in "restricted practices" (25.0%) or provided "specialist care" (17.3%); 1 physician was no longer practising medicine. Many provided some care within specialized geriatric service areas, most commonly in-hospital consultation and rehabilitation. More than half (51.9%) provided active hospital care, and a substantial number worked in long-term care facilities as physicians or medical directors. More than 20% provided newborn care, although only a small percentage (7.7%) performed obstetric services. Respondents were actively involved in teaching and other academic activities, including resident supervision. CONCLUSION: Care of the elderly physicians provide comprehensive family medicine services, but also often provide care in other areas currently facing physician shortages. Care of the elderly physicians play relevant clinical and academic roles in both family medicine training and specialized geriatric services.

Testing the Simple Lifestyle Indicator Questionnaire: Initial psychometric study.

OBJECTIVE: To carry out initial psychometric testing on the Simple Lifestyle Indicator Questionnaire (SLIQ). DESIGN: Self-administered questionnaire to obtain data for test-retest reliability, for Cronbach alpha testing on completed questionnaires, and for blinded external validity testing. SETTING: Kingston, Ont, and surrounding area. PARTICIPANTS: One hundred thirty-six family practice patients with an mean age of 68 years; 58% were women. Subjects were primarily white and living in a small city and itsrural surroundings. MAIN OUTCOME MEASURES: Test-retest coefficients, Cronbach alpha values, and correlation coefficients. RESULTS: Test-retest reliability on the 12 questions ranged from 0.63 to 0.97. The Cronbach alpha was 0.58 for questions on diet and 0.6 for questions on physical activity. We found a correlation coefficient of 0.77 between participants' and blinded raters' scores on the SLIQ. CONCLUSION: The SLIQ, as currently tested, is likely suitable for use in research on people who are at least similar to those in our study population. It probably should not be used in clinical settings until further testing has been carried out.

A cross sectional survey of urban Canadian family physicians' provision of minor office procedures.

BACKGROUND: A discordance exists between the proportion of Canadian family physicians that we expect should be able to perform minor office procedures and the actual provision of care. This pattern has not been extensively studied. The objective of this study was to determine the current patterns and obstacles relating to the provision of four minor office procedures by GP/FPs in a small city in Ontario, Canada. An additional goal was to determine the impact of the remuneration method on the provision of such services. METHODS: A survey was mailed to all GP/FPs practising in Kingston, Ontario. The main outcomes measured in the study were work setting and remuneration method, current procedural practices with respect to four procedures, reasons for not performing procedures, current skill levels, and desire to upgrade. RESULTS: Surveys were mailed to all 108 GP/FPs in the City of Kingston. Completed surveys were collected for 82 percent (89/108) and 10 were excluded leaving 79 eligible participants. The percentages of GP/FPs who reported performing the procedure were as follows: dermatological excision (63.3%), endometrial biopsy (35.4%), shoulder injection (31.6%), and knee injection (43.0%). The majority of GP/FPs who would not do the procedure themselves would refer to a specialist colleague rather than to another GP/FP. The top reason cited for not performing a specific procedure was "lack of up to date skills" followed by "lack of time". The latter was the only statistically significant difference reported between GP/FPs working in Family Health Networks and GP/FPs working in fee for service settings (26.7% vs 47.0%, chi2 = 4.191 p = 0.041). CONCLUSION: A large number of Kingston, Ontario GP/FPs refer patients who require one of four minor office-based procedures for specialist consultation. Referral to other GP/FP colleagues appears underutilized. A perceived lack of up to date skills and a lack of time appear to be concerns. GP/FPs working in Family Health Networks were more likely to perform these procedures themselves. Further studies would clarify the role of changes in medical education, the role of continuing education, and the impact of different remuneration models.

Family medicine anesthesia: sustaining an essential service.

OBJECTIVE: To elicit the opinions of family physician anesthetists (FPAs) and hospital Chief Executive Officers (CEOs) regarding the structure of their organizations and the importance of family medicine anesthesia. DESIGN: Mailed survey. SETTING: Ontario hospitals. PARTICIPANTS: The CEOs of Ontario hospitals and family physicians who provide anesthetic services in Ontario hospitals. MAIN OUTCOME MEASURES: Demographics, practices, and opinions of FPAs and CEOs regarding family medicine anesthesia. RESULTS: Responses were received from 159 of 195 practising FPAs (82%). Of the 128 hospitals in Ontario that offered anesthesia services, 59% used at least one FPA; in 39% of these hospitals, all services were provided by FPAs. Both FPAs and CEOs thought that FPAs were competent to meet the anesthesia needs of small community hospitals. Most FPAs and CEOs supported certification and maintenance of competence programs coordinated by a national body, such as the College of Family Physicians of Canada. Both FPAs and CEOs thought there should be support for additional training programs in family medicine anesthesia. CONCLUSION: Small community hospitals rely completely on FPAs to provide essential anesthesia services. Additional training programs and a national structure to coordinate certification and maintenance of competence programs are important to maintain and enhance this essential service.

Faculty's and residents' perceptions of teaching and evaluating the role of health advocate: a study at one Canadian university.

PURPOSE: To examine the views of faculty and residents about teaching and evaluating health advocacy, one of the more difficult CanMEDS roles to integrate into postgraduate medical education. METHOD: In 2002, two focus groups of faculty and two of residents at Queen's University, Kingston, Ontario, Canada, were asked standardized questions to elicit their answers to what was a health care advocate as understood and reported by teachers and residents, and what were the reported barriers and enhancers to teaching and evaluating the role of residents as health care advocates. RESULTS: The study found that faculty and residents knew little about how to teach and evaluate the role of the health advocate. There was consensus between the two types of groups with congruity between residents and faculty about the key issues. The one exception to this was the disconnect between the faculty members' belief that advocacy was an aspect of their daily work and the residents' apparent lack of awareness of this. The majority of participants were not familiar with the Royal College's description of the role of health advocate and were very keen to receive further guidance on teaching tools and methods of evaluation. CONCLUSION: The authors' hypothesis was that little is known about how to teach and evaluate the role of the health advocate. The results confirmed this and identified important areas upon which to build an educational framework. The definition of the health advocate and the expectations require clarity and direction. Academic programs would benefit from clear objectives.

Medical Students' and Residents' preferred site characteristics and preceptor behaviours for learning in the ambulatory setting: a cross-sectional survey.

BACKGROUND: Medical training is increasingly occurring in the ambulatory setting for final year medical students and residents. This study looks to identify if gender, school, level of training, or specialty affects learner's (final year medical students and residents) preferred site characteristics and preceptor behaviours for learning in the ambulatory setting. METHODS: All final year medical students and residents at the five medical schools in Ontario (N = 3471) were surveyed about the site characteristics and preceptor behaviours most enhancing their learning in the ambulatory setting. Preferred site characteristics and preceptor behaviours were rank ordered. Factor analysis grouped the site characteristics and preceptor behaviours into themes which were then correlated with gender, school, level of training, and specialty. RESULTS: Having an adequate number and variety of patients while being supervised by enthusiastic preceptors who give feedback and are willing to discuss their reasoning processes and delegate responsibility are site characteristics and preceptor behaviours valued by almost all learners. Some teaching strategies recently suggested to improve efficiency in the ambulatory teaching setting, such as structuring the interview for the student and teaching and reviewing the case in front of the patient, were found not to be valued by learners. There was a striking degree of similarity in what was valued by all learners but there were also some educationally significant differences, particularly between learners at different levels and in different specialties. Key findings between the different levels include preceptor interaction being most important for medical students as opposed to residents who most value issues pertaining to patient logistics. Learning resources are less valued early and late in training. Teaching and having the case reviewed in front of the patient becomes increasingly less valued as learners advance in their training. As one approaches the end of ones' training office management instruction becomes increasingly valued. Differences between specialties pertain most to the type of practice residents will ultimately end up in (ie: office based specialties particularly valuing instruction in office management and health care system interaction). CONCLUSIONS: Preceptors need to be aware of, and make efforts to provide, teaching strategies such as feedback and discussing clinical reasoning, that learners have identified as being helpful for learning. If strategies identified as not being valued for learning, such as teaching in front of the patient, must continue it will be important to explore the barriers they present to learning. Although what all learners want from their preceptors and clinic settings to enhance their learning is remarkably similar, being aware of the educationally significant differences, particularly for learners at different levels and in different specialties, will enhance teaching in the ambulatory setting.

E-mail or snail mail? Randomized controlled trial on which works better for surveys.

OBJECTIVE: To compare e-mail with regular mail for conducting surveys of physicians. DESIGN: Randomized controlled trial. SETTING: Ontario, Canada. PARTICIPANTS: A random sample of physicians listed in the College of Family Physicians of Canada's membership database. INTERVENTIONS: Survey delivered by e-mail and by post. MAIN OUTCOME MEASURES: Response rates and times, and completeness and characteristics of responses to the survey. RESULTS: Overall response rate was 44.7% (33.6% of e-mail recipients, 52.7% of post recipients who have e-mail, and 47.8% of post recipients without e-mail). While the e-mail rate was significantly lower than for both post groups, e-mail responses were received much faster. There was no significant difference among groups as to completeness of responses, but e-mail responses had more frequent and longer comments. CONCLUSION: E-mail provides faster but fewer responses to surveys. Content of structured-response questions was similar in all groups, but e-mail provided more and longer responses to open-ended questions. Where a quick response to a survey is required, e-mail is superior.

Relationship between blood pressure measurements recorded on patients' charts in family physicians' offices and subsequent 24 hour ambulatory blood pressure monitoring.

BACKGROUND: In most western countries 20% of adults have hypertension. Reports in the literature suggest that from 31 to 86% of treated patients are not at recommended target levels. However it is important to consider how we are determining whether targets are unmet and the degree to which they are unmet. Our underlying hypothesis is that white coat effect is partially responsible for the reported low rates of control of hypertension by primary care practitioners. METHODS: The study population consists of 1142 patients who are being assessed for enrollment in two community-based randomized controlled trials. Patients must have essential hypertension, be on antihypertensive medication, and must not have met their blood pressure targets. We are reporting on the proportion of patients who have not achieved target, and the degree to which they have not achieved their target. We also report on the mean daytime blood pressures on 24 hour ABPM and compare these to mean blood pressures found on the patients' charts. RESULTS: We identified 3284 patient charts of patients with hypertension. Of these, 1142 were determined to be "out of control" (did not achieve target) and 436 agreed to undergo 24 hour ABPM for final determination of eligibility. Overwhelmingly (95.8% of the time) it was the systolic blood pressure that was not under control. However, most of the patients who had not achieved target according to our criteria were within 10 mmHg of the recommended targets. Isolated systolic blood pressure was the best predictor of elevated mean daytime blood pressure on 24 hour ABPM. CONCLUSIONS: At least 35% of patients had not achieved target blood pressure levels and this is primarily due to lack of control of systolic blood pressure. The best predictor of continuing hypertension on 24 hour ABPM was the mean systolic blood pressure on the patients chart. However, only 69% of patients who were uncontrolled according blood pressures recorded in the chart were uncontrolled according to 24 hour ABPM criteria. This suggests that the white coat effect makes blood pressure measurements in the doctor's offices, at least as currently done, not sufficiently accurate for determining treatment endpoint.

Randomised equivalence trial comparing three month and six month follow up of patients with hypertension by family practitioners.

OBJECTIVE: To compare blood pressure control, satisfaction, and adherence to drug treatment in patients with treated hypertension followed up by their family physicians either every three months or every six months for three years. DESIGN: Randomised equivalence clinical trial. Settings 50 family practices in south eastern Ontario, Canada. PARTICIPANTS: 609 patients aged 30-74 years with essential hypertension receiving drug treatment whose hypertension had been controlled for at least three months before entry into the study. RESULTS: 302 patients were randomly assigned to follow up every three months and 307 to follow up every six months. Baseline variables in the two groups were similar. As expected, patients in the six month group had significantly fewer visits, but patients in both groups visited their doctor more frequently than their assigned interval. Mean blood pressure was similar in the groups, as was control of hypertension. Patient satisfaction and adherence to treatment were similar in the groups. About 20% of patients in each group had blood pressures that were out of control during the study. CONCLUSIONS: Follow up of patients with treated essential hypertension every six months is equivalent to follow up every three months. Patient satisfaction and adherence to treatment are the same for these follow up intervals. As about 20% of patients' hypertension was out of control at any time during the study in both groups, the frequency of follow up may not the most important factor in the control of patients' hypertension by family practitioners.

Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity.

BACKGROUND: Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results) and internal validity (reliability or accuracy of the results) needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. DISCUSSION: External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. SUMMARY: Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results) and external validity (generalizability). The attempt to achieve methodological purity can result in clinically meaningless results, while attempting to achieve full generalizability can result in invalid and unreliable results. Achieving a creative tension between the two is crucial.

Critical appraisal skills of family physicians in Ontario, Canada.

BACKGROUND: Our primary objective in this study was to measure family physicians' knowledge of the key elements that go into assessing the validity and interpreting the results in three different types of studies: i) a randomized controlled trial (RCT); ii) a study evaluating a diagnostic test; and iii) a systematic review (SR). Our secondary objectives were to determine the relationship between the above skills and age, gender, and type of practice. METHODS: We obtained a random sample of 1000 family physicians in Ontario from the College of Family Physicians of Canada database. These physicians were sent a questionnaire in the mail with follow-up mailings to non-responders at 3 and 8 weeks. The questionnaire was designed to measure knowledge and understanding of the basic concepts of critical appraisal skills. Based on the responses to the questions an Evidence Based Medicine (EBM) Knowledge Score was determined for each physician. RESULTS: A response rate of 30.2% was achieved. The respondents were younger and more likely to be recent graduates than the population of Ontario Family Physicians as a whole. This was an expected outcome. Just over 50% of respondents were able to answer questions concerning the critical appraisal of methods and the interpretation of results of research articles satisfactorily. The average score on the 12-point EBM Knowledge Scale was 6.4. The younger physicians scored higher than the older physicians, and academic physicians scored higher than community-based physicians. Scores of male and female physicians did not differ. CONCLUSIONS: We have shown that in a population of physicians which is younger than the general population of physicians, about 50% have reasonable knowledge regarding the critical appraisal of the methods and the interpretation of results of a research article. In general, younger physicians were more knowledgeable than were older physicians. EBM principles were felt to be important to the practice of medicine by 95% of respondents.