Case-control study on analgesics and nephropathy (SAN): protocol

BACKGROUND: The association between intake of non-phenacetin-containing analgesics and the occurrence of chronic renal failure is still controversially discussed. A new epidemiologic study was planned and conducted in Germany and Austria. METHODS/DESIGN: The objective of the international, multicenter case-control study was to evaluate the association between end-stage renal disease (ESRD) and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations. A targeted sample of 1000 new (incident) dialysis patients, aged less than 50 years, was planned to recruit between January 1, 2001 and December 31, 2004. The age limit was chosen to avoid contamination of the study population with phenacetin-containing analgesics to the extent possible. Four control subjects per ESRD case, matched by age, sex, and region were selected from the population living in the region the case came from. Lifetime exposure to analgesics and potential renal risk factors were recorded in a single face-to-face interview. A set of aids was introduced to reinforce the memory of study participants. A standardized, pre-tested interview questionnaire (participants), a medical documentation sheet (physicians in dialysis centres), a logbook for all activities (dialysis centres) were used to collect the necessary data. Quality management consisted of the standardized procedures, (re-) training and supervision of interviewers, regular checks of all incoming data for completeness and plausibility. The study is scientifically independent and governed by a international Scientific Advisory Committee that bridged the gap between the sponsoring companies and the investigators. Also other advisory groups assisted the managing committee of the study. All relevant German and Austrian nephrological associations supported the study, and the study design was carefully reviewed and approved by the Kidney Foundation of Germany. DISCUSSION: The study is expected to answer the main research question by end 2005. There is however a high potential for various biases that we tried to address with adequate measure. One limitation however cannot be overcome: The methodologically needed age-limitation of the study will make it not easy to generalize the results to age groups over 50 years. It might be suggested to repeat the study for persons over 50 years in 10 years when contamination with phenacetin use early in life is likely to be outgrown

Breaking down automaticity: Case ambiguity and the shift to reflective approaches in clinical reasoning

Context: Two modes of case processing have been shown to underlie diagnostic judgements: analytical and non-analytical reasoning. An optimal form of clinical reasoning is suggested to combine both modes. Conditions leading doctors to shift from the usual mode of non-analytical reasoning to reflective reasoning have not been identified. This paper reports a study aimed at exploring these conditions by investigating the effects of ambiguity of clinical cases on clinical reasoning. Methods: Participants were 16 internal medicine residents in the Brazilian state of Ceará. They were asked to diagnose 20 clinical cases and recall case information. The independent variable was the degree of ambiguity of clinical cases, with 2 levels: straightforward (i.e. non-ambiguous) and ambiguous. Dependent variables were processing time, diagnostic accuracy and proposition per category recalled. Data were analysed using a repeated measures design. Results: Participants processed straightforward cases faster and more accurately than ambiguous ones. The proportion of text propositions recalled was significantly lower (t[15] = 2.29, P = 0.037) in ambiguous cases, and an interaction effect between case version and proposition category was also found (F[5, 75] = 4.52, P = 0.001, d = 0.232, observed power = 0.962). Furthermore, participants recalled significantly more literal propositions from the ambiguous cases than from the straightforward cases (t[15] = 2.28, P = 0.037). Conclusions: Ambiguity of clinical cases was shown to lead residents to switch from automatic to reflective reasoning, as indicated by longer processing time, and more literal propositions recalled in ambiguous cases

Outcome following surgery for colorectal cancer: analysis by hospital after adjustment for case-mix and deprivation

Outcome, adjusted for case-mix and deprivation, in 3200 patients undergoing resection for colorectal cancer in 11 hospitals in Central Scotland between 1991 and 1994 was studied. There were significant differences among individual hospitals in the proportion of elderly (P<0.001) and deprived (P<0.0001) patients, the mode (P=0.007) and stage (P<0.0001) at presentation, and the proportion of patients who underwent apparently curative resection (P<0.001). There were no significant differences in postoperative mortality. Cancer-specific survival at 5 years following apparently curative resection varied from 59 to 76%; cancer-specific survival at 2 years following palliative resection varied from 22 to 44%. The corresponding hazard ratios, adjusted for the above prognostic factors, for patients undergoing apparently curative resection varied among hospitals from 0.58 to 1.32; and the ratios for palliative resection varied from 0.73 to 1.26. This study demonstrates that, after adjustment for variations in case-mix and deprivation, significant differences in outcome among hospitals following resection for colorectal cancer persist

A survey of statistics in three UK general practice journal

Background Many medical specialities have reviewed the statistical content of their journals. To our knowledge this has not been done in general practice. Given the main role of a general practitioner as a diagnostician we thought it would be of interest to see whether the statistical methods reported reflect the diagnostic process. Methods Hand search of three UK journals of general practice namely the British Medical Journal (general practice section), British Journal of General Practice and Family Practice over a one-year period (1 January to 31 December 2000). Results A wide variety of statistical techniques were used. The most common methods included t-tests and Chi-squared tests. There were few articles reporting likelihood ratios and other useful diagnostic methods. There was evidence that the journals with the more thorough statistical review process reported a more complex and wider variety of statistical techniques. Conclusions The BMJ had a wider range and greater diversity of statistical methods than the other two journals. However, in all three journals there was a dearth of papers reflecting the diagnostic process. Across all three journals there were relatively few papers describing randomised controlled trials thus recognising the difficulty of implementing this design in general practice

The diagnosis of colorectal cancer in patients with symptoms: finding a needle in a haystack

Patients often see primary care physicians with symptoms that might signal colorectal cancer but are also common in adults without cancer. Physicians and patients must then make a difficult decision about whether and how aggressively to evaluate the symptom. Favoring referral is that missed diagnoses lead to unnecessary testing, prolonged uncertainty, and continuing symptoms; also, the physician will suffer chagrin. It is not clear that diagnostic delay leads to progression to a more advanced stage. Against referral is that proper evaluation includes colonoscopy, with attendant inconvenience, discomfort, cost, and risk. The article by Hamilton et al, published this month in BMC Medicine, provides strong estimates of the predictive value of the various symptoms and signs of colorectal cancer and show how much higher predictive values are with increasing age and male sex. Unfortunately, their results also make clear that most colorectal cancers present with symptoms with low predictive values, < 1.2%. Models that include a set of predictive variables, that is, risk factors, age, sex, screening history, and symptoms, have been developed to guide primary prevention and clinical decision-making and are more powerful than individual symptoms and signs alone. Although screening for colorectal cancer is increasing in many countries, cancers will still be found outside screening programs so primary care physicians will remain at the front line in the difficult task of distinguishing everyday symptoms from life-threatening cancer

Documentation of best interest by intensivists: a retrospective study in an Ontario critical care unit

<p>Abstract</p> <p>Background</p> <p>Intensive care physicians often must rely on substitute decision makers to address all dimensions of the construct of "best interest" for incapable, critically ill patients. This task involves identifying prior wishes and to facilitate the substitute decision maker's understanding of the incapable patient's condition and their likely response to treatment. We sought to determine how well such discussions are documented in a typical intensive care unit.</p> <p>Methods</p> <p>Using a quality of communication instrument developed from a literature search and expert opinion, 2 investigators transcribed and analyzed 260 handwritten communications for 105 critically ill patients who died in the intensive care unit between January and June 2006. Cohen's kappa was calculated before analysis and then disagreements were resolved by consensus. We report results on a per-patient basis to represent documented communication as a process leading up to the time of death in the ICU. We report frequencies and percentages for discrete data, median (m) and interquartile range (IQR) for continuous data.</p> <p>Results</p> <p>Our cohort was elderly (m 72, IQR 58-81 years) and had high APACHE II scores predictive of a high probability of death (m 28, IQR 23-36). Length of stay in the intensive care unit prior to death was short (m 2, IQR 1-5 days), and withdrawal of life support preceded death for more than half (n 57, 54%). Brain death criteria were present for 18 patients (17%). Although intensivists' communications were timely (median 17 h from admission to critical care), the person consenting on behalf of the incapable patient was explicitly documented for only 10% of patients. Life support strategies at the time of communication were noted in 45% of charts, and options for their future use were presented in 88%. Considerations relevant to determining the patient's best interest in relation to the treatment plan were not well documented. While explicit survival estimates were noted in 50% of charts, physicians infrequently documented their own predictions of the patient's functional status (20%), anticipated need for chronic care (0%), or post ICU quality of life (3%). Similarly, documentation of the patient's own perspectives on these ranged from 2-18%.</p> <p>Conclusions</p> <p>Intensivists' documentation of their communication with substitute decision makers frequently outlined the proposed plan of treatment, but often lacked evidence of discussion relevant to whether the treatment plan was expected to improve the patient's condition. Legislative standards for determination of best interest, such as the Health Care Consent Act in Ontario, Canada, may provide guidance for intensivists to optimally document the rationales for proposed treatment plans.</p

Inexperienced clinicians can extract pathoanatomic information from MRI narrative reports with high reproducibility for use in research/quality assurance

<p>Abstract</p> <p>Background</p> <p>Although reproducibility in reading MRI images amongst radiologists and clinicians has been studied previously, no studies have examined the reproducibility of inexperienced clinicians in extracting pathoanatomic information from magnetic resonance imaging (MRI) narrative reports and transforming that information into quantitative data. However, this process is frequently required in research and quality assurance contexts. The purpose of this study was to examine inter-rater reproducibility (agreement and reliability) among an inexperienced group of clinicians in extracting spinal pathoanatomic information from radiologist-generated MRI narrative reports.</p> <p>Methods</p> <p>Twenty MRI narrative reports were randomly extracted from an institutional database. A group of three physiotherapy students independently reviewed the reports and coded the presence of 14 common pathoanatomic findings using a categorical electronic coding matrix. Decision rules were developed after initial coding in an effort to resolve ambiguities in narrative reports. This process was repeated a further three times using separate samples of 20 MRI reports until no further ambiguities were identified (total n = 80). Reproducibility between trainee clinicians and two highly trained raters was examined in an arbitrary coding round, with agreement measured using percentage agreement and reliability measured using unweighted Kappa (<it>k</it>). Reproducibility was then examined in another group of three trainee clinicians who had not participated in the production of the decision rules, using another sample of 20 MRI reports.</p> <p>Results</p> <p>The mean percentage agreement for paired comparisons between the initial trainee clinicians improved over the four coding rounds (97.9-99.4%), although the greatest improvement was observed after the first introduction of coding rules. High inter-rater reproducibility was observed between trainee clinicians across 14 pathoanatomic categories over the four coding rounds (agreement range: 80.8-100%; reliability range <it>k </it>= 0.63-1.00). Concurrent validity was high in paired comparisons between trainee clinicians and highly trained raters (agreement 97.8-98.1%, reliability <it>k </it>= 0.83-0.91). Reproducibility was also high in the second sample of trainee clinicians (inter-rater agreement 96.7-100.0% and reliability <it>k </it>= 0.76-1.00; intra-rater agreement 94.3-100.0% and reliability <it>k </it>= 0.61-1.00).</p> <p>Conclusions</p> <p>A high level of radiological training is not required in order to transform MRI-derived pathoanatomic information from a narrative format to a quantitative format with high reproducibility for research or quality assurance purposes.</p

Evaluating priority setting success in healthcare: a pilot study

<p>Abstract</p> <p>Background</p> <p>In healthcare today, decisions are made in the face of serious resource constraints. Healthcare managers are struggling to provide high quality care, manage resources effectively, and meet changing patient needs. Healthcare managers who are constantly making difficult resource decisions desire a way to improve their priority setting processes. Despite the wealth of existing priority setting literature (for example, program budgeting and marginal analysis, accountability for reasonableness, the 'describe-evaluate-improve' strategy) there are still no tools to evaluate how healthcare resources are prioritised. This paper describes the development and piloting of a process to evaluate priority setting in health institutions. The evaluation process was designed to examine the procedural and substantive dimensions of priority setting using a multi-methods approach, including a staff survey, decision-maker interviews, and document analysis.</p> <p>Methods</p> <p>The evaluation process was piloted in a mid-size community hospital in Ontario, Canada while its leaders worked through their annual budgeting process. Both qualitative and quantitative methods were used to analyze the data.</p> <p>Results</p> <p>The evaluation process was both applicable to the context and it captured the budgeting process. In general, the pilot test provided support for our evaluation process and our definition of success, (i.e., our conceptual framework).</p> <p>Conclusions</p> <p>The purpose of the evaluation process is to provide a simple, practical way for an organization to better understand what it means to achieve success in its priority setting activities and identify areas for improvement. In order for the process to be used by healthcare managers today, modification and contextualization of the process are anticipated. As the evaluation process is applied in more health care organizations or applied repeatedly in an organization, it may become more streamlined.</p