The efficiency of a gatekeeping system for a health system, as in Germany, remains unclear particularly as access to specialist ambulatory care is not restricted. The aim was to compare the costs of coordinated versus uncoordinated patients (UP) in ambulatory care; with additional subgroup analysis of patients with mental disorders.
Retrospective routine data analysis of patients with statutory health insurance, using claims data held by the Bavarian Association of Statutory Health Insurance Physicians. A patient was defined as uncoordinated if he or she visited at least 1 specialist without a referral from a general practitioner within a quarter. Outcomes were compared with propensity score matching analysis.
The study encompassed all statutorily insured patients in Bavaria contacting at least 1 ambulatory specialist in the first quarter of 2011 (n=3 616 510).
Primary and secondary outcome measures
Primary outcome was total costs of ambulatory care; secondary outcomes were financial claims of general physicians, specialists and for medication.
The average age was 55.3 years for coordinated patients (CP, n=1 629 302), 48.3 years for UP (n=1 825 840). CP more frequently had chronic diseases (85.4%) as compared with UP (67.5%). The total unadjusted financial claim per patient was higher for UP (€234.52) than for CP (€224.41); the total adjusted difference was −€9.65 (95% CI −11.64 to −7.67), indicating lower costs for CP. The cost differences increased with increasing age. Total adjusted difference per patient with mental diseases as documented with an International Classification of Diseases (ICD)-10 F-diagnosis, was −€20.31 (95% CI −26.43 to −14.46).
Coordination of care is associated with lower ambulatory healthcare expenditures and is of particular importance for patients who are more vulnerable to medical interventions, especially for elderly and patients with mental disorders. The role of general practitioners as coordinators should be strengthened to improve care for these patients as this could also help to frame a more efficient health system.
access to care; health spending; PRIMARY CARE; organization and delivery of care
Academic infrastructures and networks for clinical research in primary care receive little funding in Germany. We aimed to provide an overview of the quantity, topics, methods and findings of randomised controlled trials published by German university departments of general practice.
We searched Scopus (last search done in April 2015), publication lists of institutes and references of included articles. We included randomised trials published between January 2000 and December 2014 with a first or last author affiliated with a German university department of general practice or family medicine. Risk of bias was assessed with the Cochrane tool, and study findings were quantified using standardised mean differences (SMDs).
Thirty-three trials met the inclusion criteria. Seventeen were cluster-randomised trials, with a majority investigating interventions aimed at improving processes compared with usual care. Sample sizes varied between 6 and 606 clusters and 168 and 7807 participants. The most frequent methodological problem was risk of selection bias due to recruitment of individuals after randomisation of clusters. Effects of interventions over usual care were mostly small (SMD <0.3). Sixteen trials randomising individual participants addressed a variety of treatment and educational interventions. Sample sizes varied between 20 and 1620 participants. The methodological quality of the trials was highly variable. Again, effects of experimental interventions over controls were mostly small.
Despite limited funding, German university institutes of general practice or family medicine are increasingly performing randomised trials. Cluster-randomised trials on practice improvement are a focus, but problems with allocation concealment are frequent.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-016-1328-y) contains supplementary material, which is available to authorized users.
Germany; Primary care; General practice; Randomised controlled trials; Academic performance
Preliminary findings suggest that Web-based interventions may be effective in achieving significant stress reduction. To date, there are no findings available for primary care patients. This is the first study that investigates a Web-based intervention for stress reduction in primary care.
The aim was to examine the short-term effectiveness of a fully automated Web-based coaching program regarding stress reduction in a primary care setting.
The study was an unblinded cluster randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily text message reminders, and weekly feedback through the Internet. All components of the program were fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was change in the Perceived Stress Questionnaire (PSQ) over 12 weeks.
A total of 93 participants (40 in intervention group, 53 in control group) were recruited into the study. For 25 participants from the intervention group and 49 participants from the control group, PSQ scores at baseline and 12 weeks were available. In the intention-to-treat analysis, the PSQ score decreased by mean 8.2 (SD 12.7) in the intervention group and by mean 12.6 (SD 14.7) in the control group. There was no significant difference identified between the groups (mean difference –4.5, 95% CI –10.2 to 1.3, P=.13).
This trial could not show that the tested Web-based intervention was effective for reducing stress compared to usual care. The limited statistical power and the high dropout rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed with larger populations to investigate the long-term outcome as well as the contents of usual primary care.
German Clinical Trials Register DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6eXk0PXmO)
Web-based; randomized controlled trial; life stress; stress reduction
To evaluate the influence of the practice setting on diagnostic accuracy of fractional exhaled nitric oxide (FENO) for diagnosing asthma; and to develop prediction rules for diagnostic decision-making including clinical signs and symptoms (CSS).
Patients from 10 general practices and 1 private practice of 5 pneumologists in ambulatory care.
553 patients, 57.9% female. Consecutive inclusion of diagnostic-naive patients suspected of suffering from obstructive airway disease. Exclusion criteria were respiratory tract infections within the last 6 weeks.
The index test was FENO measurement. Reference standard was the Tiffeneau ratio (forced expiratory volume in 1 s/vital capacity) or airway resistance as assessed by whole body plethysmography, with additional bronchoprovocation or bronchodilator testing.
Primary and secondary outcome measures
Asthma as determined by pneumologists, who were blind to FENO measurement results. Prediction rules were derived from multiple logistic regression analysis. A freely available calculator that allows computing all combinations was developed.
The practice setting only had minor influence on sensitivities of FENO cut-off points. In the final model (n=472), allergic rhinitis, wheezing and previous medication were positively associated with asthma. Increasing age and recurrent respiratory tract infections were negatively associated. The area under the curve (AUC) of FENO (AUC=0.650; 95% CI 0.599 to 0.701) increased significantly (p<0.0001) when combined with CSS (AUC=0.753; 95% CI 0.707 to 0.798). Presence of wheezing and allergic rhinitis allowed ruling in asthma with FENO >30 ppb. Ruling out with FENO <16 ppb in patients <43 years was only possible without allergic symptoms when recurrent respiratory tract infections were present.
FENO results should be interpreted in the context of CSS to enhance their diagnostic value in primary care. The final diagnostic model appears as a sound algorithm fitting well to the established diagnostic rules related to CSS of asthma. FENO appears more effective for ruling in asthma than for ruling it out.
PRIMARY CARE; sensitivity and specificity; diagnostic accuracy; nitric oxide
A variety of psychological interventions to treat depressive disorders have been developed and are used in primary care. In a systematic review, we compared the effectiveness of psychological treatments grouped by theoretical background, intensity of contact with the health care professional, and delivery mode for depressed patients in this setting.
Randomized trials comparing a psychological treatment with usual care, placebo, another psychological treatment, pharmacotherapy, or a combination treatment in adult depressed primary care patients were identified by database searches up to December 2013. We performed both conventional pairwise meta-analysis and network meta-analysis combining direct and indirect evidence. Outcome measures were response to treatment (primary outcome), remission of symptoms, post-treatment depression scores and study discontinuation.
A total of 37 studies with 7,024 patients met the inclusion criteria. Among the psychological treatments investigated in at least 150 patients face-to-face cognitive behavioral therapy (CBT; OR 1.80; 95 % credible interval 1.35–2.39), face-to-face counselling and psychoeducation (1.65; 1.27–2.13), remote therapist lead CBT (1.87; 1.38–2.53), guided self-help CBT (1.68; 1.22–2.30) and no/minimal contact CBT (1.53; 1.07–2.17) were superior to usual care or placebo, but not face-to-face problem-solving therapy and face-to-face interpersonal therapy. There were no statistical differences between psychological treatments apart from face-to-face interpersonal psychotherapy being inferior to remote therapist-lead CBT (0.60; 0.37–0.95). Remote therapist-led (0.86; 0.21–3.67), guided self-help (0.93; 0.62–1.41) and no/minimal contact CBT (0.85; 0.54–1.36) had similar effects as face-to-face CBT.
The limited available evidence precludes a sufficiently reliable assessment of the comparative effectiveness of psychological treatments in depressed primary care patients. Findings suggest that psychological interventions with a cognitive behavioral approach are promising, and primarily indirect evidence indicates that it applies also when they are delivered with a reduced number of therapist contacts or remotely.
Systematic review registration: 01KG1012 at http://www.gesundheitsforschung-bmbf.de/de/2852.php
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-015-0314-x) contains supplementary material, which is available to authorized users.
Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners.
Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting.
The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks.
We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080).
This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome.
German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).
smoking cessation; Web-based; randomized controlled trial; primary care
Diagnostic reasoning in primary care setting where presented problems and patients are mostly unselected appears as a complex process. The aim was to develop a questionnaire to describe how general practitioners (GPs) deal with uncertainty to gain more insight into the decisional process. The association of personality traits with medical decision making was investigated additionally.
Raw items were identified by literature research and focus group. Items were improved by interviewing ten GPs with thinking-aloud-method. A personal case vignette related to a complex and uncertainty situation was introduced. The final questionnaire was administered to 228 GPs in Germany. Factorial validity was calculated with explorative and confirmatory factor analysis. The results of the Communicating and Dealing with Uncertainty (CoDU) – questionnaire were compared with the scales of the ‘Physician Reaction to Uncertainty’ (PRU) questionnaire and with the personality traits which were determined with the Big Five Inventory (BFI-K).
The items could be assigned to four scales with varying internal consistency, namely ‘communicating uncertainty’ (Cronbach alpha 0.79), ‘diagnostic action’ (0.60), ‘intuition’ (0.39) and ‘extended social anamnesis’ (0.69). Neuroticism was positively associated with all PRU scales ‘anxiety due to uncertainty’ (Pearson correlation 0.487), ‘concerns about bad outcomes’ (0.488), ‘reluctance to disclose uncertainty to patients’ (0.287), ‘reluctance to disclose mistakes to physicians’ (0.212) and negatively associated with the CoDU scale ‘communicating uncertainty’ (−0.242) (p<0.01 for all). ‘Extraversion’ (0.146; p<0.05), ‘agreeableness’ (0.145, p<0.05), ‘conscientiousness’ (0.168, p<0.05) and ‘openness to experience’ (0.186, p<0.01) were significantly positively associated with ‘communicating uncertainty’. ‘Extraversion’ (0.162), ‘consciousness’ (0.158) and ‘openness to experience’ (0.155) were associated with ‘extended social anamnesis’ (p<0.05).
The questionnaire allowed describing the diagnostic decision making process of general practitioners in complex situations. Personality traits are associated with diagnostic reasoning and communication with patients, which might be important for medical education and quality improvement purposes.
We aimed to investigate the use of placebos (e.g. saline injections) and non-specific treatments (e.g. vitamin supplements in individuals without a relevant deficiency) among physicians working in private practices in Germany, and how such use is associated with the belief in and the use of complementary and alternative treatments, and basic professional attitudes. A four-page questionnaire was sent to nationwide random samples of general practitioners (GP), internists and orthopaedists working in private practices. The response rate was 46% (935 of 2018). 24% of GPs, 44% of internists and 57% of orthopaedists had neither used pure placebos nor non-specific therapies in the previous 12 months. 11% percent of GPs, 12% of internists and 7% of orthopaedists had exclusively used pure placebos; 30%, 33% and 26%, respectively, had exclusively used non-specific therapies; 35%, 12% and 9% had used both. Age, sex and agreement to the statement that physicians should harness placebo effects were not significantly associated with any pattern of use. Exclusive use of pure placebos was associated with being a GP, being an internist, and having unorthodox professional views. In addition to these three factors, a lower use of CAM therapies and a wish for having more time was associated with the exclusive use of non-specific therapies. Among physicians using both pure placebo and non-specific therapies, heterodox views were also somewhat more pronounced. However, associations were particularly strong for being a GP (Odds ratio 11.6 (95%CI 6.41; 21.3)) and having orthodox views (Odds ratio 0.10 (95%CI 0.06; 0.18)) among this group. In conclusion, the use of placebos and non-specific treatments varies strongly between medical specialties and is associated with basic professional attitudes. The findings support the view that the use of placebos and, in particular, of non-specific therapies is primarily a coping behaviour for difficult and uncertain situations.
Students in German medical schools frequently complain that the subject ‘clinical examination’ is not taught in a satisfying manner due to time constraints and lack of personnel resources. While the effectiveness and efficiency of practice-oriented teaching in small groups using near-peer teaching has been shown, it is rarely used in German medical schools. We investigated whether adding a new near-peer teaching course developed with student input plus patient examination under supervision in small groups improves basic clinical examination skills in third year medical students compared to a traditional clinical examination course alone.
Third year medical students registered for the mandatory curricular clinical examination course at the medical faculty of the Technische Universität München were invited to participate in a randomised trial with blinded outcome assessment. Students were randomised to the control group participating in the established curricular physical examination course or to the intervention group, which received additional near-peer teaching for the same content. The learning success was verified by a voluntary objective structured clinical examination (OSCE).
A total of 84 students were randomised and 53 (63%) participated in the final OSCE. Students in the control group scored a median of 57% (25th percentile 47%, 75th percentile 61%) of the maximum possible total points of the OSCE compared to 77% (73%, 80%; p < 0.001) for students in the intervention group. Only two students in the intervention group received a lower score than the best student in the control group.
Adding a near-peer teaching course to the routine course significantly improved the clinical examination skills of medical students in an efficient manner in the context of a resource-constrained setting.
Objective: Germany is witnessing an increasing shortage of general practitioners (GPs). The aim was to determine predictors of the job-related motivation of medical students of three medical faculties with different institutionalisation of general practice as an academic discipline.
Methods: Medical students were surveyed with a standardised questionnaire about their attitudes towards general practice and their motivation to work as a GP in different working conditions. Predictors for positive attitudes and motivation were calculated using logistic regression models.
Results: 940 (15.2%) out of 6182 medical students from three Bavarian medical faculties participated in an online survey. 585 (62.7%) were female, and the average age was 25.0 (standard deviation 3.7). The average grade of a university-entrance diploma was 1.6 (standard deviation 0.5). 718 (76.4%) could imagine working as a GP. However, they favoured being employed within another organisation and not having their own private practice (65.5% vs. 35.1%). “Presence of a professorship of general practice” was associated with a positive attitude towards general practice (OR 1.57; 95%CI 1.13-2.417). Motivation for working as a GP was associated with “being female” (OR 2.56; 95%CI 1.80-3.56) and “presence of a professorship of general practice” (OR 1.68; 95%CI 1.14-2.46). Having a lower grade for one’s university-entrance diploma was associated with a higher preference to work in one’s own practice (OR 1.39; 95%CI 1.02-1.90).
Conclusion: A high amount of medical students were open-minded towards general practice. However, they favoured employment within an organization over working in their own practice. Institutionalisation of general practice as an academic discipline might be of importance to gain positive attitudes towards general practice and motivate medical students to work as a GP.
general practice; institutionalisation; medical students; medical profession; motivation
In elderly patients chronic kidney disease often limits drug prescription. As several equations for quick assessment of kidney function by estimating glomerular filtration rate (eGFR) and several different clinical recommendations for drug dose adjustment in renal failure are published, choosing the correct approach for drug dosage is difficult for the practitioner. The aims of our study were to quantify the agreement between eGFR-equations grouped by creatinine-based or cystatin C-based and within the groups of creatinine and cystatin C-based equations and to investigate whether use of various literature and online references results in different recommendations for drug dose adjustment in renal disease in very elderly primary care patients.
We included 108 primary care patients aged 80 years and older from 11 family practices into a cross-sectional study. GFR was estimated using two serum creatinine-based equations (Cockroft-Gault, MDRD) and three serum cystatin C-based equations (Grubb, Hoek, Perkins). Concordance between different equations was quantified using intraclass correlation coefficients (ICCs). Essential changes in drug doses or discontinuation of medication were documented and compared in terms of estimated renal function as a consequence of the different eGFR-equations using five references commonly used in the US, Great Britain and Germany.
In general, creatinine-based equations resulted in lower eGFR-estimation and in higher necessity of drug dose adjustment than cystatin C-based equations. Concordance was high between creatinine-based equations alone (ICCs 0.87) and between cystatin C-based equations alone (ICCs 0.90 to 0.96), and moderate between creatinine-based equations and cystatin C-based equations (ICCs 0.54 to 0.76). When comparing the five different references consulted to identify necessary drug dose adjustments we found that the numbers of drugs that necessitate dose adjustment in the case of renal impairment differed considerably. The mean number of recommended changes in drug dosage ranged between 1.9 and 2.5 per patient depending on the chosen literature reference.
Our data suggest that the choice of the literature source might have even greater impact on drug management than the choice of the equation used to estimate GFR alone. Efforts should be deployed to standardize methods for estimating kidney function in geriatric patients and literature recommendations on drug dose adjustment in renal failure.
Estimated kidney function; Aged 80 years and older; Drug dose adjustment; Primary care; Literature references
Preliminary findings suggest that web-based interventions may be effective in achieving significant weight loss and weight loss maintenance. To date only few findings within primary care patients and especially the involvement of general practitioners are available. The aim of this trial was to examine the short-term effectiveness of a web-based coaching program in combination with an accompanied telephone counselling regarding weight reduction in a primary care setting.
The study was a cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a web-based coaching program based on education, motivation, exercise guidance, daily SMS reminding, weekly feedback through internet and active monitoring by general practitioners. Participants in the control group received usual care and advice from their practitioner without the web-based coaching program. The main outcome was weight change between admission and after 12 weeks.
186 participants (109 intervention group, 77 control group) were recruited into study. For 76 participants from the intervention group and 72 participants from the control group weight measurements were available both at baseline and 12 weeks. Weight decreased on average by 4.2 kg in the intervention group and 1.7 kg in the control group (mean group difference 2.5 kg; 95%CI 1,1; 3,8; p < 0.001). Reductions for waist circumference and BMI were also significantly larger within intervention.
Findings of the present trial suggest that the tested web-based coaching program for weight loss is effective in short-term. Further RCT’s are desirable in order to confirm present findings in larger populations and to investigate long-term outcomes.
German Register for Clinical Trials: DRKS00003067
Overweight; Obesity; Weight loss; Web-based; Randomized controlled trial
Governmental funding support is seen as a prerequisite for the growth of research in general practice. Several funding programs in the amount of € 13.2 Mio were introduced in Germany from 2002 to February 2012. We aim to provide an overview of publications reporting original data and systematic reviews from German academic family medicine published between 2000 and 2010.
Publications were identified by searching the database Scopus and screening publication lists of family medicine divisions or institutes. Papers had to report original primary research studies or systematic reviews; at least one of the authors had to be affiliated to a German academic family medicine division or institute.
794 articles were included. The number of publications increased steadily starting from 107 in the period from 2000 to 2003, to 273 from 2004 to 2007, and finally to 414 from 2008 to 2010. Less than 25% were published in English in the first period. This proportion increased to 60.6% from 2008 to 2010. Articles published in a journal without impact factor decreased from 59.8% to 31.9%. Nevertheless, even in the most recent period only 31.6% of all articles were published in a journal with an impact factor above 2. The median impact factor increased from 0 in the first period to 1.2 in the last.
The output of original research publications from academic research divisions and institutes for general practice in Germany greatly increased during the last decade. However, professionalism of German primary care research still needs to be developed.
Research articles; Germany; Primary care; General practice; Academic performance
Several systematic reviews have summarized the evidence for specific treatments of primary care patients suffering from depression. However, it is not possible to answer the question how the available treatment options compare with each other as review methods differ. We aim to systematically review and compare the available evidence for the effectiveness of pharmacological, psychological, and combined treatments for patients with depressive disorders in primary care.
To be included, studies have to be randomized trials comparing antidepressant medication (tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), hypericum extracts, other agents) and/or psychological therapies (e.g. interpersonal psychotherapy, cognitive therapy, behavioural therapy, short dynamically-oriented psychotherapy) with another active therapy, placebo or sham intervention, routine care or no treatment in primary care patients in the acute phase of a depressive episode. Main outcome measure is response after completion of acute phase treatment. Eligible studies will be identified from available systematic reviews, from searches in electronic databases (Medline, Embase and Central), trial registers, and citation tracking. Two reviewers will independently extract study data and assess the risk of bias using the Cochrane Collaboration's corresponding tool. Meta-analyses (random effects model, inverse variance weighting) will be performed for direct comparisons of single interventions and for groups of similar interventions (e.g. SSRIs vs. tricyclics) and defined time-windows (up to 3 months and above). If possible, a global analysis of the relative effectiveness of treatments will be estimated from all available direct and indirect evidence that is present in a network of treatments and comparisons.
Practitioners do not only want to know whether there is evidence that a specific treatment is more effective than placebo, but also how the treatment options compare to each other. Therefore, we believe that a multiple treatment systematic review of primary-care based randomized controlled trials on the most important therapies against depression is timely.
The effect of psychosomatic co-morbidity on resource use for systems with unlimited access remains unclear. The aim of this study was to evaluate the impact on practice visits, referrals and periods of disability in German general practices and to identify predictors of health care utilisation.
Cross sectional observational study in 13 practices in Upper Bavaria. Patients were included consecutively and filled in the Patients Health Questionnaire (PHQ). Numbers of practice visits, referrals and periods of disability within the last twelve months and permanent mental and somatic diagnoses were extracted manually by review of the computerised charts. Physicians in Germany are obliged to document repetitive reasons of encounter as permanent diagnoses in terms of ICD-10-codes. These ICD-10-codes are used for legitimisation of reimbursement in German general practices.
1005 patients were included (58.6% female). On average, patients had 15.3 (sd 16.3) practice contacts, 3.8 (sd 4.2) referrals and 7.5 (sd 23.1) days of disability per year. The mean number of coded permanent diagnoses was 0.4 (sd 0.7) for mental and 4.0 (sd 4.0) for somatic diagnoses. Patients with mental diagnoses scored higher in depression, anxiety, panic and somatoform disorder scales of PHQ. Frequent practice visits were associated stronger with coded permanent mental diagnoses (OR 20.0; 95%CI 7.5-53.9) than with coded permanent somatic diagnoses (OR 14.4; 95%CI 5.9-35.4). Frequent referrals were associated stronger with somatic diagnoses (OR 4.9; 95%CI 2.0-11.9) than with mental diagnoses (OR 3.6; 95%CI 1.4-9.8). Periods of disability were predicted by mental diagnoses (OR 5.0; 95%CI 1.6-15.8) but not by somatic diagnoses (OR 2.5; 95%CI 0.7-8.1).
Psychosomatic co-morbidity has a stronger impact on health care utilisation in German general practices with respect to practice visits and periods of disability whereas somatic disorders play a stronger role for referrals. Time constraints in the practices might lead to frequent contacts as too little time is left for patients with mental problems. Therefore, structural changes in the health care reimbursement systems might be necessary. Mental diagnoses might be helpful to identify patients at risk for high health care utilisation. However, the use of routinely coded diagnoses for reimbursement might lead to distorted estimation of resource use.
Prevention of falls in the elderly is a public health target in many countries around the world. While a large number of trials have investigated the effectiveness of fall prevention programs, few focussed on interventions embedded in the general practice setting and its related network. In the Prevent Falls (PreFalls) trial we aim to investigate the effectiveness of a pre-tested multi-modal intervention compared to usual care in this setting.
PreFalls is a controlled multicenter prospective study with cluster-randomized allocation of about 40 general practices to an experimental or a control group. We aim to include 382 community dwelling persons aged 65 and older with an increased risk of falling. All participating general practitioners are trained to systematically assess the risk of falls using a set of validated tests. Patients from intervention practices are invited to participate in a 16-weeks exercise program with focus on fall prevention delivered by specifically trained local physiotherapists. Patients from practices allocated to the control group receive usual care. Main outcome measure is the number of falls per individual in the first 12 months (analysis by negative binomial regression). Secondary outcomes include falls in the second year, the proportion of participants falling in the first and the second year, falls associated with injury, risk of falls, fear of falling, physical activity and quality of life.
Reducing falls in the elderly remains a major challenge. We believe that with its strong focus on a both systematic and realistic fall prevention strategy adapted to primary care setting PreFalls will be a valuable addition to the scientific literature in the field.
While several recent large randomized trials found clinically relevant effects of acupuncture over no treatment or routine care, blinded trials comparing acupuncture to sham interventions often reported only minor or no differences. This raises the question whether (sham) acupuncture is associated with particularly potent nonspecific effects. We aimed to investigate the size of nonspecific effects associated with acupuncture interventions.
MEDLINE, Embase, Cochrane Central Register of Controlled Clinical Trials and reference lists were searched up to April 2010 to identify randomized trials of acupuncture for any condition, including both sham and no acupuncture control groups. Data were extracted by one reviewer and verified by a second. Pooled standardized mean differences were calculated using a random effects model with the inverse variance method.
Thirty-seven trials with a total of 5754 patients met the inclusion criteria. The included studies varied strongly regarding patients, interventions, outcome measures, methodological quality and effect sizes reported. Among the 32 trials reporting a continuous outcome measure, the random effects standardized mean difference between sham acupuncture and no acupuncture groups was -0.45 (95% confidence interval, -0.57, -0.34; I2 = 54%; Egger's test for funnel plot asymmetry, P = 0.25). Trials with larger effects of sham over no acupuncture reported smaller effects of acupuncture over sham intervention than trials with smaller nonspecific effects (β = -0.39, P = 0.029).
Sham acupuncture interventions are often associated with moderately large nonspecific effects which could make it difficult to detect small additional specific effects. Compared to inert placebo interventions, effects associated with sham acupuncture might be larger, which would have considerable implications for the design and interpretation of clinical trials.
The use of placebo interventions outside clinical trials is ethically, professionally and legally controversial. Little is known about the frequency and circumstances of placebo use in clinical practice. Our aim was to summarize the available empirical studies addressing these issues.
We searched PubMed and EMBASE from inception to July 2009 in order to identify cross-sectional surveys, qualitative or longitudinal studies among health care professionals, students or patients which investigated at least one of the following issues - frequency of placebo use or attitudes to, or motivations for, the use of placebo interventions. At least two reviewers extracted information on the study methods, participants and findings. Descriptive summaries were prepared in an iterative process by at least two reviewers per study.
Twenty-two studies from 12 different countries met the inclusion criteria. Most studies had relevant shortcomings. The proportion of respondents reporting that they had applied 'pure' placebos (for example, saline injection) during their professional life varied between 17% and 80% among physicians and between 51% and 100% among nurses, but it seems that the actual frequency of such use seems to be rare. The use of 'impure' or 'active' placebos (for example, antibiotics for viral infections) is likely to be much more frequent. However, it is impossible to make a reliable estimation because there is no agreement of what an impure placebo might be. Studies using qualitative methods or asking participants to judge case examples suggest that motivations and attitudes towards placebo use are complex and health care providers are often faced with a dilemma.
Although the available evidence is incomplete and confusing at times there can be little doubt that the prevalence of placebo use outside of clinical trials is not negligible and that views and attitudes on placebos use differ considerably among individuals, both health care professionals and patients. Further research is needed to clarify these issues.
To evaluate the sensitivity, specificity and predictive values of spirometry for the diagnosis of chronic obstructive pulmonary disease (COPD) and asthma in patients suspected of suffering from an obstructive airway disease (OAD) in primary care.
Cross sectional diagnostic study of 219 adult patients attending 10 general practices for the first time with complaints suspicious for OAD. All patients underwent spirometry and structured medical histories were documented. All patients received whole-body plethysmography (WBP) in a lung function laboratory. The reference standard was the Tiffeneau ratio (FEV1/VC) received by the spirometric maneuver during examination with WBP. In the event of inconclusive results, bronchial provocation was performed to determine bronchial hyper-responsiveness (BHR). Asthma was defined as a PC20 fall after inhaling methacholine concentration ≤ 16 mg/ml.
90 (41.1%) patients suffered from asthma, 50 (22.8%) suffered from COPD, 79 (36.1%) had no OAD. The sensitivity for diagnosing airway obstruction in COPD was 92% (95%CI 80–97); specificity was 84% (95%CI 77–89). The positive predictive value (PPV) was 63% (95%CI 51–73); negative predictive value (NPV) was 97% (95%CI 93–99). The sensitivity for diagnosing airway obstruction in asthma was 29% (95%CI 21–39); specificity was 90% (95%CI 81–95). PPV was 77% (95%CI 60–88); NPV was 53% (95%CI 45–61).
COPD can be estimated with high diagnostic accuracy using spirometry. It is also possible to rule in asthma with spirometry. However, asthma can not be ruled out only using spirometry. This diagnostic uncertainty leads to an overestimation of asthma presence. Patients with inconclusive spirometric results should be referred for nitric oxide (NO) – measurement and/or bronchial provocation if possible to guarantee accurate diagnosis.
To evaluate the sensitivity, specificity and predictive values of fractional exhaled nitric oxide (FENO) for the diagnosis of asthma in general practice.
Prospective diagnostic study with 160 patients attending 10 general practices for the first time with complaints suspicious of obstructive airway disease (OAD). Patients were referred to a lung function laboratory for diagnostic investigation. The index test was FENO measured with a portable FENO analyser based on electrochemical sensor. The reference standard was the Tiffeneau ratio (FEV1/VC) as received by spirometric manoeuvre and/or results of bronchial provocation. Bronchial provocation with methacholine was performed to determine bronchial hyper-responsiveness (BHR) in the event of inconclusive spirometric results.
88 (55%) were female; their average age was 43.9 years. 75 (46.9%) patients had asthma, 25 (15.6%) had COPD, 8 (5.0%) had an overlap of COPD and asthma, and 52 (32.5%) had no OAD. At a cut-off level of 46 parts per billion (ppb) (n = 30; 18.8%), sensitivity was 32% (95%CI 23–43%), specificity 93% (95%CI 85–97%), positive predictive value (PPV) 80% (95%CI 63–91%), negative predictive value (NPV) 61% (95%CI 52–69%) when compared with a 20% fall in FEV1 from the baseline value (PC20) after inhaling methacholine concentration ≤ 16 mg/ml. At 76 ppb (n = 11; 6.9%) specificity was 100% (95%CI 96–100%) and PPV was 100% (95%CI 72–100). At a cut-off level of 12 ppb (n = 34; 21.3%), sensitivity was 90% (95%CI 79–95%), specificity 25% (95%CI 17–34%), PPV 40% (95%CI 32–50), NPV 81% (95%CI 64–91%) when compared with a 20% fall of FEV1 after inhaling methacholine concentration ≤ 4 mg/ml. Three patients with unsuspicious spirometric results have to be tested with FENO to save one bronchial provocation test.
Asthma could be ruled in with FENO > 46 ppb. Mild and moderate to severe asthma could be ruled out with FENO ≤ 12 ppb. FENO measurement with an electrochemical sensor might be reasonable with respect to the time consuming procedure of bronchial provocation, which carries also some risk of severe bronchospasm. Further research is necessary to evaluate the effectiveness of this dual diagnostic strategy. The number needed to diagnose might be improved when the diagnostic precision could be enhanced by future technical developments.
Rationale and aims
Quality circles (QCs) are well established as a means of aiding doctors. New quality improvement strategies include benchmarking activities. The aim of this paper was to evaluate the efficacy of QCs for asthma care working either with general feedback or with an open benchmark.
Twelve QCs, involving 96 general practitioners, were organized in a randomized controlled trial. Six worked with traditional anonymous feedback and six with an open benchmark; both had guided discussion from a trained moderator. Forty-three primary care practices agreed to give out questionnaires to patients to evaluate the efficacy of QCs.
A total of 256 patients participated in the survey, of whom 185 (72.3%) responded to the follow-up 1 year later. Use of inhaled steroids at baseline was high (69%) and self-management low (asthma education 27%, individual emergency plan 8%, and peak flow meter at home 21%). Guideline adherence in drug treatment increased (P = 0.19), and asthma steps improved (P = 0.02). Delivery of individual emergency plans increased (P = 0.008), and unscheduled emergency visits decreased (P = 0.064). There was no change in asthma education and peak flow meter usage. High medication guideline adherence was associated with reduced emergency visits (OR 0.24; 95% CI 0.07–0.89). Use of theophylline was associated with hospitalization (OR 7.1; 95% CI 1.5–34.3) and emergency visits (OR 4.9; 95% CI 1.6–14.7). There was no difference between traditional and benchmarking QCs.
Quality circles working with individualized feedback are effective at improving asthma care. The trial may have been underpowered to detect specific benchmarking effects. Further research is necessary to evaluate strategies for improving the self-management of asthma patients.
asthma; emergency visit; general practice; hospitalization; quality circle; self-management
The purpose of this work was to assess the evidence for effectiveness of acupuncture (AC) treatment in gastrointestinal diseases. A systematic review of the Medline-cited literature for clinical trials was performed up to May 2006. Controlled trials assessing acupuncture point stimulation for patients with gastrointestinal diseases were considered for inclusion. The search identified 18 relevant trials meeting the inclusion criteria. Two irritable bowel syndrome (IBS) trials, 1 Crohn's disease and 1 colitis ulcerosa trial had a robust random controlled trial (RCT) design. In regard to other gastrointestinal disorders, study quality was poor. In all trials, quality of life (QoL) improved significantly independently from the kind of acupuncture, real or sham. Real AC was significantly superior to sham acupuncture with regard to disease activity scores in the Crohn and Colitis trials. Efficacy of acupuncture related to QoL in IBS may be explained by unspecific effects. This is the same for QoL in inflammatory bowel diseases (IBD), whereas specific acupuncture effects may be found in clinical scores. Further trials for IBDs and in particular for all other gastrointestinal disorders would be necessary to evaluate the efficacy of acupuncture treatment. However, it must be discussed on what terms patients benefit when this harmless and obviously powerful therapy with regard to QoL is demystified by further placebo controlled trials.
Irritable bowel syndrome; Inflammatory bowel disease; Gastrointestinal disease; Placebo; Acupuncture
The aim of the study was to examine the validity of a translated and culturally adapted version of the Physicians' Reaction to Uncertainty scales (PRU) in primary care physicians.
In a structured process, the original questionnaire was translated, culturally adapted and assessed after administering it to 93 GPs. Test-retest reliability was tested by sending the questionnaire to the GPs again after two weeks.
The principal factor analysis confirmed the postulated four-factor structure underlying the 15 items. In contrast to the original version, item 5 achieved a higher loading on the 'concern about bad outcomes' scale. Consequently, we rearranged the scales. Good item-scale correlations were obtained, with Pearson's correlation coefficient ranging from 0.56–0.84. As regards the item-discriminant validity between the scales 'anxiety due to uncertainty' and 'concern about bad outcomes', partially high correlations (Pearson's correlation coefficient 0.02–0.69; p < 0.001) were found, indicating an overlap between both constructs. The assessment of internal consistency revealed satisfactory values; Cronbach's alpha of the rearranged version was 0.86 or higher for all scales. Test-retest-reliability, assessed by means of the intraclass-correlation-coefficient (ICC), exceeded 0.84, except for the 'reluctance to disclose mistakes to physicians' scale (ICC = 0.66). In this scale, some substantial floor effects occurred, with 29.3% of answers showing the lowest possible value.
Dealing with uncertainty is an important issue in daily practice. The psychometric properties of the rearranged German version of the PRU are satisfying. The revealed floor effects do not limit the significance of the questionnaire. Thus, the German version of the PRU could contribute to the further evaluation of the impact of uncertainty in primary care physicians.
To evaluate the diagnostic accuracy of clinical signs and symptoms, C-reactive protein (CRP) and spirometric parameters and determine their interrelation in patients suspected to have an obstructive airway disease (OAD) in primary care.
In a cross sectional diagnostic study, 60 adult patients coming to the general practitioner (GP) for the first-time with complaints suspicious for obstructive airway disease (OAD) underwent spirometry. Peak expiratory flow (PEF)-variability within two weeks was determined in patients with inconspicuous spirometry. Structured medical histories were documented and CRP was measured. The reference standard was the Tiffeneau ratio (FEV1/VC) in spirometry and the PEF-variability. OAD was diagnosed when FEV1/VC ≤ 70% or PEF-variability > 20%.
37 (62%) patients had OAD. The best cut-off value for CRP was found at 2 mg/l with a diagnostic odds ratio (OR) of 4.4 (95% CI 1.4–13.8). Self-reported wheezing was significantly related with OAD (OR 3.4; CI 1.1–10.3), whereas coughing was inversely related (OR 0.2; CI 0.1–0.7). The diagnostic OR of CRP increased when combined with dyspnea (OR 8.5; 95% CI 1.7–42.3) or smoking history (OR 8.4; 95% CI 1.5–48.9). CRP (p = 0.004), FEV1 (p = 0.001) and FIV1 (p = 0.023) were related with the severity of dyspnea. CRP increased with the number of cigarettes, expressed in pack years (p = 0.001).
The diagnostic accuracy of clinical signs and symptoms was low. The diagnostic accuracy of CRP improved in combination with dyspnea and smoking history. Due to their coherence with the severity of dyspnea and number of cigarettes respectively, CRP and spirometry might allow risk stratification of patients with OAD in primary care. Further studies need to be done to confirm these findings.