Poul A. Pedersen

Randomised controlled trial of structured personal care of type 2 diabetes mellitus

Abstract Objective: To assess the effect of a multifaceted intervention directed at general practitioners on six year mortality, morbidity, and risk factors of patients with newly diagnosed type 2 diabetes. Design: Pragmatic, open, controlled trial with randomisation of practices to structured personal care or routine care; analysis after 6 years. Setting: 311 Danish practices with 474 general practitioners (243 in intervention group and 231 in comparison group). Participants: 874 (90.1%) of 970 patients aged ≥40 years who had diabetes diagnosed in 1989-91 and survived until six year follow up. Intervention: Regular follow up and individualised goal setting supported by prompting of doctors, clinical guidelines, feedback, and continuing medical education. Main outcome measures: Predefined clinical non-fatal outcomes, overall mortality, risk factors, and weight. Results: Predefined non-fatal outcomes and mortality were the same in both groups. The following risk factor levels were lower for intervention patients than for comparison patients (median values): fasting plasma glucose concentration (7.9 v 8.7 mmol/l, P=0.0007), glycated haemoglobin (8.5% v 9.0%, P<0.0001; reference range 5.4-7.4%), systolic blood pressure (145 v 150 mm Hg, P=0.0004), and cholesterol concentration (6.0 v 6.1 mmol/l, P=0.029, adjusted for baseline concentration). Both groups had lost weight since diagnosis (2.6 v 2.0 kg). Metformin was the only drug used more frequently in the intervention group (24% (110/459) v 15% (61/415)).Intervention doctors arranged more follow up consultations, referred fewer patients to diabetes clinics, and set more optimistic goals. Conclusions: In primary care, individualised goals with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that has been shown to reduce diabetic complications but without weight gain. What is already known on this topic Evidence is increasing that control of hyperglycaemia, hypertension, and dyslipidaemia may postpone the development of diabetic complications in patients with type 2 diabetes Maintaining good control over a long period can be difficult What this study adds Structured individualised personal care with educational and surveillance support for general practitioners reduced levels of risk factors in type 2 diabetic patients after six years Risk factors were reduced to a level that has been shown to have a beneficial effect on diabetic complications Participants also showed modest weight loss

Asthma and Allergic Rhinitis in the Same Patients

This study from Danish general practice gives Figures about the simultaneous prevalence of asthma and allergic rhinitis and the order of onset among 7662 patients, who during 1 year consulted for one or both of these diseases. Twenty‐eight percent of patients with asthma consulted because they also had allergic rhinitis, and 17% of patients with allergic rhinitis consulted because they also had asthma. Age‐ and sex‐distributions are presented. In 25% of patients with both diseases the onset of both diseases occurred within the same year, while in 35% the onset of asthma occurred first and in 40% allergic rhinitis.

Allergic Rhinitis in Danish General Practice.: Prevalence and Consultation Rates

The prevalence rate of allergic rhinitis and the consultation rate caused by this disease were studied in 131 general practices covering a population of 450,000 persons in Denmark. During a 1‐year period starting June 1977 all consultations with or without symptoms were recorded.

Month of Birth in Asthma and Allergic Rhinitis

The distribution by month of birth among 7796 patients, who consulted Danish general practitioners during a one year period 1977-78 because of asthma and/or allergic rhinitis is presented. Among allergic rhinitis patients births in March and April were significantly overrepresented, and July underrepresented. As a whole February-May were overrepresented and July-January underrepresented. The distribution of month of birth of asthma patients did not differ from the distribution of the total Danish population. Patients suffering from both asthma and allergic rhinitis presented a pattern similar to that of allergic rhinitis patients. Families with a high prevalence of allergy may take advantage of this knowledge when planning child births, as the findings may be explained partly by exposure to pollen during infancy.

Asthma in Danish General Practice.: Prevalence and Consultation Rates

This study from Danish general practice with the participation of 131 practices covering a population of 450, 000 persons assesses all consultations concerning asthma during a 1‐year period from June 1977.

Encouraging structured personalised diabetes care in general practice: A 6-year follow-up study of process and patient outcomes in newly diagnosed patients

Scand J Prim Health Care 2003;21:000-000. ISSN 0281-3432 Objective r - r To evaluate the quality of diabetes care achieved on the process and outcomes of care in the context of a multifaceted intervention directed at general practitioners (GPs) encouraging regular follow-up and individualised goal-setting. Design r - r A 6-year follow-up study. Setting r - r A total of 243 Danish GPs and a population-based sample of 729 newly diagnosed, predominantly type 2 diabetic patients participated. Main outcome measures r - r Questionnaires and laboratory assessments were used to determine the proportion of patients reviewed regularly, and their pharmacological treatment and risk factors. Results r - r During the study, the proportion of patients who had an annual clinical examination decreased from 100% to 77%. The proportion given oral anti-diabetic agents or insulin increased from 43% to 71%. Median glycated haemoglobin (HbA 1c ) dropped in the 2nd year to 7.7% (normal range 5.4-7.4%), after which it increased gradually, but remained on average at 1.3% above the upper limit of the normal range. Median blood pressure (systolic/diastolic), total cholesterols and fasting triglycerides were maintained at 145-150/81-85 mmHg, 6.0-6.2 mmol/l and 1.66-1.96 mmol/l, respectively. Initial weight loss was partly regained over 6 years. Conclusion r - r Among centrally supported GPs, most patients were regularly reviewed and obtained acceptable levels of risk factors for at least 6 years, although glycaemic control progressively deteriorated after an initial drop to near-normal average level.

Self-referral and self-payment in Danish primary care

This study aims at characterizing the group of people who want to have the right to consult any general practitioner or practising specialist without referral on condition of part self-payment, as opposed to the group of people who choose to be registered with a general practice that offers free services but controls further access to the health care system. All adults or a 10% sample of those listed in nationwide Danish registers were examined cross-sectionally for social and demographic factors and utilization of primary and secondary health care. A minority, which totals 3% of the population, chose free choice of doctor and part self-payment. On average, this group is older and has a higher income. Its mortality and its utilization of general practice and hospital services are lower, and its use of practising specialists is higher, than the majority. Among the persons who chose free choice and self-payment, the pattern of utilization is more likely to be due to a wish for free choice and for specialized medical care than to high morbidity. Dissatisfaction caused by restrictions on self-referral to specialists can be met by offering an option of a parallel system of free choice of doctor on condition of part self-payment.

The Effect of Dydrogesterone on Premenstrual Symptoms A Double-blind, Randomized, Placebo-controlled Study in General Practice

The effect of dydrogesterone on premenstrual symptoms was investigated in a double-blind, randomized, placebo-controlled study comprising 161 patients from unselected practice material. Dydrogesterone 10 mg twice daily from the 12th day until onset of the following menstrual period was compared with placebo throughout 3 cycles. No clinically relevant effect of dydrogesterone was found. There was an overall therapeutic effect in 52% of the patients on dydrogesterone, and in 44% of the placebo-treated patients. Therapeutic gain ranged between -7 and +23% (95% confidence limits). Type II error risk of failure to detect a therapeutic gain of 20% was 6%. A significant effect of dydrogesterone was found on decreased libido, and statistical significance was nearly achieved for the symptoms irritability and headache. The significant effect on libido can be attributed to mass significance.

Anaphylaxis to intravenous gentamicin with suspected sensitization through gentamicin-loaded bone cement.

Gentamicin is an aminoglycoside antibiotic used systemically for septicemia and as prophylaxis during surgery. In addition, gentamicin is widely used in bone cement for joint arthroplasty. Delayed type allergy (type IV) to gentamicin has been described and especially delayed type allergy to bone cement is attributed to gentamicin. However, immediate type allergy (type I) to gentamicin is rarely reported, and only 4 cases have been identified in the literature. We report thefifth case of anaphylaxis to intravenous gentamicin, which to our knowledge is the first case to suggest possible sensitization from previous exposure to gentamicin in bone cement. A 66-year-old woman was referred to the Danish Anesthesia Allergy Centre (DAAC) for investigation after anaphylaxis with cardiac arrest during elective laparoscopic cholecystectomy. The medical history included asthma, hypertension, and a left knee replacement 4 months previously, but no history of drug allergy. After anesthetic induction and 5 minutes after intravenous gentamicin, she developed severe hypotension (47/32 mm Hg), bradycardia (45 beats/minute), and desaturation (80%). She was treated with ephedrine, followed by epinephrine and atropine without any effect, and she went into asystole. After 10 minutes of cardiopulmonary resuscitation return of spontaneous circulation was attained. She developed generalized erythema and angioedema and was given antihistamines and steroids on suspicion of anaphylaxis. Surgery was canceled and she was transferred to intensive care where she remained intubated requiring norepinephrine infusion for 2 days. She suffered a cerebral infarction from which she totally recovered. Serum tryptase was markedly elevated at 138 mg/L 3 hours after the reaction. At allergy workup in DAAC, 2 months later she was tested with all drugs and substances she was exposed to before the reaction including latex, ethylene oxide, chlorhexidine, bupivacaine, dexamethasone, macrogols, remifentanil, cisatracurium, suxamethonium, propofol, and gentamicin (see Table E1 in this article’s Online Repository at www.jaci-inpractice.org). Baseline tryptase was 3.6 mg/L. In DAAC, serum tryptase is considered elevated at the time of reaction if the value exceeds 1.2 baseline value þ 2 mg/L. In our patient, this amounts to 6.32 mg/L, which means tryptase was elevated more than 20 times. Investigations comprise a combination of skin prick test (SPT), intradermal test (IDT), specific IgE, histamine release test (RefLab, Copenhagen, Denmark), and provocation. Titrated duplicate SPT with gentamicin up to undiluted concentration (40 mg/mL) was positive within 20 minutes showing clear dose response (see Table E2 in this article’s Online Repository at www.jaci-inpractice.org). Titrated duplicate IDT was clearly positive at a concentration of 0.4 mg/mL. Within minutes, the patient complained of itching on the shoulder and left knee, and wheals were present on the shoulder, and in the scar (Figure 1) from previous left knee replacement 4 months earlier. She developed no other symptoms and the hives resolved completely within 60 minutes with no treatment. The concentrations used for IDT (max 4 mg/mL) and SPT (max 40 mg/mL) tested negative in 29 exposed controls in our clinic, who all tolerated titrated intravenous provocation with gentamicin up to a maximum dose of 80 mg. The histamine release test for gentamicin later proved positive and all other substances tested negative in all other tests. Thus, she was diagnosed with immediate type allergy to gentamicin. See Tables E1 and E2 in this article’s Online Repository at www. jaci-inpractice.org. From previous notes we discovered that gentamicincontaining cement (PALACOS RþG cement) was used for her knee prosthesis. She recalled that her left leg had been swollen, red, and itchy postoperatively. Two weeks after surgery, she had been admitted to hospital on suspicion of deep venous thrombosis, which was not found on ultrasound, and infection was also ruled out. Because of unsatisfactory range of movement of the knee, 2 months after surgery, she underwent a manipulation of the joint under general anesthesia. She reported leaking of clear fluid from the middle of the scar for 3 months after surgery at the same location where the wheal developed during skin testing with gentamicin (Figure 1). Once the wound healed, she had no further problems. Eight months after allergy investigations in DAAC, she had an uneventful right knee replacement without gentamicin in the bone cement and without intravenous exposure. On detailed questioning, we could not identify other prior exposures to gentamicin or structurally related substances such as neomycin and consider it unlikely, as these drugs are rarely used in Denmark. We report a rare case of anaphylaxis to gentamicin. Although one earlier case report mentions that the patient had a hip prosthesis, no cases link previous exposure to bone cement with possible allergic sensitization to gentamicin and anaphylaxis on subsequent exposure. In our patient, intradermal testing with gentamicin elicited a localized reaction within minutes on the left knee, the site of suspected primary sensitization, separate from skin test sites on the forearm and back, where she also showed strongly positive immediate skin reactions. Previous exposure to gentamicin-loaded bone cement elicited allergic symptoms possibly due to primary allergic sensitization to gentamicin, as we cannot find evidence of earlier exposure. Alternatively, if she had been sensitized at a prior exposure, it might have been the first manifestation of an immediate type

The Central Research Unit of General Practice: A personal review after 22 years

The Central Research Unit of General Practice in Copenhagen was established in 1978 and was one of many steps in the progress of academic general practice that had been taken during the previous 40 years. The social development of the health care system in Denmark, with ever-greater specialization of medicine, had increasingly pointed to the risk of fragmented, episodic, disease-oriented, specialized patient care, and of an expensively organized health care system. This had led to an awareness of the need for the generalist practitioner, and within the general practice profession of a need for a deeper understanding of the role and tasks of the general practitioner (GP). Activities to promote teaching and research in general practice were gradually initiated within the profession.