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Biomedical subjects

Marjukka Mäkelä

Publications and source records attributed to Marjukka Mäkelä.

At least 19 recordsLinked to original sources

A systematic review finds that methodological quality is better than its reputation but can be improved in physiotherapy trials in childhood cerebral palsy.

OBJECTIVES: To identify critical issues in performing randomized controlled trials (RCTs) on complex interventions such as physiotherapy in multifaceted disabilities like cerebral palsy (CP); to systematically assess how well trials handled patient characteristics, key components of complex interventions, and outcome assessments; to make suggestions for improving the effectiveness of physiotherapy research. DESIGN AND METHODS: A methodological review. An ongoing metareview served as sampling frame. RCTs on physiotherapy in children with CP published after 1990 were eligible. The main outcome measures were sampling, recruitment, and comparability of groups; defined components of a complex intervention; outcome measures according to the World Health Organization International Classification of Functioning and clinical interpretation of score change. RESULTS: Fifty-seven clinical trials were identified, of which 14 RCTs were included. Most studies used simple randomization, complemented by balancing techniques such as matching or stratification. Only three of 14 studies specified concealed allocation. Numerous studies provided sufficient details on components of a complex intervention (e.g., 'standardized intervention' (12/14); 'the active therapeutic ingredient' (8/15). Overlap of instruments across studies was poor, only instruments on activity endpoints were more homogeneous. The clinical interpretation of observed score changes was mostly missing. CONCLUSION: We found good to fair methodological quality in a considerable number of RCTs on physiotherapy in CP children. Nevertheless, improvement is indicated for certain areas in design and performance of future studies. This review shows that informative RCTs on complex interventions for multifaceted disabilities are feasible.

Cerebral Palsy↗

Overview of systematic reviews on invasive treatment of stable coronary artery disease.

OBJECTIVES: The aim of the study was to evaluate the validity of the systematic reviews as a source of best evidence and to present and interpret the evidence of the systematic reviews on effectiveness of surgery and percutaneous interventions for stable coronary artery disease. METHODS: Electronic databases were searched without language restriction from January 1966 to March 2004. The databases used included the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, DARE, the Health Technology Assessment Database, MEDLINE(R), MEDLINE(R) In-Process & Other Non-Indexed Citations. We included systematic reviews of randomized clinical trials on patients with stable coronary heart disease undergoing percutaneous coronary intervention or coronary artery bypass surgery in comparison with medical treatment or a comparison between invasive techniques. At least one of the following outcomes had to be reported: death, myocardial infarction, angina pectoris, revascularization. The methodological quality was assessed using a modified version of the scale devised by Oxman and Guyatt (1991). A standardized data-extraction form was used. The method used to evaluate clinical relevance was carried out with updated method guidelines from the Cochrane Back Research Group. Quantitative synthesis of the effectiveness data is presented. RESULTS: We found nineteen systematic reviews. The median score of validity was 13 points (range, 6-17 points), with a maximum of 18 points. Coronary artery bypass surgery gives better relief of angina, and the need for repeated procedures is reduced after bypass surgery compared with percutaneous interventions. There is inconsistent evidence as to whether bypass surgery improves survival compared with percutaneous intervention. A smaller need for repeated procedures exists after bare metal stent and even more so after drug-eluting stent placement than after percutaneous intervention without stent placement. However, according to the current evidence, these treatment alternatives do not differ in terms of mortality or myocardial infarction. CONCLUSIONS: We found some high-quality systematic reviews. There was evidence on the potential of invasive treatments to provide symptomatic relief. Surgery seems to provide a longer-lasting effect than percutaneous interventions with bare metal stents or without stents. Evidence in favor of drug-eluting stents so far is based on short-term follow-up and mostly on patients with single-vessel disease.

Angioplasty, Balloon, Coronary↗

Cost-effectiveness of implementing national guidelines in the treatment of acute otitis media in children.

OBJECTIVES: Acute otitis media (AOM) is one of the most common diseases of childhood, representing a major disease burden on the society. New evidence-based guidelines for AOM, focusing on children under 7 years of age, were introduced in Finland in 1999. The aim of this study was to evaluate the cost-effectiveness of implementing those guidelines in Finland. METHODS: A 5-year prospective trial was conducted in thirty community primary healthcare centers in Finland. All AOM patients between 0 and 6 years of age visiting the study health centers for the first time, for this episode of illness, during 1 week in November 1998 (n = 579) and November 2002 (n = 369) were included in this study. The outcome measure was the percentage of symptom-free patients. RESULTS: The mean direct cost of an AOM episode per patient stayed almost the same after implementing the guidelines, euro152 in 1998 and euro150 in 2002. After implementing the guidelines, the percentage of symptom-free patients was 10 percentage points higher than before the guidelines. The treatment after the implementation of the guidelines, thus, was a dominant strategy. CONCLUSIONS: Implementing the guidelines to the treatment of AOM in children was associated with extra health benefits at slightly lower direct costs and, thus, is a dominant strategy. The focus of this study was on the short-term effects of the treatment; including long-term effects in the analysis might affect the results.

Acute Disease↗

Management of pain in acute otitis media in Finnish primary care.

Most treatment recommendations for acute otitis media favour active use of pain relief medication. These data comprised 3059 Finnish primary care acute otitis media patients. We found that 10.4% of the patients were prescribed or recommended analgesics, which is in contrast to treatment recommendations.

Acute Disease↗

Effectiveness of upper and lower limb casting and orthoses in children with cerebral palsy: an overview of review articles.

The objective of this overview is to summarize from systematic reviews the evidence on the effectiveness of using upper and lower limb casting or orthoses in children with cerebral palsy. We used computerized bibliographic databases to search for systematic reviews without any language restrictions. Identification, selection, quality assessment, and data extraction were performed independently by two investigators. Of the 40 identified reviews, 23 were selected for closer consideration, and five reviews met the inclusion criteria. The quality of existing systematic reviews and original studies included in our reviews varied widely. The following evidence was found: (1) casting of lower limbs has a short-term effect on passive range of movement; (2) orthoses that restrict ankle plantar flexion have a favorable effect on an equinus walk, but the long-term clinical significance is unclear; (3) evidence on managing upper limb problems with casting or splinting in children with cerebral palsy is inconclusive. Our conclusion is that there is a paucity of evidence from primary studies on the use of orthoses in children with cerebral palsy. More original, well-designed research is needed.

Activities of Daily Living↗

Quality of reporting of randomized, controlled trials in cerebral palsy.

OBJECTIVES: In conducting reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy, the assessment of trials can be hampered by problems in reporting. Therefore, we set out to evaluate trial reporting by using the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations. METHODS: Randomized, controlled trials published in 1990 or later were identified in literature searches for reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy. Two independent reviewers evaluated the trial reporting by using a modified 33-item Consolidated Standards of Reporting Trials checklist. RESULTS: We identified 15 randomized, controlled trials. Almost half (48%) of the applicable items were reported adequately. Inadequate reporting was found in the following items: outcome measures, sample-size determination, details of the sequence generation, allocation concealment and implementation of the randomization, success of assessor blinding, recruitment and follow-up dates, intention-to-treat analysis, precision of the effect size, co-interventions, and adverse events. CONCLUSIONS: Only a small number of sufficiently reported trials were found. Because nearly all items had been described in at least 1 article, high-quality reporting seems feasible. Assessment of trials depends on appropriate reporting, and poor reporting jeopardizes judgments on the clinical implications. Authors of randomized, controlled trials are encouraged to follow the Consolidated Standards of Reporting Trials criteria. There is a clear need to improve the quality of reporting of trials in this field.

Cerebral Palsy↗

Clinical guidelines: quality and implementation.

So far 60 evidence-based clinical guidelines have been developed in Finland. These are no binding rules, but they require interpretation for specific patients, and patient preferences are to be observed. For high-quality guidelines, surrogate markers must be avoided, evidence must be systematically searched for and presented, and local context has to be taken into account. The AGREE (Appraisal of Guideline Research & Evaluation) instrument for evaluation of guidelines is presented. Research on implementation and continuous evaluation of guideline effects are needed.

Evidence-Based Medicine↗

Prescription rates and diagnostic patterns are stable: a comparison of high-, medium- and low-prescribing primary care physicians treating community-acquired respiratory tract infections.

The objective was to study prescription practices of primary care physicians in prescribing antibiotics for community-acquired respiratory tract infections. Design was time series analysis and cross-sectional survey. The setting was 30 community primary health care centres. A case report form was completed for 3478 patient consultations treated by 198 office-based primary care physicians. Main outcome measures were: classification of diagnoses of respiratory tract infections made by each physician; number of antibiotic prescriptions related to these diagnoses; each physician's mean weekly number of antibiotic prescriptions during 6 months before and after the survey. Patients' risk (odds ratio: OR) to receive an antibiotic prescription from the high and medium prescribers was 5.81 (95% confidence interval [CI] 4.85-6.96) and 2.41 (95% CI 2.04-2.86), compared to low prescribers. High and medium prescribers made more diagnoses of otitis media (OR 2.07, 95% CI 1.70-2.53 and 1.85, 95% CI 1.51-2.26, respectively) and fewer diagnoses of unspecified upper respiratory tract infection (OR 0.32, 95% CI 0.26-0.38 and 0.57, 95% CI 0.48-0.68, respectively) than low prescribers. The rank of the prescription rate of high, medium and low prescriber groups remained the same for all diagnoses except pneumonia. In addition, the annual rank between high, medium and low prescriber groups remained stable; high group prescribed more antibiotics during the year than medium group, which prescribed more than low prescriber group.

Anti-Bacterial Agents↗

Expanding screening for rare metabolic disease in the newborn: an analysis of costs, effect and ethical consequences for decision-making in Finland.

AIM: Currently, the only metabolic disorder that newborns are screened for in Finland is congenital hypothyroidism. A proposal to start a pilot study on screening for other rare metabolic diseases using tandem mass spectrometry prompted a health technology assessment project on the effect and costs of expanded newborn screening programme options. METHOD: A modelling study using data from current published studies, healthcare registers and expert opinion. RESULTS: The annual running cost of screening 56,000 newborns for the chosen five disorders (congenital adrenal hyperplasia, medium-chain acyl-CoA dehydrogenase deficiency [MCADD], long chain 3-hydroxyacyl-CoA dehydrogenase deficiency [LCHADD], phenylketonuria [PKU] and glutaric aciduria type 1 [GA 1]) was estimated to be euros 2.5 million or euros 45 per newborn when starting costs were included. The costs per quality-adjusted life year (QALY) gained are a maximum of euros 25,500. Prevention of severe handicap in one newborn would reduce the costs to a maximum of euros 18,000 per QALY gained. CONCLUSIONS: Expanding the Finnish neonatal screening programme would require a new organization. The cost-effectiveness, resources, ethics and equity need to be considered when deciding in favour of or against starting a new screening programme.

Cost-Benefit Analysis↗

Acute sinusitis: Finnish clinical practice guidelines.

These clinical practice guidelines aim at providing assistance mainly to primary health care physicians for the diagnosis and management of acute sinusitis. Despite the huge impact of upper respiratory infections, criteria for diagnoses are often vague, and physicians are often uncertain of their diagnoses. This is not surprising, as the sole definition of acute sinusitis is somewhat confusing, not to mention the existing discrepancies between treatments, even among specialists. The Finnish Society of Otorhinolaryngology has set up a committee to evaluate existing data on acute sinusitis and to formulate these guidelines. The committee comprised Finnish experts in adult and paediatric otorhinolaryngology, clinical microbiology, radiology, paediatrics, and epidemiology. Recommendations given are based on the principles of evidence-based medicine, with the level of evidence presented.

Acute Disease↗

Management of acute maxillary sinusitis in Finnish primary care. Results from the nationwide MIKSTRA study.

OBJECTIVES: To study the management of acute maxillary sinusitis (AMS) in Finnish primary care and to compare it both to recommendations in national guidelines and to the management of other upper respiratory tract infections (URTI). DESIGN: A cross-sectional multi-centre epidemiological survey. SETTING: Thirty primary care health centres in Finland. SUBJECTS: 7284 patients with symptoms of possible acute rhinosinusitis during one week in both November 1998 and November 1999. MAIN OUTCOME MEASURE: Symptoms and their duration, use of diagnostic tools, choice of antibiotics, patient outcomes. RESULTS: A total of 1601 patients were diagnosed as having AMS (12% of all patients with infectious disease). In 45% of cases the differentiation between AMS and URTI was based on clinical examination alone. Sinus ultrasound was the most common diagnostic tool used (38%). Sinus radiography or blood tests (CRP or leukocytes) were both studied in 8% of cases. AMS was diagnosed and treated with antibiotics also in the early stages of URTI when viruses are the most likely explanation. In total, 83% of patients with AMS received a prescription for antibiotics; the most common choice was amoxycillin (37%), doxycycline was used in 29% of cases, and macrolides in 15%. CONCLUSIONS: Antibiotics are prescribed for AMS 2 to 5 times more often than true disease incidence would suggest in Finland. The choice of antibiotics follows the guideline recommendations; however, use of macrolides is higher than recommended. Physicians feel strong pressure from patients to prescribe antibiotics for AMS. Primary care physicians need better support in the accurate diagnosis of AMS.

Acute Disease↗

Evidence-based medicine in general practice: helping the whole patient.

This article is based on a keynote presentation at the 13th Nordic Congress in General Practice in Helsinki, Finland in September 2003. The aim was to demonstrate the strengths and limitations of evidence-based medicine (EBM) in a primary healthcare setting, and to show how and why it also can represent a hindrance to optimal medical care. The presentation comprised two separate lectures. Initially, Marjukka Mäkelä pointed to strengths to underline the need for EBM in general practice. Subsequently, Irene Hetlevik argued that the concept of EBM, on the contrary, could be a hindrance for good general practice.

Education, Medical, Continuing↗

Treatment of acute rhinosinusitis diagnosed by clinical criteria or ultrasound in primary care. A placebo-controlled randomised trial.

OBJECTIVES: To compare antibiotics and placebo in patients with clinically diagnosed acute maxillary sinusitis (AMS). To study whether sinus ultrasound examination would help to detect those patients who benefit from antibiotic therapy. DESIGN: A double-blind, randomised, placebo-controlled multicentre trial. SETTING: Nine primary care sites in Finland. SUBJECTS: 150 adult patients (mean age 39.7 years) with a clinical diagnosis of sinusitis. INTERVENTION: Antibiotics (amoxicillin 750 mg x 2, doxycycline 100 mg x 2 or penicillin V 1500 mg x 2) or placebo twice daily for 7 days; all patients were examined with sinus ultrasound after randomisation. MAIN OUTCOME MEASURE: Clinical success (patients' report of recovery) in telephone interview at 2 weeks. RESULTS: A total of 146 patients completed the 2-week follow-up. Patients receiving antibiotics achieved a slightly higher rate of clinical success than patients receiving placebo (80% vs 66%; p = 0.068). CONCLUSIONS: Antibiotics hasten symptom relief in AMS. Yet many patients recover in 2 weeks without antimicrobial treatment. Only half of patients with a clinical diagnosis of AMS have sinusitis in ultrasound examination.

Acute Disease↗