Research protocols
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The SEFO and EOM’s research lines for the following years will be carried out in 3 phases:
1) VALIDATION OF A DIAGNOSTIC TEST:The objective of this type of study is to estimate the SENSITIVITY (proportion of true positives) and SPECIFICITY (proportion of true negatives) of the osteopathic test. These are the operative characteristics of a diagnostic test. They measure the value of a diagnostic test.
Referring to a diagnostic test, this is the proportion of truly ill people who have been catalogued as such by means of this test.
The specificity is the proportion of true negatives. Its complementary values, that is, the proportion of false positives and false negatives, are also used as indices of error. A DIAGNOSTIC TEST MUST BE SENSITIVE (THAT IS, BE ABLE TO DETECT) AND SPECIFIC (CORRECTLY DETECT WHAT ONE WANTS TO DETECT). CARRIE OUT A RANDOM CONTROLLED OBSERVATIONAL DOUBLE-BLIND STUDY:
The study methodology should include the Inclusion/Exclusion criteria for each group. On many occasions there is no objective standard, for example, radiography, histology test, etc. In this case, “consensus among the judges” can be used to decide who is ill and who is healthy. It is necessary to know his interexaminator degree of agreement measured with the Kappa coefficient or other tests (3 or 4 examinators carry out the same steps: the person who carries out the study does not know their decision).
Measures of agreement:
Double or triple-blinded, being aware of the difficulties facing osteopathy on this point, requiring special attention in the study design. Several variables are studied: the sensitivity and specificity should be accompanied by their Confidence Interval. Several variables are studied:
We should remember on this point that these variables may also be:
The normality of the population must be studied (Smirnov-Kolgorov). If the distributions are not normal (Gaussian), use non-parametric tests such as the Mann-Whitney U test (2x2) or the Kruskall-Wallis test for more than two groups. The protocol used for Algometry and X-rays has to be scientific (rigorous in its application, identical for each patient), all the examiners should be instructed that they must all do the same thing, in the same way, in each patient (the same for the osteopathic test).
This type of statistics should include, mean, mode, median, maximum, minimum, confidence interval range, variance, standard deviation of ALL the variables ALWAYS. 2) STUDY OF THE EFFECTS OF A MANIPULATION:Measuring tools: should always measure several values.
The objective is to estimate the effect of an intervention or technique on pain, mobility, function etc.). THE STUDY MUST BE EXPERIMENTAL CONTROLLED RANDOMIZED, SIMPLE OR DOUBLE BLIND. The patient groups, in the intervention or study group and the control group, are patients with the same pathology who are randomly distributed between the two groups. Both groups should be the same and with the same number of people, this is a key factor. The inclusion/exclusion criteria should be identical for both groups. NOTE: BY DEFINITION THE STUDY GROUP AND CONTROL GROUP CANNOT BE MADE UP OF HEALTHY PEOPLE, IT IS OBLIGATORY TO USE POPULATIONS OF PATIENTS WITH THE SAME PATHOLOGY The realization of measurements (tests, etc) must be interexaminator with Kappa coefficient (3 or 4 examinators carry out the same steps: the person who carries out the study cannot take part as examinator but can carry out the technique). To employ in this kind of study the purpose of the Kappa coefficient is to show that measurements obtained (outcome) are independent of which obtains them. The operator who carries out the technique must be submitted to a intra-examinator with Kappa In this case, it is IMPOSSIBLE for the study to be double-blinded since the researcher, if he/she performs the osteopathic technique, knows who has received the real intervention and who has received the false one, the placebo or another different one. Therefore, as well as blinding the patients, he/she only performs the technique and the result is examined by other observers (several with a known degree of agreement, here the Kappa coefficient would be applied) who in a blinded way (they do not know which technique each patient has received) evaluate the result, that is, the effect. Several variables are studied:
The normality of the population must study (Smirnov-Kolgorov). If the distributions are not normal (Gaussian), use non-parametric tests such as the Mann-Whitney U test (2x2) or Kruskall-Wallis test for more than two groups. This type of statistics should include: mean, mode, median, maximum, minimum, confidence interval ranges, variance, and standard deviation of ALL the variables ALWAYS. STUDY AND CONTROL GROUPS: 50 patients
This is a group of patients with the same inclusion/exclusion factors: the reference group for comparison. The sample number must be identical to the study group. (If there are minimum differences of n due to randomization, they are admissible if the distribution continues to be normal and there are enough patients). They may be untreated or given a placebo treatment (according to ethics) or given another treatment (drug protocols, referenced in literature).
This is the group we want to study, comparing it to the reference group, in order to find out the validity of a diagnostic test, a technique or a treatment. All the patients in the group should present exactly the same problem, same lesions, same symptoms, etc. The intervention (treatment technique, number of sessions, periodical frequency, etc) should be identical for all the members of the group. The type of pathology we are treating should also be standardized (inclusion criteria). 3) OSTEOPATHIC EPIDEMIOLOGICAL STUDIES:These are studies of the osteopathic dysfunctions associated with a disease. Studies with a minimum of 300 cases of the diseases indicated for osteopathy. They should include:
This is a type of case-control, cross-sectional descriptive study with Odds Ratio, (minimum of 300 cases) or cohort study (300 to 500 patients at least in each group). There are guidelines to talk about causal effect (Bradford Hill). Hill’s causal relationship: gives cohort study, checks more things, helps to see the incidence. The cohort study is more difficult than the case-control study. It enables an association to be established but not the incidence. The cohort study enables the study of temporality (the cause is before the effect), dose-gradient (treatment) / effect (result), consistency (regardless of age, sex, country), the plausibility (it can be explained), experimental reproduction. 4) STUDY ON THE EFFECT OF AN OSTEOPATHIC TREATMENT PROTOCOL ON DISEASE X:Randomized controlled case-control clinical trial or much better random experimental controlled blind study with:
Use osteopathic diagnostic tests which are already scientifically validated. Exhaustive description of the details of how the tests were carried out and the techniques used. Identical treatment protocol for each patient. The normality of the population must study (Smirnov-Kolgorov). NOTE: THE CRITERIA ARE IDENTICAL TO THOSE TO STUDY THE EFFECTS OF A TECHNIQUE |