Research protocols

The SEFO and EOM’s research lines for the following years will be carried out in 3 phases:

1. Validation of osteopathic tests and the effects of osteopathic techniques.
2. Then, osteopathic epidemiological studies (cohort studies) of diseases suitable for osteopathy.
3. And only then, studies on the therapeutic results of osteopathic treatment protocols (case-control studies).

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.

• SENSITIVITY (SYNONYM: TRUE POSITIVE RATE)

Referring to a diagnostic test, this is the proportion of truly ill people who have been catalogued as such by means of this test.

• SPECIFICITY (SYNONYM: TRUE NEGATIVE RATE)

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).

A non-random cross-sectional observational study is carried out:

• Control group of healthy patients and study group with pathology regarding the test studied: same number of people in each group.
• The subjects in the two groups can be classified: prior to the start of the study (a priori), by means of the evaluation and results of the Gold Standard technique (a posteriori), or by means of the evaluation and results of the osteopathic test that we are evaluating (a posteriori).
• There must be a benchmark (Gold Standard, reference test*) which identifies healthy and ill people.

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.

The degree of interexaminer agreement should be known, measured with the Kappa coefficient or other tests (3 or 4 examiners perform the same steps: the person who carries out the study ignores their decision).

• Interexaminer with Kappa coefficient - 3 or 4 examiners perform the same steps: the person who carries out the study cannot participate as an examiner.
• The examiner who does the osteopathic test should not know whether the subject is healthy or ill (independent and blind verification).
• The benchmark should have been established without knowing the result of the osteopathic test. The objective is to estimate the RELIABILITY, degree of agreement or interchangeability among observers.
• The Kappa coefficient can only be used for qualitative (test) variables (most osteopathic tests are dichotomous, so it is very valid). In the case of quantitative variables, the results should be categorized (classify in intervals) or use other statistical graphs different from Kappa.

Measures of agreement:

• Kappa coefficient for qualitative variables, YES/NO: Example X-rays; Kappa between 0 and 1.
• Statistical contrast with McNemar non-parametric test (2x2). (Impossible without computer statistics programme).
• Intraclass Correlation Coefficient (ICC) for quantitative variables. Example, algometry or VAS. ICC between 0 and 1.
• Statistical contrast (F test) (Impossible without computer statistics programme).

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:

• Principal or dependent variable: Pain, mobility, function, etc.
• Independent variables: age, sex, severity, etc.

We should remember on this point that these variables may also be:

• Quantitative variables (algometry* or VAS): compares means with parametric Student’s t-tests, two groups, or ANOVA if more than two groups.

• Qualitative variables (X ray*, Yes/No, present/absent; healed/not healed): compares proportions, Chi-squared.

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).

• Algometry: Know the error margin of the apparatus, protocol concerning location of the painful area (Trigger) to be studied, protocol of the use of the algometer (angle of inclination position).
• Radiographs: Strict positioning protocol of patient and articulation to be studied (possible construction of a frame to fix an identical articular position in each patient), orientation of X-rays always identical, articulation-X-ray tube distance always identical.
• Photography: Strict positioning protocol of patient and articulation to be studied (possible construction of a frame to fix an identical articular position in each patient), camera orientation always identical. With Photoshop the same type of image always (TIFF), same image size, measure in millimetres or count pixels.

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.

• X-rays and radiological measurements.
• MRI.
• Goniometry (NB: classical goniometers are not validated given their poor reliability).
• Algometry (algometers, VAS, validated questionnaires, etc)
• EMG.
• ECG.
• EEG.
• Blood or urine tests.
• Doppler.
• Use osteopathic diagnostic tests already scientifically validated.

The objective is to estimate the effect of an intervention or technique on pain, mobility, function etc.).

THE STUDY SHOULD BE RANDOMIZED CONTROLLED AND EXPERIMENTAL.

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.

The study should be interexaminer with Kappa coefficient (3 or 4 examiners perform the same steps: the person who carries out the study cannot participate as an examiner but can perform the technique). In this type of study, the Kappa coefficient should be used in order to demonstrate that the measures obtained (outcome) are independent from the person who obtains them.

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:

• Principal or dependent variable: Pain, mobility, function, etc.
• Independent variables: age, sex, severity, etc.
• We should remember in this point that these variables can also be:
• Quantitative variables (algometry or VAS): compares means with parametric Student’s t-tests, two groups, or ANOVA if more than two groups.
• Qualitative variables (X ray, Yes/No, present/absent; healed/not healed): compares proportions, Chi-squared.

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

• Enough patients in each group (and balanced).
• Depend on the inclusion/exclusion criteria.
• Random samples (systematic chance) if a technique is studied (not of use if the validation of an osteopathic test is studied).

• CONTROL GROUP:

This is a group of healthy patients or 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).

• STUDY GROUP:

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:

• Inclusion and exclusion factors.
• Random study groups/Control groups.
• Double or triple-blinded interobserver.

This is a type of case-control, cross-sectional descriptive study with Odds Ratio, (minimum of 50 cases) or cohort study (100 to 200 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 with:

• Inclusion and exclusion factors.
• Random study group/control control with simulation (placebo) with pathology.
• Double or triple-blinded interobserver with Kappa.
• Type of statistics: Sensitivity and specificity of the test with its confidence interval.
• Many variables with many sub-groups for each type of protocol with multivariate complex stratified analysis.
• Needs a very big population.
• Measuring instruments: several values should always be measured.

• X-rays and radiological measures
• Goniometry
• Algometry
• EMG
• ECG
• EEG
• Blood and urine tests
• Doppler
• MRI

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.