RU2640998C1 - Method for diagnostics of primary hyperparathyroidism by questionnaire for assessment of clinical symptomatics - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: patient is offered a questionnaire for clinical symptoms assessment. The questionnaire includes 12 questions corresponding to the most frequent complaints among patients with primary hyperparathyroidism, which are divided into 3 domains according to the systems of organs to which they relate: 1- I constantly feel weakness; 2 - drowsiness after getting up in the morning; 3 - it is difficult for me to walk for a long time, I suffocate if I have to go fast; 4 - it is difficult for me to fulfil and it is necessary to limit my leisure time and household duties. Visceral: 1 - back pain; 2 - pain/aches in bones and joints; 3 - I am constantly thirsty; 4 - pain in the abdomen, heartburn, constipation. Psychological: 1 - I feel irritable; 2 - I have a constantly bad mood/depression; 3 - because of the disease, I do not sleep well and wake up at night; 4 - I find it difficult to concentrate on my work. Each positive answer is considered as 1 point. Symptoms severity is assessed by the sum on a 12-point scale and the sum in each of the three domains is assessed separately as a result of objective assessments of clinical symptoms severity.EFFECT: method allows to obtain precise estimates of the severity of the clinical symptoms of primary hyperparathyroidism, and separately - the manifestation of symptoms associated with the various systems of organs, through evaluation of the clinical symptoms severity.2 ex

Description

The invention relates to medicine, in particular to a method for diagnosing diseases, including questionnaires, and can be used to diagnose primary hyperparathyroidism.

Similar tools were previously proposed by various authors. The most frequently mentioned and applicable of these are the Pasieka Questionnaire (PAS) proposed by Pasieka J.L. et al. (Pasieka JL, Parsons LL. Prospective surgical outcome study of relief of symptoms following surgery in patients with primary hyperparathyroidism. World J. Surg. 1998; 22: 513-518), as well as the SF-36 questionnaire (Ware, JE, Sherbourne, CD. The MOS 36-item short-form health survey (SF-36): I, conceptual framework and item selection. Med Care. 1992; 30: 473-483).

The PAS questionnaire includes 13 questions, the answers to which form an assessment of the severity of symptoms on a scale from 0 to 1300. Its disadvantages include the lack of separation of symptoms into groups belonging to different organ systems, which does not allow differentiating different clinical forms of the disease and also evaluate the dynamics of various groups of symptoms depending on the treatment. This separation of symptoms into groups may be useful, given the different specificity of the symptoms with respect to primary hyperparathyroidism. In addition, the questionnaire is difficult for patients to interpret, as requires evaluating the severity of symptoms on a 100-point scale.

As a prototype (the closest analogue), we chose the SF-36 questionnaire, which allows you to evaluate the health-related quality of life and contains 36 questions regarding the well-being, mood of the patient. The disadvantages of this questionnaire are cumbersome (36 questions), lack of focus on the symptoms of primary hyperparathyroidism (it is used to diagnose various diseases), similarity and uniformity of some of the questions related to the general well-being of the patient.

The technical result of the invention is to obtain more accurate estimates of the severity of clinical symptoms of primary hyperparathyroidism, as well as separately - the severity of symptoms associated with various organ systems.

The technical result is achieved due to the fact that 12 complaints were most often presented by patients with hyperparathyroidism, according to studies examining the frequency of clinical symptoms of the disease in question (Webb SM, Puig-Domingo M., Villabona C. et al. Development of a new tool for assessing Health-Related Quality of Life in patients with primary hyperparathyroidism // Health Qual Life Outcomes. 2013 Jun 18; 11:97). The selected 12 most frequent symptoms were divided into 3 domains according to which organ systems they relate to: 1 - visceral symptoms, 2 - somatic symptoms, 3 - psychological symptoms.

The final questionnaire contains the following items:

1) Somatic symptoms:

I constantly feel weak;

Drowsiness after getting up in the morning;

It’s hard for me to walk for a long time, I gasp if I have to go fast;

It is difficult for me to fulfill and have to limit my leisure and domestic duties;

2) Visceral symptoms:

Lower back pain;

Pain / aches in bones and joints;

I am constantly thirsty;

Abdominal pain, heartburn, constipation;

3) Psychological symptoms:

I feel irritable;

I am constantly in a bad mood / depression;

Due to illness, I do not sleep well; I wake up at night;

I find it hard to concentrate on work.

Each positive response was counted for 1 point, the sum of which evaluated the severity of clinical symptoms on a 12-point scale before and after surgery. Separately, the total score in each of the three sections was evaluated. An example of the result obtained in patient D., 64 years old: before the operation - 8 points (visceral - 2, general somatic - 3, psychological - 3), after the operation - 4 points (visceral - 0, general somatic - 2, psychological - 2).

The fact of detection of distinctive features from previous techniques serves as the basis for the conclusion that the claimed method meets the criterion of "significant differences".

The questionnaire was used by the authors in the analysis of clinical symptoms before and after surgery in 108 patients operated on for primary hyperparathyroidism, as well as in studying the characteristics of a group of patients in whom hyperparathyroidism was combined with urolithiasis. The total score of clinical symptoms before surgery on average (median) was 4.5 points, interquartile distance - 3-6 points. The use of the questionnaire made it possible to show that in patients with urolithiasis, the clinical symptoms of primary hyperparathyroidism are more pronounced (p = 0.02). In patients with primary hyperparathyroidism in combination with urolithiasis, the median total score was 5 points. In patients without urolithiasis, the median score was 4 points.

The data from the questionnaires made it possible to show the clinical efficacy of surgical treatment of primary hyperparathyroidism. After the operation, the average value (median) of the total score decreased to 2 points, which became a statistically significant difference (p <0.01). It was also shown that in patients with urolithiasis, the sum of symptoms on average (median) decreased by 3 points, and in patients without urolithiasis, the median of the decrease in symptoms was 2 points. In patients with primary hyperparathyroidism combined with urolithiasis, surgical treatment brought a greater clinical effect according to the developed questionnaire (p = 0.005).

It was shown that visceral symptoms in patients with primary hyperparathyroidism combined with urolithiasis were statistically significantly more pronounced than in patients without urolithiasis (p> 0.01); their value was also statistically significantly greater, by which the total score of visceral symptoms after surgery decreased (p> 0.01). Moreover, visceral symptoms after surgery decreased more than general somatic and psychological. This emphasizes the importance of a separate assessment of symptom severity across domains.

Clinical examples

1. Patient G., 39 years old. the concentration of parathyroid hormone before surgery is 312 pg / ml, after surgery - 154 pg / ml. In this patient, primary hyperparathyroidism developed as part of the hereditary syndrome of multiple endocrine neoplasia. Previously, she had already undergone parathyroidectomy for a single parathyroid adenoma. This episode is a relapse of the disease. During the operation, 3 parathyroid glands were removed. After the operation, an increased level of parathyroid hormone remained, however, according to the questionnaire, the total score before the operation was 3 (visceral - 1, somatic - 0, psychological - 2), after the operation, the total score was 1 (visceral - 0, somatic - 0, psychological - 1) . Thus, the use of the questionnaire allows you to obtain objective (digitally expressed) data that allows you to judge the clinical effectiveness of the operation, despite persisting laboratory deviations.

2. Patient S., 43 years old. Before surgery, the patient's calcium level was 3.04 mmol / l, parathyroid hormone - 649 pg / ml, the total score of clinical symptoms was 7 points (visceral - 2, general somatic - 3, psychological - 2). As a result of the operation, the level of parathyroid hormone decreased to 119 pg / ml, however, the clinical symptoms did not change significantly: the total score was 6 points (visceral - 2, general somatic - 2, psychological - 2). In this case, the use of the questionnaire demonstrates the absence of a clinical effect from the operation and allows us to judge that the clinical symptoms were probably associated with another concomitant pathology.

Claims (1)

A method for assessing the effectiveness of surgical treatment of primary hyperparathyroidism, including a questionnaire for assessing clinical symptoms, characterized in that the questionnaire includes 12 questions corresponding to the most common complaints among patients with primary hyperparathyroidism, which are divided into 3 domains in accordance with the organ systems to which they belong: general symptoms: 1 - I constantly feel weak; 2 - drowsiness after getting up in the morning; 3 - it is difficult for me to go for a long time, I am suffocating if I have to go fast; 4 - it is difficult for me to perform and I have to limit my leisure and household duties, visceral symptoms: 1 - lower back pain; 2 - pain / aches in bones and joints; 3 - I am constantly thirsty; 4 - abdominal pain, heartburn, constipation, and psychological symptoms: 1 - I feel irritable; 2 - I am constantly in a bad mood / depression; 3 - due to illness I do not sleep well, wake up at night; 4 - I find it difficult to concentrate on work; the questionnaire is presented to the patient in the form of a questionnaire to fill out, each positive answer is considered to be 1 point, the sum of which assesses the severity of symptoms on a 12-point scale and separately estimates the total score in each of the three domains as a result of objective assessments of the severity of clinical symptoms.