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Hypothesis/Aims of study
Many results related to the effectiveness of surgical and non-surgical proce- dures for treating urinary incontinence (UI) are reported in the literature. Following the principles of evidence based-practice, besides the interpreta- tion of study results based on statistical significance, authors should consid- er evaluating the clinical relevance of treatment effects in this field.
The minimal important difference (MID) of clinical outcomes could be used to assess the clinical relevance of interventions. MID is defined as “the small- est difference in score in the domain of interest that patients perceive as important, either beneficial or harmful, and which would lead the clinician to consider a change in the patient’s management’’[1]. One common way to obtain MID for outcomes of interest is by using anchor-based methods. These methods apply one anchor that analyzes the change in the patient's health status according to the patient’s perception.
However, MIDs should be provided according to appropriate calculations and methods and based on the definition of a MID. However, there are a lot of misconceptions and misunderstandings related to the MID. These mis- understandings have led to incorrect reports of these values. Moreover, it is still not known which criteria the authors considered during the analysis of the MID in the Women’s Health area. Therefore, with this preliminary re- port, we aimed to identify and report all anchor-based methods to estimate MIDs for outcomes measures related to UI available in the literature; and analyze which concepts and levels of improvement in the health status of the patient have been considered by the authors to calculate the MID.
Study design, materials and methods
This systematic review was conducted according to PRISMA guide- lines. The study protocol was registered in the PROSPERO database (CRD42022299686). A systematic search was performed using Ovid Med- line, Embase, Web of Science, and Scopus from May to June 2021. Any study generating MIDs for UI that included women with more than 18 years, stress urinary incontinence (SUI), urgency urinary incontinence (UUI) and/ or miXed urinary incontinence (MUI) was included. The primary outcome was the MID for outcomes related to UI. No limits were applied on the data- bases for the date, language or publication range.
Studies were classified into three categories according to the level of im- provement in health status assessed by the anchor and considered by the authors during the MID calculation: 1) slight improvement: if authors in- cluded participants that evaluated their health status as “a little better” in their analysis; 2) moderate improvement: if authors considered women that reported a “better” or a “much better” status of the condition; or 3) strong imporvement: if all patients that improved (“very much better” or if authors grouped all the patients that improved in one single category) were consid- ered in one group against other group that did not report any improvement. After classifying the papers, we counted and reported how many studies were considering only the minimal level of improvement to reported the MID, according to previous definition and recommendation.
The initial electronic search resulted in a total of 1,662. After removing du- plicates (n=719), 943 were screened, and at the end of the selection stages, nine papers that reported anchor-analysis were included in this preliminary report. Seven studies included women with SUI (total sample size= 2,436), while one study included only women with UUI (n=307), and the other one evaluated women with SUI and MUI (n=288). SiX studies analyzed data and provided the MID after a non-surgical treatment of UI, while three analyzed the results after surgery to correct UI. Eleven different questionnaires to measure the patient-related outcomes related to UI with their MIDs were identified. All the tools were related to measuring the impact, distress, or quality of life of women with UI.
Different anchors were used to analyze MID, including scales that evaluated the improvement and satisfaction of the patient, and the visual analogue scale, measures of urinary leakage and questionnaires that measure the se- verity and impact of UI. The MID of siX tools was determined according to the smallest difference detected by the patients, using the Patient Global Im- pression of Improvement questionnaire and the self-reported satisfaction to assess the change of the condition. Most of the MIDs (n=28, 80%) were mis- calculated considering a moderate or a strong improvement of the patients, and not a minimal improvement as suggested by the literature (Table 1).
Interpretation of results
Although previous systematic reviews have reported the psychometric prop- erties of different questionnaires to measure UI outcomes, this is the first study to analyze methods of obtaining MIDs for UI outcomes from the pa- tients perspective (anchor based methods). All the tools with their respec- tives MIDs were related to the impact, distress, and/or quality of life of women with UI. The use of these outcomes measures is in line with the as- sociated impairments of social, psychological, financial, and sexual aspects of a women’s life produced by UI.
Most of the authors in this field did not consider the smallest difference identified by the participants to calculate the MID, which does not follow the original definition of MID proposed by Jaeschke et al.,1 This could gen- erate underestimation or over-estimation of MID, which may directly im- pact the interpretation of the findings from the clinical trials[2] and biased interpretation of the results of the clinical significance from the interven- tions used to manage female UI. Therefore, the interpretation of the clinical significance related to UI outcomes should be done with caution.
Concluding message
Few studies that aimed to calculate the MID using anchor-based methods for outcomes related to female UI were found in the literature. Eleven different questionnaires to measure the outcomes related to UI with their MIDs were identified. However, most studies had not considered the smallest change of improvement (as perceived by the patients) in their analysis, which does not follow the definition of the MID. This could impact decision making. Future research should provide clear guidelines on how to calculate, report, and interpret MIDs in this field.
Despite normal neurological bedside and electrodiagnostic, some patients with non-specific neck arm pain (NSNAP) have heightened nerve mechanosensitivity upon neurodynamic testing [1, 2]. It remains however unclear whether this is associated with a minor nerve injury. The aim of this study was to evaluate potential differences in somatosensory function among patients with unilateral NSNAP with and without positive neurodynamic tests and healthy controls.
Quantitative sensory testing was performed in 40 patients with unilateral NSNAP; 23 with positive upper limb neurodynamic tests (ULNTPOS) and 17 with negative neurodynamic tests (ULNTNEG). The protocol comprised thermal and mechanical detection and pain thresholds as well as mechanical pain sensitivity, wind-up ratio and dynamic mechanical allodynia. All parameters were measured in the maximal pain area on the affected side as well as over the corresponding area on the unaffected side. Symptom severity, functional deficits, psychological parameters, quality of life and sleep disturbance were also recorded.
Fifty-seven percent of patients with NSNAP had positive neurodynamic tests despite normal bedside neurological integrity tests and nerve conduction parameters. Clinical profiles did not differ between patient groups. Somatosensory profiling revealed a more pronounced loss of function phenotype in ULNTPOS patients compared to healthy controls. Hyperalgesia (cold, heat and pressure pain) was present bilaterally in both NSNAP group. The ULNTNEG subgroup represented an intermediate phenotype between ULNTPOS patients and healthy controls in both thermal and pressure pain thresholds as well as mechanical detection thresholds.
In conclusion, heightened nerve mechanosensitivity was present in over half of patients with NSNAP. Our data suggest that NSNAP presents as a spectrum with some patients showing signs suggestive of a minor nerve dysfunction.
[1] Elvey RL. Physical evaluation of the peripheral nervous system in disorders of pain and dysfunction. J Hand Ther 1997;10:122-129.
[2] van der Heide B, Bourgoin C, Eils G, Garnevall B, Blackmore M. Test-retest reliability and face validity of a modified neural tissue provocation test in patients with cervicobrachial pain syndrome. J Man Manip Ther 2006;14:30-36.
Die Deutsche Gesellschaft für Hebammenwissenschaft (DGHWi) begrüßt die im Juli 2012 verabschiedeten Empfehlungen des Wissenschaftsrates (WR) zu den hochschulischen Qualifikationen für das Gesundheitswesen, hält jedoch Differenzierungen bei der Betrachtung der einzelnen Gesundheitsfachberufe für geboten und bezieht im folgenden Stellung zu den grundlegenden Aspekten, die sich auf die Entwicklung des Hebammenberufes bzw. die Hebammenwissenschaft beziehen.
Die Deutsche Gesellschaft für Hebammenwissenschaft e.V. (DGHWi) verfolgt die Entwicklung rund um den Deutschen Qualifi-kationsrahmen für lebenslanges Lernen (DQR) mit großem Interes-se. Die DGHWi begrüßt die mit Stand vom 1.5.2013 vereinbarte Zurückstellung der Zuordnung der bundesrechtlich geregelten Ge-sundheitsfachberufe. Die ursprünglich geplante Zuordnung des Hebammenberufs auf DQR Niveaustufe 4 wird als unvereinbar mit der hohen Anforderungsstruktur der Qualifikation der Berufsgruppe betrachtet. Darüber hinaus ist diese Zuordnung nicht mit der zuneh-menden Qualifizierung von Berufsangehörigen auf tertiärem Bil-dungsniveau vereinbar. Die DGHWi plädiert mit Nachdruck für eine Höherstufung der derzeitigen beruflichen Erstqualifikation von Heb-ammen* an Berufsfachschulen auf DQR Niveau 5 und fordert wie-derholt die komplette Anhebung der Hebammenausbildung auf Bachelorniveau, das der Qualifikationsstufe 6 im DQR entspricht.
Die Deutsche Gesellschaft für Hebammenwissenschaft e. V. (DGHWi) fordert den EU-Ministerrat und das Europaparlament auf, der Änderung der europäischen Berufsanerkennungsrichtlinie zuzustimmen. Die DGHWi e. V. fordert die Bundesregierung auf, die in der Neufassung der europäischen Berufsanerkennungsrichtlinie vorgesehene Anhebung der Schulausbildung von zehn auf zwölf Jahre unter der Prämisse der Erlangung der Hochschulzugangsberechtigung umzusetzen.
Die Prüfung des Risikofrüherkennungssystems sollte einen klaren Fokus auf Vorgehensweisen und Methoden der Unternehmensetzen, die genutzt werden,um mögliche „bestandsgefährdende Entwicklungen“ (§91 Abs. 2 AktG) rechtzeitigzu erkennen. Sie ergeben sichaus schwerwiegenden Einzelrisiken aber vor allemauch aus Kombinationseffekten von Risiken. Wir empfehlen insbesondere, die dadurch erforderlichenmethodischen Anforderungen im Prüfungsstandard klarer als bisher zu formulieren, die Verwendung dieser Methoden eindeutig vorzuschreiben und den Einsatz offensichtlich ungeeigneter Verfahren konsequent als schwerwiegenden Mangel eines Risikofrüherkennungssystems darzustellen (z.B. Verfahren einer „qualitativen Risikoaggregation“ statt einer Monte-Carlo-Simulation). Eine Prüfung nach IDW PS 340 muss zur Erfüllung der gesetzlichen Anforderungen beispielsweiseuntersuchen, ob die finanziellen Auswirkungen aller gravierenden Risiken quantifiziert wurden, Kombinationseffekte von Einzelrisiken mittels Monte-Carlo-Simulation und unter Bezug zur Unternehmensplanung (und damit dem Risikodeckungspotenzial) aggregiert wurden und die Möglichkeit bestandsgefährdender Entwicklungen umfassend untersucht wurde (z.B. speziell auch eine Bestandsgefährdung durch eine (drohende) Illiquidität, die durch das Verletzen der Regeln überMindestanforderungen an das zukünftige Finanzrating oder von Covenants, die zu Kreditkündigungen führen können, ausgelöst werden). Um dies zu gewährleisten, muss speziell auch geprüft werden, inwieweit das Unternehmen den Begriff der „bestandsgefährdenden Entwicklung“ überhaupt adäquat und hinreichend umfassend definiert hat. Neben diesen Kernpunkten aus gesetzlicher Perspektive bietet die Stellungnahme eine Reihe weiterer Verbesserungsvorschläge und Empfehlungen zur Anpassung der Formulierungen.
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