study protocol for two randomized pragmatic trials

Background Chronic low back pain (LBP) and neck pain (NP) are highly prevalent conditions resulting in high economic costs. Treatment guidelines recommend relaxation techniques, such as progressive muscle relaxation, as adjuvant therapies. Self-care interventions could have the potential to reduce costs in the health care system, but their effectiveness, especially in a usual care setting, is unclear. The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone. Methods/design Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic (>12 weeks) LBP or NP and an average pain intensity of ≥ 4 on a numeric rating scale (NRS) in the 7 days before recruitment. The participants will be randomized into an intervention and a usual care group. The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization: autogenic training, mindfulness meditation, or guided imagery. Instructions and exercises will be provided using a smartphone app, baseline information will be collected using paper and pencil. Follow-up information (daily, weekly, and after 3 and 6 months) will be collected using electronic diaries and questionnaires included in the app. The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS (0 = no pain, 10 = worst possible pain). The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements, the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months, pain acceptance, ‘LBP- and NP-related’ stress, sick leave days, pain medication intake, adherence, suspected adverse reaction, and serious adverse events. Discussion The designed studies reflect a usual self- care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals

Understanding the role of health information in patients' experiences: secondary analysis of qualitative narrative interviews with people diagnosed with cancer in Germany

Objective To analyse the role and meaning of health information in individuals' experiences with either breast, colorectal or prostate cancer in order to better understand unmet information needs of people with a cancer diagnosis. Design This is a secondary analysis of data from a qualitative interview study including narrative interviews and maximum variation sampling. A thematic analysis was conducted, followed by an in-depth analysis based on the principles of grounded theory. Setting Interviewees were sought across Germany through self-help organisations, primary care clinics, rehabilitation facilities, physicians and other healthcare professionals to develop cancer modules for the website kr ankheitserfahrungen.de (illness experiences.de). Participants Women with a diagnosis of breast cancer, individuals with a diagnosis of colorectal cancer and men with a diagnosis of prostate cancer. Results The meaning and role of information in the illness experiences were clearly associated with gaining control in a seemingly uncontrollable situation in which others people, the disease take over. Four categories characterise the ways in which information helped interviewees to regain a sense of control following a diagnosis of cancer: 'becoming confident in one's treatment decision', 'taking responsibility for one's situation', 'understanding the consequences of the disease and treatment for one's life', and 'dealing with fear'. There was, however, always a fine line between information seeking and becoming overwhelmed by information. Conclusions Information needs to be understood as a management tool for handling the disease and its (potential) consequences. Patients' unmet needs for information might not be easily solved by a simple increase in the amount of information because emotional support and respect for patient autonomy might also play a role. The evaluation of one's own information behaviour and the information received is closely linked to how the illness unfolds. This makes it challenging to document unmet information needs and satisfaction with information independent of an individual's illness trajectory over time

App-Based Relaxation Exercises for Patients With Chronic Neck Pain: Pragmatic Randomized Trial

Background: Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. Objective: The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. Methods: Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week’s average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain–related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. Results: We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI −0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. Conclusions: The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques

Comparative effectiveness research in Chinese Medicine

Hintergrund/Zielstellung: Comparative Effectiveness Research (CER) beschreibt ein Forschungsfeld mit dem Ziel, Ergebnisse zu generieren, die alltagsrelevant sind. Die Arbeit hat drei primäre Ziele: (1) Entwicklung und Durchführung eines Stakeholderprozesses im Rahmen einer pragmatischen randomisierten Studie zu Akupressur bei Regelschmerzen (AKUD-Studie), (2) qualitative Untersuchung zu Teilnahmegründen von Frauen an der AKUD-Studie und welche Rolle eine Aufwandsentschädigung bei der Entscheidungsfindung spielt, (3) Evaluation der Effektivität von Qigong im Vergleich zu Rückenübungen bei chronischen Schmerzen der Lendenwirbelsäule (LWS). Methodik: (1) Quantitative und qualitative Methoden wurden angewandt, um Stakeholder bei der Planung der Studie einzubeziehen. Basierend auf den Ergebnissen eines Surveys und einer Fokusgruppendiskussion mit betroffenen Frauen wurde von einem Stakeholder Advisory Board das Studiendesign festgelegt. (2) Mit 25 der 220 Teilnehmerinnen der AKUD Studie wurden semistrukturierte Interviews durchgeführt, 10 davon gehörten in die Gruppe, die bereits bei der Rekrutierung von der Aufwandsentschädigung wussten. Die Kriterien für die Stichprobenwahl waren Zeitpunkt der Rekrutierung und Gruppenzuordnung. (3) 127 Patienten mit chronischen Schmerzen der LWS wurden in eine randomisierte Studie eingeschlossen und erhielten über 12 Wochen entweder Qigong (64 Patienten) oder Rückenübungen (63 Patienten). Es wurde eine Nichtunterlegenheitshypothese getestet. Der primäre Ergebnisparameter war die mittlere Schmerzintensität der letzten 7 Tage auf einer Visuellen Analog Skala (VAS, 0-100 mm, 0 = kein Schmerz, 100 = maximal vorstellbarer Schmerz, Nichtunterlegenheitsmarke = 5 mm) nach 3 Monaten. Ergebnisse: (1) Der Stakeholderprozess führte zum Design einer 2-armigen Studie mit Frauen im Alter von 18-25 Jahren und einer App als Interventions- und Datenerfassungsinstrument. (2) Die Frauen waren mit den Behandlungsoptionen für Regelschmerzen nicht zufrieden und die AKUD-App bot mit Akupressur eine für sie interessante Alternative. Darüberhinaus wollten AKUD-Teilnehmerinnen die therapeutische Bandbreite der medizinischen Versorgung für andere Frauen erweitern. Die Aufwandsentschädigung spielte für die Studienteilnahme eine untergeordnete Rolle. (3) Patienten in beiden Gruppen hatten eine Verbesserung der mittleren Schmerzintensität (Qigong: 34,8 mm [95% Konfidenzintervall (KI): 29,5;40,2]; Rückenübungen: 33,1 mm [95% KI: 27,7;38,4]). Die Differenz zwischen den Gruppen betrug -1,8 mm (95% KI -9,4 mm; 5,8 mm; p = 0,204, Nichtunterlegenheit nicht gezeigt). Diskussion: (1) Der Stakeholderprozess hatte einen relevanten Einfluss auf das Studiendesign. Medizinische Behandlungsmöglichkeiten zu erweitern, spielten eine Rolle im Entscheidungsprozess, während finanzielle Anreize eine untergeordnete Bedeutung hatten. (2) Die Publikation der Studienergebnisse von AKUD stehen aus, um die Relevanz von Akupressur bei Regelschmerzen beurteilen zu können. (3) Die Nichtunterlegenheit von Qigong im Vergleich zu Rückenübungen konnte nicht nachgewiesen werden (p-Wert: 0,204).Background/Aim: CER aims to generate results which are applicable in regular medical care. The thesis has three primary aims: (1) Development and implementation of a stakeholder process within a randomized pragmatic trial on acupressure for menstrual pain (AKUD-study), (2) a qualitative assessment of the reasons for participation in the AKUD-study and of the influence of financial compensation on the decision-making process, (3) Evaluation of the effectiveness of Qigong compared to exercise therapy in patients with chronic lower back pain (LBP). Methods: (1) Mixed-methods were used to engage stakeholders in the design of the study. Based on the results of a survey and focus group discussion with affected women a stakeholder advisory group designed the study. (2) Semistructured interviews were conducted with 25 out of 220 participants of AKUD. Of those, 10 women knew about the financial compensation at the time of recruitment. Sampling was purposeful. Selection criteria included time of recruitment and group allocation. (3) 127 patients with chronic LBP were randomized and received either Qigong (64 patients) or exercise therapy (63 patients) over 12 weeks. A non-inferiority hypothesis was tested. The primary outcome was the mean pain intensity in the last 7 days (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain, non-inferiority margin = 5 mm) at 3 months. Results: (1) Engagement of stakeholders resulted in a two-armed AKUD study that included women 18-25 years of age and used a smartphone app as an intervention and data-collecting tool. (2) The women were dissatisfied with the treatment options for menstrual pain and the AKUD-app offered with acupressure a non-pharmacological alternative. A further reason to participate in the AKUD-study was the desire to add a new therapy to medical care. The financial compensation was a subsidiary reason for study participation in the women’s narratives. (3) Mean pain intensity of LBP decreased in both groups after 3 months (Qigong 34.8 mm; 95% Confidence interval (CI): [29.5;40.2]; exercise: 33.1 mm [95% CI: 27.7;38.4]). Difference between groups was -1.8 mm (95 % CI: [-9.4;5.8]). Non-inferiority failed to show statistical significance (p=0.204). Discussion: (1) The stakeholder process had a relevant influence on the study design. The addition of medical options to care played an important role in the decision-making, whereas financial incentives played a minor role. (2) The study results of AKUD need to be published to evaluate the relevance of acupressure for menstrual pain. (3) Non-Inferiority of Qigong compared to exercise therapy could not be proven (p=0.204)

Women's reasons for participation in a clinical trial for menstrual pain: a qualitative study

OBJECTIVES: The aim of the study was to explore women's motivations for participating in a clinical trial and to evaluate how financial compensation impacts women's explanations for participation. DESIGN, SETTING AND PARTICIPANTS: Semistructured interviews were conducted face to face or by telephone with 25 of 220 women who participated in a pragmatic randomised trial for app-administered self-care acupressure for dysmenorrhoea (AKUD). Of these 25 women, 10 had entered AKUD knowing they would receive a financial compensation of €30. A purposive sampling strategy was used. RESULTS: Women had a long history of seeking help and were unsatisfied with the options available, namely painkillers and oral contraceptives. While interviewees were open to painkillers, they were uneasy about taking them on a monthly basis. The AKUD trial offered the possibility to find an alternative solution. A second reason for participation was the desire to add a new treatment to routine medical care, for which the interviewees considered randomised trials a prerequisite. The financial incentive was a subsidiary motivation in the interviewees' narratives. CONCLUSIONS: Our results contribute to the ongoing discussion of the impact of financial compensation on research participants' assessment of risk. The interviewed women considered all research participants able to make their own choices regarding trial participation, even in the face of financial compensation or payment of study participants. Furthermore, the importance of clinical trials providing new treatments that could change medical practice might be an overlooked reason for trial participation and could be used in future recruitment strategies

A consultation training program for physicians for communication about complementary medicine with breast cancer patients: a prospective, multi-center, cluster-randomized, mixed-method pilot study

BACKGROUND: The aim was to develop and evaluate a training program for physicians for communicating with breast cancer patients about complementary medicine (CM). METHODS: In a cluster-randomized pilot trial eight breast cancer centers (two physicians per center) were randomized to either a complementary communication training program (9 h e-learning + 20 h on-site skills training) or to a control group without training. Each physician was asked to consult ten patients for whom he or she is not the physician in charge. We used mixed methods: Quantitative outcomes included physicians' assessments (empathy, complexity of consultation, knowledge transfer) and patients' assessments (satisfaction, empathy, knowledge transfer). For qualitative analyses, 15 (eight in the training and seven in the control group) videotaped consultations were analyzed based on grounded theory, and separate focus groups with the physicians of both groups were conducted. RESULTS: A total of 137 patients were included. Although cluster-randomized, physicians in the two groups differed. Those in the training group were younger (33.4 ± 8.9 vs. 40.0 ± 8.5 years) and had less work experience (5.4 ± 8.9 vs. 11.1 ± 7.4 years). Patient satisfaction with the CM consultation was relatively high on a scale from 0 to 24 and was comparable in the two groups (training group: 19.4 ± 4.6; control group 20.5 ± 4.1). The qualitative findings showed that physicians structured majority of consultations as taught during the training. Comparing only the younger and less CM experienced physicians, those trained in CM communication felt more confident discussing CM-related topics than those without training. CONCLUSION: A CM communication-training program might be especially beneficial for physicians with less consulting experience when communicating about CM-related issues. A larger trial using more suitable quantitative outcomes needs to confirm this

Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: A randomized pragmatic trial

BACKGROUND: Primary dysmenorrhea is common among women of reproductive age. Non-steroidal anti-inflammatory drugs and oral contraceptives are effective treatments, although the failure rate is around 20-25%. Therefore additional evidence-based treatments are needed. In recent years, the use of smartphone applications (apps) has increased rapidly and may support individuals in self-management strategies. OBJECTIVE: We aimed to investigate the effectiveness of app-based self-acupressure in women with menstrual pain. MATERIALS AND METHODS: A two-armed randomized pragmatic trial was conducted from December 2012 to April 2015 with recruitment until August 2014 in Berlin, Germany, among women aged 18-34 years with self reported cramping pain ≥6 on a numeric rating scale (NRS) for the worst pain intensity during the previous menstruation. After randomization women performed either app-based self-acupressure (n=111) or followed usual care only (n=110) for six consecutive menstruation cycles. The primary outcome was the mean pain intensity (NRS 0-10) on the days with pain during the third menstruation. Secondary outcomes included worst pain intensity during menstruation, duration of pain, 50% responder rates (reduction of mean pain by at least 50%), medication intake, sick leave days and body efficacy expectation assessed at the 1(st), 2(nd), 3(rd), and 6(th) menstruation cycle. RESULTS: We included 221 women (mean age 24.0 (sd 3.6) years). The mean pain intensity difference during the third menstruation was statistically significant in favor for acupressure (acupressure: 4.4 95% CI [4.0; 4.7]; usual care 5.0 [4.6; 5.3]; mean difference -0.6 [-1.2; -0.1], p=0.026). At the sixth cycle, the mean difference between the groups -1.4 [-2.0; -0.8] (p<0.001) reached clinical relevance. At the third and sixth menstruation cycle, responder rate was 37% and 58% respectively in the acupressure group in contrast to 23% and 24% in the usual care group. Moreover, the worst pain intensity (group difference -0.6 [-1.2; -0.02] and -1.4 [-2.0; -0.7]), the number of days with pain (-0.4 [-0.9; -0.01] and -1.2 [-1.6; -0.7]) and the proportion of women with pain medication at the third and sixth menstruation cycle (odd ratio 0.5 [0.3; 0.9] and 0.3 [0.2; 0.5]) was lower in the acupressure group. At the third cycle hormonal contraceptive use was more common in the usual care group than in the acupressure group (odds ratio 0.5 [0.3;0.97]), but not statistically significant different at the sixth cycle (odds ratio 0.6 [0.3;1.1]). The number of sick leave days and body efficacy expectation (self-efficacy scale) did not differ between groups. On a scale from 0-6, mean satisfaction with the intervention at the third cycle was 3.7 (sd 1.3), recommendation of the intervention to others 4.3 (1.5), appropriateness of acupressure for menstrual pain 3.9 (1.4), and application of acupressure for other pain 4.3 (1.5). The intervention was safe and after the sixth cycle two third of the women (67.6%) still applied acupressure on all days with pain. CONCLUSION: Smartphone app delivered self-acupressure resulted in a reduction of menstrual pain compared to usual care only. Effects were increasing over time and adherence was good. Future trials should include comparisons to other active treatment options

Effectiveness and cost-effectiveness of tuina for chronic neck pain: a randomized controlled trial comparing tuina with a no-intervention waiting list

OBJECTIVE: To evaluate whether tuina is more effective and cost-effective in reducing pain compared to no intervention in patients with chronic neck pain. DESIGN: Single-center randomized two-armed controlled trial. SETTING: University outpatient clinic specialized in Integrative Medicine. SUBJECTS: Outpatients with chronic neck pain were randomly allocated to tuina or no intervention. INTERVENTION: Six tuina treatments within 3 weeks. OUTCOME MEASURES: The primary outcome was the mean neck pain intensity during the previous 7 days on a visual analogue scale after 4 weeks (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain). Secondary outcomes included Neck Pain and Disability Scale (NPDS), Neck Disability Index (NDI), health-related quality of life (12-item quality-of-life questionnaire [SF-12]), medication intake, and cost-effectiveness after 4 and 12 weeks. Statistical analysis included analysis of covariance adjusted for baseline values and a full economic analysis from a societal perspective. RESULTS: Altogether, 92 outpatients were included (46 in both groups, 87% female, mean age 45.4 [standard deviation ±9.7], and mean VAS 57.7 ± 11.5). Tuina treatment led to a clinically meaningful reduction in neck pain intensity (group differences, 4 weeks: -22.8 mm [95% confidence interval, -31.7 to -13.8]; p < 0.001 and 12 weeks: -17.9 mm [-27.1 to -8.8], p < 0.001). No serious adverse events were observed. Total costs as well as quality-adjusted life years (QALYs) did not differ significantly between the groups. When taking group differences into account independently from their statistical significance, costs per QALY gained (incremental cost-effectiveness ratio) would range within a cost-effective area from €7,566 (for costs €10.28 per session) to €39,414 (cost €35 per session). CONCLUSION: An additional treatment with six tuina sessions over 3 weeks was effective, safe and relatively cost-effective for patients with chronic neck pain. A future trial should compare tuina to other best care options

Use, applicability, and dissemination of patient versions of clinical practice guidelines in oncology in Germany: a qualitative interview study with healthcare providers

Abstract Background People with cancer have high information needs; however, they are often inadequately met. Patient versions of clinical practice guidelines (PVGs), a special form of evidence-based information, translate patient-relevant recommendations from clinical practice guidelines into lay language. To date, little is known about the experience of PVGs from healthcare providers’ perspective in healthcare. This study aims to investigate the use, applicability, and dissemination of PVGs in oncology from the healthcare providers’ perspective in Germany. Methods Twenty semi-structured telephone interviews were conducted with oncological healthcare providers in Germany between October and December 2021. Interviews were recorded and transcribed verbatim. Mayring’s qualitative content analysis with MAXQDA software was utilised to analyse the data. Results A total of 20 healthcare providers (14 female, 6 male), mainly working as psychotherapists/psycho-oncologists and physicians, participated. Most participants (75%) were aware of the existence of PVGs. The content was predominantly perceived as comprehensible and relevant, whereas opinions on the design and format were mixed. The perceived lack of up-to-date information limited participants’ trust in the content. Most felt that PVGs positively impact healthcare owing to the fact that they improve patients’ knowledge about their disease. Additionally, PVGs served as a guide and helped healthcare providers structure physician–patient talks. Healthcare provider’s unawareness of the existence of PVGs was cited as an obstructive factor to its dissemination to patients. Conclusion Limited knowledge of the existence of PVGs among healthcare providers, coupled with alternative patient information, hinders the use and dissemination of PVGs in healthcare. However, the applicability of PVGs seemed to be acceptable owing to their content and good comprehensibility, especially with respect to physician–patient communication