Responsiveness and minimal important change of specific and generic patient-reported outcome measures for back patients: the Norwegian Neck and Back Register.

PURPOSE: To evaluate responsiveness and minimal important change (MIC) of Oswestry Disability Index (ODI), pain during activity on a numeric rating scale (NRSa) and health related quality of life (EQ-5D) based on data from the Norwegian neck and back registry (NNRR). METHODS: A total of 1617 patients who responded to NNRR follow-up after both 6 and 12 months were included in this study. Responsiveness was calculated using standardized response mean and area under the receiver operating characteristic (ROC) curve. We calculated MIC with both an anchor-based and distribution-based method. RESULTS: The condition specific ODI had best responsiveness, the more generic NRSa and EQ-5D had lower responsiveness. We found that the MIC for ODI varied from 3.0 to 9.5, from 0.4 to 2.5 for NRSa while the EQ5D varied from 0.05 to 0.12 depending on the method for calculation. CONCLUSION: In a register based back pain population, the condition specific ODI was more responsive to change than the more generic tools NRSa and EQ5D. The variations in responsiveness and MIC estimates also indicate that they should be regarded as indicative, rather than fixed estimates.

Norwegian general practitioners' perspectives on implementation of a guided web-based cognitive behavioral therapy for depression: a qualitative study.

BACKGROUND: Previous research suggests that Internet-based cognitive behavioral therapy (ICBT) has a positive effect on symptoms of depression. ICBT appears to be more effective with therapist support, but it is unclear what this support should comprise. General practitioners (GPs) have positive attitudes toward ICBT. However, ICBT is rarely used in regular care in general practice. More research is warranted to integrate the potential of ICBT as part of regular care. OBJECTIVE: The aim of this study was to explore aspects perceived by GPs to affect the implementation of guided ICBT in daily practice. Understanding their perspectives may contribute to improving the treatment of depression in the context of general practice. METHODS: A training package (3-day course) introducing a Norwegian translation of the ICBT program MoodGYM was developed and presented to GPs in Norway. Following training, GPs were asked to include guided ICBT in their regular care of patients with symptoms of depression by providing brief, face-to-face follow-up consultations between modules. We interviewed 11 GPs who had taken the course. Our interview guide comprised open questions that encouraged GPs to frame their responses using examples from their experiences when implementing ICBT. Thematic analysis was chosen to explore patterns across the data. RESULTS: An overall belief that ICBT would benefit both the patients' health and the GPs' own work satisfaction prompted the GPs to take the ICBT course. ICBT motivated them to invest time and effort in improving treatment. The most important motivating aspects in MoodGYM were that a program based on cognitive behavioral therapy could add a structured agenda to their consultations and empower depressed patients. Organizational aspects, such as a lack of time and varied practice, inhibited the use of ICBT. Inadequate knowledge, recalling the program, and changing own habits were also challenging. The GPs were ambivalent about whether ICBT had a negative impact on the doctor-patient interaction in the module follow-ups. Generally, GPs made an effort to recommend MoodGYM, but the expected module follow-ups were often not provided to patients and instead the GPs returned to standard treatment. CONCLUSIONS: GPs' feedback in the present study contribute to our understanding of the challenges of changing treatment for depression. Our findings indicated that recommending ICBT could add to the GP's toolkit. Offering training and highlighting the following aspects may increase recommendation of ICBT by GPs: (1) ICBT is theory-based and credible, (2) ICBT increases the GPs' work satisfaction by having a tool to offer, and (3) ICBT facilitates empowerment of patients in their own health. In addition, the present study also indicated that complex aspects must be accommodated before module follow-ups can be incorporated into GPs' treatment of depression.

Symptom burden and follow-up of patients with neck and back complaints in specialized outpatient care: a national register study.

Back and neck pain are common in the population, especially among immigrants. In Norway's specialist care system, treating these patients typically involves a multidisciplinary approach based on the biopsychosocial model. However, language and cultural differences may create barriers to participation. Immigrants are often underrepresented in clinical studies, but a register-based approach can enhance their participation in research. This study aimed to compare both the symptom burden, and treatment, among Norwegians, non-Norwegians, and patients requiring translator service for back and neck pain within the Norwegian specialist care system. The Norwegian neck and back registry is a National Quality Register, established in 2012 and fully digitized in late 2020. The baseline data includes demographics and patient recorded outcome measures including Oswestry Disability Index, Fear-Avoidance Beliefs, pain rating on a numeric rating scale, Hopkins Symptom Checklist and EuroQol five-dimensional questionnaire on health related quality of life. During the two-year study period, a total of 14,124 patients were invited, and 10,060 (71%) participated. Norwegian patients reported less pain, better function assessed by Oswestry Disability Index, lower fear avoidance beliefs, less emotional distress, and higher health related quality of life compared to non-Norwegians. We found that patients with female gender, who were younger, more educated and exhibited fear-avoidance behavior were significantly more likely to receive multidisciplinary treatment. We found no difference in the proportion of Norwegian and non-Norwegian patients receiving multidisciplinary treatment [odds ratio (OR) 1.02 (95% confidence interval (CI) 0.90-1.16)]. However, patients needing a translator were less likely to receive multidisciplinary treatment compared to those who didn't require translation [OR 0.41 (95% CI (0.25-0.66)]. We found that non-Norwegian patients experience a higher symptom burden compared to Norwegian. We found that both non-Norwegians and patient in need of translator were to a greater extent recommended treatment in primary health care. The proportion of non-Norwegians patients receiving multidisciplinary treatment was similar to Norwegians, but those needing a translator were less likely to receive such treatment.

Motivation to persist with internet-based cognitive behavioural treatment using blended care: a qualitative study.

BACKGROUND: The prevalence of depression is high and results in huge costs for society. Internet-based cognitive behavioural treatment (ICBT) has been suggested for use in primary care and has been shown to be more effective when combined with human support. However, non-completion rates remain a challenge. Current recommendations state that steps to improve persistence with ICBT should be determined and the impact of therapist support on persistence explored. A few earlier studies have explored motivations to persist with ICBT without face-to-face therapist support. The present study explored the motivation to persist as experienced by a group of patients who sought help in primary care and used "blended care", i.e. ICBT supported by short face-to-face consultations. METHODS: To elucidate motivation in an everyday context and the meaning of patients' experiences we chose a phenomenological hermeneutical approach. We interviewed participants in the intervention group of a randomized controlled trial that evaluated the efficacy of an ICBT programme called MoodGYM, an eHealth intervention used to treat depression. Fourteen participants, both completers and non-completers, went through individual, semi-structured interviews after they ended their treatment. RESULTS: Hope of recovery and a desire to gain control of one's life were identified as intrinsic motivators. The feeling of being able to freely choose how, when and where to complete the ICBT modules was identified as an important supporting condition and satisfied the participants' need for autonomy. Furthermore, the importance of a sense of belonging towards partners, friends or family was essential for motivation as was the ability to identify with ICBT content. Another supporting condition was the experience of connectedness when met with acknowledgement, flexibility and feedback from a qualified therapist in the face-to-face consultations. CONCLUSIONS: A key finding was that participants were motivated to persist with ICBT when their overall need for relatedness was satisfied. This was achieved through a sense of belonging towards partners, friends and family. Connectedness with the therapist and the participant's ability to identify with the ICBT modules also gave a sense of relatedness. Improving these motivational aspects may increase patients' persistence with ICBT.

Patients' experiences of helpfulness in guided internet-based treatment for depression: qualitative study of integrated therapeutic dimensions.

BACKGROUND: Quantitative research on Internet-based cognitive behavioral therapy (ICBT) has collected substantial evidence for the effectiveness of this treatment approach on health outcomes. Less is known about how patients find ICBT to be generally meaningful and helpful for treating depression. OBJECTIVE: To explore patients' experiences of being in ICBT treatment with a focus on the treatment dimensions that they considered helpful. METHODS: Choosing a phenomenological-hermeneutical approach, 14 patients were interviewed with semistructured qualitative interviews to elicit their understanding of using ICBT. The patients took part in a clinical trial using ICBT with MoodGYM, which also featured brief consultations with a clinical psychologist. The interviews were transcribed and analyzed according to the chosen methodology and organized into significant themes. RESULTS: The phenomenological-hermeneutical analysis identified 5 themes relating overall to the meaning of this mode of treatment in terms of helpfulness. Two related to treatment in general: (1) taking action to address one's problems and (2) the value of talking to a professional. The next two themes specifically addressed guided self-help using the MoodGYM program: (3) acquiring relevant knowledge, and (4) restructuring the new knowledge acquired through ICBT. A fifth theme concerned (5) actual changes in patients' perceptions and interactions, related to either the self-help material or the face-to-face consultations with the therapist. CONCLUSIONS: Three important dimensions were made explicit: the active engagement of the patient, the guidance of the therapist, and the content of the treatment program. The findings pointed to (1) the role of MoodGYM as a source of new knowledge providing patients with a structured approach to work with their depression, (2) the patient's role as the primary agent of change through adapting relevant knowledge from MoodGYM to their situation, and (3) the dialogue with the therapist as a trusting relationship in which to share thoughts and feelings, receive feedback and advice, and to assist the patient in making use of the MoodGYM content.

Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain.

OBJECTIVES: The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes. STUDY DESIGN AND SETTING: In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect. Credibility of the estimates was assessed by a standardized set of criteria. Responsiveness was assessed by a construct and criterion approach according to COSMIN guidelines. RESULTS: The MIC estimates of RMDQ, ODI and NRS scores varied between a 15-40% reduction, depending on including "slightly improved" in the definition of MIC or not. The MIC estimates for EQ5D were lower. The credibility of the estimates was moderate. For responsiveness, five out of six hypotheses were confirmed and AUC was >0.7 for all PROMs. CONCLUSION: When evaluated in a clinical trial of patients with chronic LBP and Modic changes, MIC thresholds for all PROMs were on the lower spectrum of previous estimates, varying depending on the definition of MIC. Responsiveness was sufficient.

Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial.

OBJECTIVE: To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes). DESIGN: Double blind, parallel group, placebo controlled, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. PARTICIPANTS: 180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017. INTERVENTIONS: Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription. MAIN OUTCOME MEASURES: The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4. RESULTS: In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was -1.6 (95% confidence interval -3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was -2.3 (-4.2 to-0.4, P=0.02) for patients with type 1 Modic changes and -0.1 (-2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group. CONCLUSIONS: In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02323412.